It was 20 January 2012. I was doing an EP case at the time. When I emerged from the room to begin typing my orders, a tech said to me: “Hey, did you see this?”

It was a live Twitter feed from the meeting of one of the attendees – an electrophysiologist from Christ Hosptial in Cincinnati, Edward J Schloss, MD. In those tweets were a play-by-play of important discussions and the results of opinion polls fielded during the meeting. Here’s what I saw:

20 Jan Edward J Schloss MD @EJSMD
At Riata ICD Lead Summit in Minneapolis.

20 Jan Edward J Schloss MD @EJSMD
35% of #StJude #Riata Summit attendees think this is a worse problem than MDT Fidelis.

20 Jan Edward J Schloss MD @EJSMD
41% of #StJude #Riata Summit attendees are concerned about Durata and are not implanting it.

20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata US Multicenter Retrospective Trial Riata/ST. Overall failure rate intermediate between Quattro and Fidelis.

20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata bench testing model shows good performance of externalized conductors with or without ETFE insulation breach.

20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata Panel discussants repeatedly emphasize lack of data on natural history of lead. Difficult to reach expert consensus.

20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata Lunchtime conversation: Concern that we’re on the leading edge of failures with these leads. Problem apt to get worse.

20 Jan Edward J Schloss MD @EJSMD
#StJude #RIata Ellis-Vanderbilt series of Riata: 26% of leads had externalitzation flouro abnormalities.

20 Jan Edward J Schloss MD @EJSMD
#StJude @Riata 5 of 10 members of one expert panel use flouro screening routinely (in spite of HRS recommendation against this).

20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata Epstein lecture on extraction points out the unique difficulties associated with this lead. Harder than Fidelis.

20 Jan Edward J Schloss MD @EJSMD
@DeltaAssist I’m booked on flight 3104 MSP to CVG tonight and Delta APP indicates delay with no alternative. Help?

20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata Summit poll at completion: Concern went up – now 58% say Riata problem is worse than Fidelis (up from 35%).

20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata Summit poll at completion: Concern went up – now 44% would not implant Durata (up from 41%)

20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata Summit poll at completion: Concern went up – now 55% favor routine flouroscopy (up from 42%)

20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata Summit poll at completion: More conservative philosophy with externalized conductors 76% would not replace (up from 69%)

In reply to Paul Verrastro 20 Jan Edward J Schloss MD @EJSMD
#StJude #Riata Hauser wrap up: We need to look at Durata very closely “put it under the microscope.” Calls on SJM to create trials

Edward J Schloss MD @EJSMD
@pjv2217 heading to airport.

(Dr. Schloss’s full account of the meeting, with a link to the meeting’s slides and St. Jude’s response to the report, was published recently at the Cardiobrief blog.)

But what was remarkable to me about this whole affair is that a doctor took it upon himself to help report this important information to his colleagues. By doing so, he likely helped many more patients about to receive a new defibrillator system. After all, it is the doctors in concert with their patient, who ultimately must choose which ICD lead gets implanted when a defibrillator is installed.

My hat’s off to Dr. Schoss.

As the market for cardiac rhythm management devices slows in the U.S., medical device makers have been rapidly looking at other avenues for growth.

For St. Jude Medical (NYSE:STJ), one such growth opportunity comes from its highly vaunted fractional flow reserve technology, which is used in conjunction with percutaneous coronary intervention to treat patients with clogged arteries. In a conference call with analysts on Wednesday, St. Jude Medical CEO Daniel Starks said that this technology is “well on its way to a new billion-dollar market.”

Starks noted that St. Jude already controls more than 60 percent of the FFR market.

Last week, the company’s president of its cardiovascular division told MedCity News that the FFR products are showing “significant growth,” but declined to comment further.

Starks’ confidence stems from an unexpected event last week when the Minnesota medical device maker turned heads by announcing that a clinical trial to test FFR was going to be halted early because of very positive results. An independent data review board found that patients who were receiving the FFR-guided therapy were doing so much better than others simply on drug therapy that it would be unethical to continue to randomize patients for that trial.

FFR is a physiological index that can determine the “hemodynamic severity of narrowings in the coronary arteries” and is measured using St. Jude Medical’s PressureWire Aeris and PressureWire Certus. The technology can identify which narrowings are causing the blood flow blockage and can guide an interventional cardiologist to decide which lesions require stents.

Currently, interventional cardiologists perform angiography to know which arteries have been narrowed and blood flow obstructed. On Wednesday, Starks stressed that capitalizing on FFR’s promise will require effective market development to make sure people are aware of the procedure’s benefits.

“Once the clinical data is fully analyzed, published and communicated to payers and the clinical community, we fully expect St. Jude Medical’s FFR technology to be the standard of care for assessing and treating patients with single- vessel and multi-vessel coronary artery disease,” he said.

The Unify Quadra system

Despite its troubles related to the Riata and the Riata ST lead recalls, St. Jude Medical CEO Daniel Starks told analysts Wednesday that the company will gain a 1 percentage point market share in the global cardiac rhythm market in 2012. The company’s CRM segment includes implantable cardioverter defibrillator and pacemaker products.

In discussing the company’s earnings, Starks said that his confidence comes partly from the traction that the company’s new defibrillator system — the Unify Quadra — is gaining in the marketplace.

“In the (eight weeks since the U.S. Food and Drug Administration approved the product), we have signed over 150 new ICD contracts with customers,” Starks said. “Each contract reflects an expected market gain in ICD market share in 2012 in the hospital or health system covered by the contract.”

Later he indicated that the 1 percentage point market share growth in CRM that the company is expecting is likely a conservative figure given that last year without a full launch of the Unify, the company’s CRM market share increased to 26 percent from 25 percent in 2010.

In the quarter ended Dec. 31, the company’s CRM sales were $728 million, a 4 percent decrease compared to the fourth quarter of 2010.

Yesterday, I wrote an article about St. Jude Medical  (NYSE:STJ) that talked about the company’s Optim insulation, part of its Durata lead, which has proved (so far) to be immune to the lead abrasion troubles prompting the company’s  Riata lead recall.

I quoted the company’s CEO Daniel Starks as saying that “we’ve been invested and we’ve been developing a proprietary material that we call Optim, which we began to put into our lead line in 2006.” The lead is 50 times resistant to lead abrasion than silicone used in previous leads, Starks said.

Soon after the article was posted, a reader in U.K. pointed out that Optim is actually not developed by St. Jude Medical at all, but by another medical technology company in which he is an investor.

Turns out, he is right. The silicone polyurethane hybrid that is part of any defibrillator lead sold by St. Jude is actually manufactured in Rogers, Minnesota by AorTech, a wholly owned subsidiary of AorTech International. St. Jude Medical signed an exclusive license with the company in 2006, and rebranded AorTech’s Elast-Eon as Optim. A St. Jude Medical spokeswoman confirmed the relationship and said the company has been involved with AorTech and its predecessor since 1999, and over the years developed and “tested the (Elast-Eon)  insulation material for use with our high-voltage and low-voltage leads.”

AorTech, which is a public company listed on the U.K. stock market,  relocated to Minnesota last fall. Its revenue primarily comes from licensing Elast-Eon and its next-generation product to other medical device companies.

In an interview with MedCity News, AorTech CEO Frank Maguire said that back in the early 2000s, Elast-Eon was shopped to all the major pacemaker companies in the U.S. and U.K. He won’t name names (although it’s not too hard to imagine who they are), but all of  them with the exception of St. Jude Medical took a pass.

“Everyone had the chance to take a look at it, but it was St. Jude Medical who licensed it and they are applying [the] technology in a useful way to make it safer for patients,” Maguire said. “They have succeeded remarkably with this technology.”

So, will Maguire reveal how much St. Jude pays to license the polymer? “Not a chance,” Maguire said.

While the relationship with St. Jude has been good for AorTech, the future lies beyond St. Jude and the cardiac pacing/ICD business. Other applications of the technology are already being cemented — the company has announced applications  in breast implants and sensors.

“Leads are just a small part of the medical device market,” Maguire said.

The Class I recall of the two Riata defibrillator leads from St. Jude Medical (NYSE:STJ) highlighted the issue of lead abrasion and insulation, but both those leads don’t have St. Jude Medical’s Optim technology. When lead abrasion occurs, it can cause the electrical conductors inside leads to come out of the insulation.

Optim is a silicone polyurethane hybrid developed by the Minnesota medical device technology specifically to prevent lead abrasion, explained St. Jude spokeswoman Amy Jo Meyer, and is available in the Riata ST Optim and the Durata leads. More than 250,000 Riata ST Optim and Durata leads have been sold worldwide and were not part of the recall.

In the company’s October conference call with analysts before the Class I recall was announced, St. Jude CEO Daniel Starks provided rare detail about the issue of lead abrasion and the benefit of Optim technology.

… a key theme for us is that although the overall failure rates are low, we have long focused on insulation failure due to abrasion as a problem to solve in our efforts of continuous improvement in our lead technology. And so I’m not sure of the exact time line, it’s been 10 years or so that we’ve been invested and we’ve been developing a proprietary material that we call Optim, which we began to put into our lead line in 2006. Optim is 50 (times) more resistant to abrasion than silicone. You can no longer buy an ICD lead from St. Jude Medical unless it is protected from abrasion by Optim. That’s why at the end of last year, we completely discontinued offering to customers any ICD leads that were unprotected by Optim. Customers can only get the benefit of Optim protection against insulation failures and Optim protection against lead abrasion from St. Jude Medical.

In fact, in the November advisory letter that St. Jude sent to physicians about the issue of lead abrasion and the potential danger of Riata, the company noted that newer leads like Durata had Optim technology weren’t part of the recall.  Meyer, the St. Jude spokeswoman, reiterated that physicians are aware that the Durata leads have the Optim material to guard against lead abrasion.

That might well be true, but physicians don’t appear to be giving the Durata leads a pass, at least for now. The recently concluded Riata ICD Lead Summit (closed to reporters and analysts) showed “41 percent of physicians felt enough concern about the currently marketed Durata lead that they have elected not to implant this lead,” according to Dr. Edward Schloss who attended the summit and compiled a summary.

Schloss wrote that summit organizer Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute, emphasized that Durata leads need to be closely scrutinized. A second survey conducted after the session concluded that a higher percentage — 44 percent — said that they would not be implanting the Durata lead in the future.

Meanwhile, St. Jude Medical has issued a response that basically argues that the Riata ICD Summit did not have enough physicians in attendance — the company says only 55 were polled — to have any meaningful survey responses.

Still, it remains to be seen whether the Optim technology will be able to put the physicians’ fear about Durata at bay.

Certus PressureWire system

Coronary artery disease may have a new enemy.

Interim results of the FAME II clinical trial sponsored by St. Jude Medical (NYSE:STJ), which treated people with coronary heart disease, were so positive that the company announced Wednesday that an independent board had asked that the trial be stopped immediately.

In an interview with MedCity News following that announcement, Frank Callaghan, president of the cardiovascular division, said the results will help to expand the use of  fractional flow reserve  technology in percutaneous coronary intervention (PCI), which suffered a setback back in 2007. That’s because a previous trial showed PCI did not always have better results compared to drug therapy alone. But that trial was performed before FFR was available.

The FAME II trial now shows FFR technology in stenting is much more effective in preventing urgent hospital readmission compared with conventional drug therapy alone to treat clogged arteries.  That meant that continuing to randomize patients for the trial would be unfair to those patients. Hence the trial is being stopped.

“The penetration of FFR in interventional procedures is really quite low today, and we see opportunity to expand that penetration significantly as we develop the clinical data to support that,” Callaghan said.

St. Jude Medical described FFR technology this way:

It is a physiological index used to determine the hemodynamic severity of narrowings in the coronary arteries, and is measured using St. Jude Medical’s PressureWire Aeris and PressureWire Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient’s heart muscle (called ischemia), and guides the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced healthcare costs.

Callaghan would not break out FFR revenue or comment on another analyst’s opinion that FFR was a small portion of the company’s overall revenue, but he said that the products have shown “significant growth” year on year.

“We’re pleased with that,” Callaghan said.

But what he is even more excited about given the performance of FFR is its potential down the road.

“I think it has the potential to benefit all of interventional cardiology and not just stenting, and not just the FFR business,” Callaghan said.

The Accent MRI pacemaker, among St. Jude’s roster of new innovative medical devices,  is the first MR-Conditional pacemaker to allow a high-resolution, full-body scan without compromising the patient’s safety, said a St. Jude spokeswoman.

Scores of people implanted with pacemakers forego MRI scans because the magnetic resonance emerging as a result of the scan can disrupt the functioning of the pacemaker.

St. Jude’s Accent MRI has a new feature called “activator” that competing products don’t have, said Marisa Bluestone, the St. Jude spokeswoman.

An Indian physician confirmed that the activator is a small device that obviates the need for a St. Jude cardiologist or trained technologists to be present at the site where the patient is getting his or her MRI scan. That’s because a single button on the handheld MRI activator device can be pressed to choose the settings already preselected by an implanting physician. Previously, a St. Jude-trained technician at the site of the MRI scan would have to adjust the settings in order to make sure that safety of the pacemaker was not compromised.

“Unlike other MRI pacemakers, the St Jude pacemaker does not require a cardiologist or technologist from the pacemaker company to ‘program’ the pacemaker before the MRI scan,” Dr. Ulhas Pandurangi, chief electrophysiologist at Madras Medical Mission in Chennai, said in an email. “A radiologist who is always present at the MRI scan site may program the pacemaker safely by simply placing the ‘activator’ — a small device half the size of an iPhone — on the (patient’s) skin covering (the) pacemaker.”

Pandurangi added that the accompanying lead that St. Jude was launching in India is very user friendly given that no special skills are required by physicians to use them.

St. Jude Medical’s India manager Kaustav Bannerjee declined to disclose India revenue but implied that the demand for such a product would be strong since heart disease is on the rise in India.

“The World Health Organisation estimates that India is likely to emerge as the global capital of heart diseases by 2025,” Bannerjee said in an email. “However, at times patients have conditions in addition to heart disease and could benefit from an MRI scan at present or in the future. The Accent MRI is an important technology for those patients.”

MR-Conditional pacemakers have made the possibility of getting a MRI scan even with a pacemaker a reality. In the U.S., Medtronic is ahead of its competition in having not only an approved MR-Conditional pacemaker on the market — the Revo SureScan — but is currently testing a next-generation product.

St. Jude Medical's Libra deep brain stimulation system

Symptoms of Parkinson’s disease such as the involuntary movements may be effectively countered by deep brain stimulation.

St. Jude Medical (NYSE:STJ), the Minnesota maker of new innovative medical devices, reported that PD patients who underwent the company’s deep brain stimulation therapy had longer symptom-free periods than those who did not receive it. The data represents the company’s first controlled study designed to see how patients undergoing neurostimulation fared.

Currently, the company’s Libra and LibraXP deep brain deep brain stimulation systems are available internationally, but not in the U.S.

The St. Jude study was conducted at 15 medical centers in the U.S. and involved 136 patients. Results showed that those who received the therapy had an average increase of 4.7 hours in which they did not show dyskinesia, which are the involuntary movements caused by medications used to manage the condition. That compares to an increase of 1.77 hours among the control group that did not receive deep brain stimulation.

The results of the study were published in the Lancet Neurology Journal.

“These results are important as they represent the first large, randomized, controlled study of a constant current device for managing the symptoms of Parkinson’s disease,” said Dr. Michael Okun, administrative director of the University Of Florida College Of Medicine’s Center for Movement Disorders and Neurorestoration, national medical director for the National Parkinson Foundation and the primary author of the article, in a St. Jude news release.

Other results were:

• Motor scores for those in the stimulation group improved 39 percent compared to the baseline as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS).
• There was a statistically significant decrease in the amount of medications needed to control PD symptoms in the stimulation group compared to the group without stimulation.

Although the medical device maker stopped selling the Riata line of leads last year, they were recalled because of the discovery that they had more potential than previously thought to hurt or kill patients. The wires used to connect the defibrillators to the heart may shock patients at inappropriate times or fail to deliver necessary therapy to others, according to St. Jude.

An advisory letter was sent to doctors on Nov. 28 along with recommended instructions for patient monitoring.

The leads remain implanted in 79,000 patients, St. Jude said.

Shares of St. Jude Medical have been in a decline since May, but sunk to a 52-week low on Thursday and fell another 2 percent to $32.93 on Friday. Just two weeks ago, St. Jude shares were trading above $38 after a boost from the approval of the anticipated Unify Quadra cardiac resynchronization therapy defibrillator.

A sluggish heart-rhythm sector has taken a toll on St. Jude; the company’s cardiac rhythm management devices, including defibrillators, provided 56 percent of its total revenue in 2010.

Kensey Nash

The dispute is tied to royalty fees for the Angio-Seal vascular closure device, according to a press statement from the Exton, Pennsylvania medical device company.

The move prompted Kensey Nash to withdraw its guidance for the quarter ending Dec. 31, 2011 and for its first two quarters of fiscal year 2012, sending its share price plunging 23 percent as of 3:16 p.m. Friday afternoon.

Joe Kaufmann, Kensey Nash’s CEO, said in a statement: “St. Jude’s action to reduce the royalty rate to 2 percent suggests that St. Jude Medical intends to assert that their obligation to pay any royalties to Kensey Nash will end in April 2014. Our strongly held view is that, based upon the current design of the Angio-Seal device, St. Jude’s royalty obligations to Kensey Nash extend at least through April 2016, and potentially through 2023. While we are hopeful that mediation will lead to an appropriate resolution of these matters, we will take all necessary steps to protect our intellectual property and the interests of our stockholders.”

Kensey Nash’s business model relies on strategic partners to distribute and sell the products it develops and manufactures.  In October, Kensey Nash saw saw year-over-year net income decline in the first three months of fiscal year 2012, driven by a $4 million drop in collagen product sales following a change to its contract with St Jude Medical. But royalties for the Angio-Seal device account for the majority of Kensey Nash’s royalty revenue.

In a conference call with analysts, Kaufman was optimistic that the dispute could be resolved within the first half of next year, with a conclusion by April.

“We feel going forward we will prevail,” said Kaufman.

St. Jude Medical (NYSE:STJ) finished the day with a nearly 8 percent jump in stock price after announcing the U.S. Food and Drug Administration approval of its long-awaited Unify Quadra cardiac resynchronization therapy defibrillator and Quartet Left Ventricular Quadripolar Pacing Lead.

St. Jude’s stock closed at $38.44, up 7.7 percent over the previous day. But was it all Quadra? It was a good day for the stock  market overall, though St. Jude’s stock price rose higher than most of its peers: Medtronic (NYSE:MDT) climbed 4.35 percent, Boston Scientific (NYSE:BSX) was up 6.31 percent (Boston Scientific received approval for three cardiac medical devices).

However, STJ’s stock price is still below a spike the stock received after its earnings in October.

Quadra is the cream of a series of upcoming products that excite analysts about St. Jude. The Quadra and Quartet use a pacing lead with four electrodes, which enables more pacing configurations and reduces common problems associated with implantable CRT systems, and ultimately results in fewer surgeries for patients.

“We estimate Quad-Pole technology from Medtronic Inc. and Boston Scientific Corp. are at least one to two years behind Quartet, so St. Jude has a meaningful lead,” Bloomberg quoted Larry Biegelsen, a Wells Fargo Securities analyst in New York, in a note to investors.

This is the industry’s first quadripolar pacing system, which the St. Paul, Minnesota-based medical device maker says allows cardiologists to better manage CRT.

Defibrillators are implanted in the chest and usually connected to the heart with leads, synchronizing the heart’s lower chambers — which are often out of sync in heart failure patients — so they are more efficient in pumping blood to the body. The Quadra and Quartet use a pacing lead with four electrodes, which enables more pacing configurations and reduces common problems associated with implantable CRT systems, and ultimately results in fewer surgeries for patients.

“Based on the clinical experiences and publications to date, this innovative CRT system has the potential to redefine the standard of care in resynchronization therapy for heart failure patients around the world,” said Dr. Eric S. Fain, president of the St. Jude Medical Cardiac Rhythm Management Division, in a statement.

Analysts agree. They expressed excitement over the pending U.S. launch of the Quadra earlier this year, and in March, J.P. Morgan analyst Michael Weinstein called it the most important new product in the space since 2002, which caused St. Jude shares to surge 6 percent.

Weinstein surveyed 50 cardiologists and found that 92 percent of them expected the type of lead system used in the Quadra to become the standard of care.

Upon news of the approval, Morgan Keegan reiterated its Outperform rating and $53 target price for St. Jude, saying, “This should be a strong positive for St Jude’s CRT-D business, and when combined with the accelerating replacement cycle, should allow the company to continue to take share from competitors Boston Scientific Corp. and Medtronic Inc. — the European experience has been positive.” Canaccord maintained its hold rating and $42 target. St. Jude stocks were up 6 percent this morning.

But not everyone is so optimistic. ICD competitor Boston Scientific’s CEO Ray Elliot trashed the product in May, and called it “99 percent hype.”

About 2 million new cases of congestive heart failure are diagnosed each year, but the market for ICDs has slumped in the past year following a controversial report and proceeding U.S. Department of Justice investigation of overuse of the devices.

Market competitors Medtronic and Boston Scientific have suffered in ICD sales, too. Both device makers are developing similar lead technology, but are reportedly at least 18 months behind St. Jude.

The Quadra should boost St. Jude’s share in the defibrillator market. An earlier version, Promote Quadra CRT-D, was approved in India in September and in Europe in May 2010. The company said it will begin shipping the products in the U.S. immediately.

Net income fell to $2.2 million in the three months ended September 30 compared with $3.8 million the previous year.  Net sales increased 29 percent to $14 million.

Its orthopedic product category rose exponentially to more than $12 million for the quarter, compared with $5.3 million the previous year, boosted by sales from its May acquisition of West Chester, Pennsylvania neighbor, Norian.

Joe Kaufmann, president and CEO of the regenerative medicine company said: “Our sales for the quarter increased 29% over prior year driven by strong organic growth in spine and sports medicine along with a major contribution from our recent Norian acquisition, which more than offset the loss of over $4 million in St. Jude collagen product sales. Although our earnings declined year over year, as we anticipated due to the loss of the collagen sales and an increase in R&D expense, we expect to see improvement throughout the balance of the fiscal year.”

Kensey Nash’s business model relies on strategic partners to distribute and sell the products it develops and manufactures.   In its annual report for fiscal year 2011, it said its four largest customers accounted for roughly 86 percent of its total revenues:  St. Jude Medical, Arthrex, Orthovita, and Synthes.

Orthovita’s acquisition by Stryker (NYSE: SYK) in June and Synthes agreement to be acquired by Johnson & Johnson (NYSE: JNJ) in April could make a significant difference in the company’s future. Other customers include Johnson & Johnson, Medtronic (NYSE: MDT), Stryker, Devicor Medical Products and Zimmer.

St. Jude Medical (NYSE:STJ) reported strong earnings and buyers responded, pushing the company’s stock price up 4.3 percent to $38.95. While profits were up notably, the focus is on St. Jude’s robust – albeit delayed – pipeline of products.

Primarily, analysts and shareholders are eager for the delivery of Quadra, a slightly delayed cardiac therapy device that is expected to be a major win for the company while cutting into the market share of the Boston Scientific. Quadra’s four leads and new wires are able to connect to the heart and make it easier for physicians to avoid side effects from devices that had only two leads.

Analysts can’t wait for its arrival.

St. Jude’s forecast brackets the analyst consensus of $3.27 a share and suggests 8 percent to 9 percent annual growth, said Michael Weinstein, an analyst at JPMorgan Chase & Co., in a note to clients today. The company is still waiting for U.S. regulatory approval of its quadripolar cardiac-resynchronization therapy lead, known as Quadra, which management has said it expected early in the fourth quarter.

While the forecast “implies a lower fourth-quarter earnings per share number than the Street had previously been modeling, $0.83 to $0.85 versus $0.86, we expect this to be seen as acceptable to investors in light of what’s played out in the ICD market in 2011 and the ongoing delay to Quadra,” Weinstein wrote. The market for implantable cardioverter defibrillators, or ICDs, plunged in the past year amid a U.S. Justice Department investigation and questions of overuse.

But it’s  not only Quadra. St. Jude’s success will be tied to its ability to deliver a series of new products or apply new uses to older products, such as a neurostimulator to treat migraine headaches.

“St Jude’s challenge has always been to take the focus off the big business and refocus it on the smaller parts of the business,” Reuters quoted Nuveen Asset Management analyst Tim Nelson as saying.

All this pipeline innovation is driven by the fact that the heart-rhythm sector continues to be sluggish. St. Jude Medical gets half its revenue from heart rhythm devices. But on Wednesday’s conference call CEO Dan Starks described it as a “tough market” with “a number of distressed conditions,” but also added “it seems to be reasonably steady state.”

St. Jude Medical (NYSE:STJ) this week rolled out one of its heart imaging products in India: the C7-XR Optical Coherence Tomography (OCT) Intravascular Imaging System with the C7 Dragonfly Imaging Catheter. It’s a natural addition to the St. Jude product line in the country. The imaging system is used by interventional cardiologists to help with stent implantation.

St. Jude thinks its optical coherence tomography business is the shining star of the vascular division, and considers itself the global leader in the segment since its acquisition of LightLab. St. Jude has also recently launched the PressureWire Certus and PressureWire Aeris Wireless FFR Measurement Systems, which work with the OCT product.

From Mayo to St. Jude to Medtronic, India is increasingly everyone’s favorite med-tech consumer.

Other key technologies in India include:

• Quadripolar CRT-D, Unify CRT-D and Fortify ICD
• AFocus II diagnostic mapping catheter
• Therapy Cool Path ablation catheter

Version 5.0 features an alert notification system that will contact a physician on his or her mobile device when a patient has an event triggering an alert. The physician can read the alert transmission directly, in addition to being able to immediately access electrocardiograms, the patient’s contact info and other key information, instead of having to log into a computer to access patient records, which is difficult when out of the office. It also will allow the physician to respond and follow up more quickly.

The DirectAlerts notifications can be customized to one’s schedule and are compatible with several mobile devices, including the iPhone, Android, iPad and Blackberry.

St. Jude’s Merlin platform will be the basis for monitoring technology, which the company has stated they hope to introduce in India, though no time line was specified.

It appears that pharma stocks fared better than medical device and biotech stocks. GlaxoSmithKline (NYSE:GSK) was down a mere 28 cents to close at $39.44 on Monday. Pfizer (NYSE:PFE)  was down 45 cents to $16.66. Abbott Laboratories (NYSE:ABT), however, fared a little bit worse with its share price falling by $1.24 to close at $48.06.

In the world of medical devices, Boston Scientific (NYSE:BSX) came home least battered with its share price falling only 29 cents to close at $6. However, its single-digit stock price doesn’t really afford much comfort. Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ) both had reductions of more than $2 each to their share prices, which fell to $31.07 and $41.12 respectively. Stryker (NYSE:SYK) closed at $47.43 after a drop of $1.51, while Zimmer (NYSE:ZMH) was at $53.90, down $1.76.

Biotechnology stocks like Amgen (NASDAQ:AMGN)  was cut to $49.88, a decline of $1.78 . Gilead Sciences (NASDAQ:GILD) slid only 22 cents to close at $36.82, while Biogen Idec (NASDAQ:BIIB) took a bigger hit dropping $3.29 to finish at $88.

These are just a sampling of some stocks in each sector and how they survived Manic Monday. Feel free to add how other stocks weathered the maelstrom in the comments section.

St. Paul, Minn.-based St. Jude’s board of directors authorized up to $500 million to repurchase shares, which will be made available for general corporate purposes and for offsetting dilution associated with employee benefit plans.

St. Jude, which ranked 15th in the MassDevice Big 100 list of the world’s largest medical device companies, had about 330 million shares of common stock outstanding at its last count, according to the release.

St. Jude reported a $241 million profit on about $1.44 billion in sales during the second quarter ended July 2, a 5.5 percent drop from the $254 million profit the company made on $1.31 million during the same period last year.

Included in the company’s earnings was a $32 million restructuring charge related to the shuttering of a Swedish manufacturing facility for CRM products in favor of more affordable locations in Puerto Rico and Malaysia, which will result in the loss of about 450 workers.

San Diego, Calif.-based Illumina plans to repurchase $100 million shares, which will add to the $100 million share repurchase program that ended last week.

“Since 2008, we have bought over 12 million shares of our common stock through prior authorizations, returning nearly $450 million to shareholders,” Illumina’s senior VP, general manager of life sciences and CFO said in a release. “Through the board’s new authorization, we expect to continue our share repurchase programs.”

Illumina had a pretty strong quarter, touting $287 million in sales in the three months ended July 3, a 36 percent increase from the $212 in sales posted for the same period last year.

The diagnostics company’s profits came in at $30.6 million, or 22 cents per diluted share, a 3 percent increase from last year’s $29.8 million, or 21 cents per diluted share.

Irving, Texas-based UMCSC announced a one-year contract for cardiac rhythm management products with St. Jude this week, complementing an existing agreement with Boston Scientific Corp. (NYSE:BSX) and replacing an agreement with Medtronic.

“The 33 members of the Upper Midwest Consolidated Services Center (UMCSC) spend more than $110 million annually on CRM devices including pacemakers, implantable cardioverter defibrillators, heart failure devices, leads and related accessories,” according to the press release.

UMCSC relies on fellow Lone Star State company Novation and the suppliers its collaborates with to shape its product portfolio, company officials said.

Medtronic made headlines — and pleased Wall Street — when it canceled several contracts for its cardiovascular and orthopedic products with Novation worth an estimated $2 billion a year. A few weeks later the Fridley, Minn.-based medical device giant spiked a deal with Premier Inc. for some of its spine products.

At the time, J.P. Morgan Chase & Co. analyst Michael Weinstein told the Wall Street Journal that spiking the Novation deal represented “a watershed moment” that could send ripples through the entire industry, positing that Medtronic would ditch other GPO deals as well.

But those ripples never materialized, as MDT rivals rushed to fill the vacancies left by the Fridley, Minn.-based firm.

Novation announced new partnerships of its own, adding electrosurgical and advanced cutting and coagulation products to its supply that it estimates will save $4.1 million for its members annually, according to a press release. Deals were struck with Covidien plc (NYSE:COV) , DeRoyal, Megadyne, Xodus, Buffalo Filter, Medline and Unimed, the company reported.

A review of life science current events reported by MedCity News this week:

St. Jude Medical job cuts to affect 450 by end of 2012. St. Jude Medical (NYSE:STJ) will lay off 450 people by the end of next year as it moves manufacturing of its cardiac rhythm management products from Sweden to Puerto Rico and Malaysia.

The roller coaster of Neoprobe. The hedge fund manager Neoprobe investors love to hate isn’t eager to take credit for the cancer diagnostics company’s free-falling stock price. But Neoprobe’s shares are down 40 percent since short-seller Martin Shkreli began agitating about the company’s radiopharmaceutical, Lymphoseek. Meanwhile, Neoprobe remains on track to file a New Drug Application for Lymphoseek this quarter.

LabCorp to pay $49.5M to settle Medicaid fraud suit. Burlington, North Carolina-based LabCorp disclosed the proposed settlement payment in a securities filing. During today’s second quarter earnings conference call, LabCorp executives did not discuss the lawsuit or the settlement other than to repeat what was disclosed in the filing that said that the company is settling “to avoid the uncertainty and costs associated with prolonged litigation.”

PPD: For sale or not for sale? The Wall Street Journal cited unnamed “people familiar with the matter” in reporting on Sunday that Wilmington, North Carolina-based PPD is exploring a sale. The Journal said the CRO could attract interest from private equity as well as other CROs. That prompted the clinical research organization to publicly state it is not in talks with any other CRO regarding a merger or acquisition.

Instead, he was greeted by a simile.

“We are like the duck that looks calm on the surface with the feet pedaling furiously below the surface,” said a coy Dan Starks, chief executive of St. Jude Medical.

Renal denervation is used to treat hypertension, or high blood pressure, by the ablation of the nerves that line the renal arteries using a catheter.

In his prepared remarks before taking questions from analysts, Stark described renal denervation as a major new growth market. He added that the company expects European regulatory approval before the end of 2012.

Although he would add little more, the comment reveals that the time line for clearing the regulatory hurdle has moved up. Presentation slides from an investor conference in February show that the company expected European approval in 2013. The company plans to submit an investigational device exemption application to the U.S. Food and Drug Administration next year.

St. Jude believes that about 76.4 million Americans suffer from high blood pressure and worldwide the number stands at 1 billion. The annual direct cost to treat this condition globally is $500 billion.

While St. Jude Medical ramps up its efforts in renal denervation, its in-state competitor has recently won FDA clearance to begin enrolling patients in a randomized clinical trial across 60 U.S. medical centers. Medtronic’s $800 million-plus acquisition of Ardian brought the Simplicity renal denervation catheter system within its product portfolio and company officials are more than optimistic about the product’s potential. The Simplicity system is already available in Australia.

“We view renal denervation for the treatment of uncontrolled hypertension as one of the most exciting growth markets in medical devices,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral Business at Medtronic, in a statement that announced the acquisition.

The job cuts were prompted by a continued weakness in the CRM market domestically.

“U.S. CRM sales fell into a pot hole,” said Dan Starks, president and CEO of St. Jude Medical, in a conference call with analysts on Wednesday, adding that 28 percent of overall sales comes from the U.S. CRM division.

U.S. CRM sales were $401 million in the quarter. Last year it stood at $440 million. Of CRM domestic sales, St. Jude was hurt by falling revenue from implanted cardioverter defibrillators (ICDs) , which saw a 9 percent decline to $300 million compared with the second quarter of 2010.

Adding international markets, however, global ICD sales were at $477 million in the quarter ended July 2, a 1 percent increase compared with the second quarter of 2010.

St. Jude Medical and its competitors have all been affected by a slowdown in the U.S.  market for ICDs, partly due to a slower economy, but also due to a Department of Justice investigation.

Overall in the quarter ended, the company saw profits decline to $240.9 million, or 72 cents per share, from $254 million, or 77 cents per diluted share. Even as profits fell, revenue jumped 10 percent to $1.45 billion in the second quarter, up from $1.31 billion.

St. Jude was also forced to reduce its revenue guidance for the CRM division for the second half of 2011. Starks said that he believes that the global CRM market will shrink 2 percent in the second half of the year, and as a result the company’s sales would be reduced by $130 million to $135 million.

Now company officials expect full year revenue from the CRM division will be between $3.06 billion to $3.12 billion. That is lower than the $3.16 billion to $3.25 billion that the company estimated during a conference call in April.

The revised guidance was expected by Morgan Stanley analyst David Lewis, who thought that St. Jude had a too-aggressive guidance in CRM products related to the second half of the year.

The Minnesota maker of new innovative medical devices said the system is the world’s first and only diagnostic tool that integrates optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform.

FFR is a guide wire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. OCT provides noninvasive cross-sectional imaging of biological tissue.

St. Jude’s Ilumien system has the St. Jude Medical PressureWire Aeris, a wireless interventional tool that measures FFR to evaluate how bad the blockage is in coronary arteries preventing blood flow. It also comprises the C7-XR OCT diagnostic imaging technology with Extreme Resolution, a novel intravascular imaging technology that allows physicians to see and measure  vessel characteristics either invisible or difficult to assess using older imaging technology.

Combined, the two technologies help to optimize percutaneous coronary intervention (PCI) by increasing a doctor’s ability  to identify lesions responsible for causing ischemia and in providing accurate measurements.

The Ilumien system also has a wireless device that enables it to receive aortic pressure readings from the catheterization lab.

“Knowing which lesion to treat and how to treat it is the key to optimizing interventional treatment strategies,” said Frank Callaghan, president of the the company’s cardiovascular division, in a statement. “We believe integrating these technologies is key to providing physicians a simplified, streamlined option for the diagnosis and treatment of patients with coronary artery disease.”

St. Jude’s cardiovascular division garnered $327 million in the first quarter, up 28 percent over the first quarter of 2010, including  $6 million of favorable foreign currency translations.

The clearance is the first of its kind for the U.S. The device allows physicians to place multiple neurostimulation leads and different types of leads through a single entry point, reducing the need for the multiple incisions typically required.

The device also allows a physician to implant STJ’s S-series paddle leads, which previously required a more invasive surgery that typically means removal of part of the vertebral bone.

Neurostimluation, or spinal cord stimulation, sends mild electrical impulses via a lead that is placed near the spine to interrupt or mask pain signals on their way to the brain. The treatment is typically used to manage chronic pain in the trunk or limbs, and often in treatment of failed back surgeries.

St. Jude is also experimenting with using deep-brain stimulation for the treatment of another kind of pain – depression.

The St. Paul, Minn.-based company’s systems compete against some of the biggest players in the med-tech arena. Medtronic Inc. (NYSE:MDT), who won CE Mark for a fully implantable peripheral nerve stimulation device in May 2011. Boston Scientific Corp. (NYSE:BSX) won FDA clearance for its lead system in August 2010.

St. Jude  announced Monday that the Broaden severe depression study that is testing its Libra investigational device will now be conducted at 20 medical centers with a total of 125 patients. Before the FDA approval, the study was being conducted at three centers in Chicago, New York and Dallas.

Similar studies are being conducted outside the U.S., said Rohan Hoare, St. Jude’s vice president, research and development. The company believes the market opportunity for deep brain stimulation to treat depression is more than $1 billion.

Deep brain stimulation works by sending mild pulses of current from an implanted device to stimulate the brain. DBS leads are surgically placed within a target area in the brain and connected to a neurostimulator that is usually implanted under the skin near the collarbone.

“We are committed to leading this important research in hopes of finding a solution for people who currently don’t have a treatment option,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division, in a statement. “By expanding the Broaden study, we are able to continue to add to the body of evidence that will determine if deep brain stimulation is indeed an option for managing major depressive disorder.”

Patients who fit a specific profile can only be enrolled in the Broaden study. The criteria are that the patient has to have been clinically  diagnosed with major depressive disorder (MDD), be  between 21 and 70 years old, has experienced  his first depressive episode before age 45 and  has tried at least four treatments in his current episode such as  different medications, different combinations of medications, and/or electroconvulsive therapy.

The National Institute of Mental Health (NIMH) estimates that there are 21 million adults in the U.S. who suffer  from some kind of depressive disorder, and of these, about 4 million live with severe depression that cannot be controlled by medications, psychotherapy and in certain cases, ECT.

Deep brain stimulation can help to manage the condition and provide symptom relief, but it is not a cure,  according to the Mayo Clinic’s website,

St. Jude’s Libra DBS treatment for depression is not approved in the U.S. But St. Jude has launched the Libra platform to manage Parkinson’s disease in  DBS in Europe and Australia. That is a $500 million market, according to company officials.