It was supposed to be a closed meeting attended by doctors who had a large amount of experience dealing with patients with St. Jude Medical’s Riata leads, a defibrillator lead that recently garnered an FDA Class I advisory (recall) status due to it’s high failure rate. Only 55 doctors and a few industry personnel were [...]

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. [...]

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 [...]

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 [...]

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 [...]

To capitalize on growing demand from international markets, St. Jude Medical (NYSE:STJ) is launching a new MR-Conditional pacemaker in India that will allow patients implanted with such a pacemaker to undergo a full-body MRI scan safely.The Accent MRI pacemaker, among St. Jude’s roster of new innovative medical devices, is the first MR-Conditional pacemaker to allow [...]

A letter recently sent by St. Jude Medical (NYSE:STJ) to customers regarding a problem with some of the device maker’s defibrillator leads has been classified as a Class I recall — for the most dangerous or defective products — by the U.S. Food and Drug Administration.Although the medical device maker stopped selling the Riata line [...]

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 [...]

St. Jude Medical Inc. (NYSE:STJ) yesterday announced U.S. Food and Drug Administration approval of its highly anticipated Unify Quadra cardiac resynchronization therapy defibrillator (CRT-D) and Quartet Left Ventricular Quadripolar Pacing Lead.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 [...]

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 [...]