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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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.
