A Food & Drug Administration bit on a Boston Scientific Corp. (NYSE:BSX) bid to expand the indication of its cardiac resynchronization therapy defibrillators to cover patients suffering from milder forms of heart failure.
The decision follows a nod from the FDA’s circulatory systems devices panel in March, recommending the expanded clearance. Boston Scientific’s CRT-D devices were cleared for patients diagnosed with New York Heart Assn. Class III or Class IV heart failure, classified as the most severe cases. An expanded indication opens up a significant new market opportunity for BSX in the $6.7 billion worldwide defibrillator market, according to company officials including CEO Ray Elliott.
The approved expansion of the CRT-D indication seemed likely March 16, when an FDA panel released a report generally supportive of the Natick, Mass.-based medical device giant’s Madit-CRT study last fall, writing that it provided sound evidence of the devices’ effectiveness in reducing heart failure events during a clinical trial that involved more than 1,800 patients.
The panel was less certain about the overall benefits to a wider patient population suffering from milder forms of heart failure. But it was evidently satisfied with the answers given by the company later in March and chose to rule in its favor.
“Any time you complete a big clinical trial like this and an FDA panel agrees that you had a robust study and unanimously votes to approve it, it’s a big win,” Knutson said. “These massive studies don’t come along every day,” Boston Scientific spokesman Dave Knutson told MassDevice after the panel’s psotive recommendation in March.
It’s an especially piquant win for BSX, which suffered through reporting a 7 percent hit to its top line stemming from the hold.
Boston Scientific must conduct two post-approval studies as a condition of FDA approval, according to an FDA press release. One study will evaluate complications and long-term mortality benefits of CRT-D in patients with left bundle branch block identified through the National Cardiovascular Data Registry, and the other will follow patients from the original MADIT-CRT clinical study every six months for five years to assess long-term mortality benefits of CRT-D vs. ICD, according to the agency.
