The FDA has allowed an expanded indication for Boston Scientific's cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS CRT-D. According to the company, this decision makes Boston Scientific's CRT-Ds the only devices approved for patients in all New York Heart Association (NYHA) classes of heart failure.
The FDA's decision follows a March recommendation from an expert agency panel for the expanded clearance, Mass Device notes. The CRT-D devices were cleared for patients diagnosed with NYHA Class III or Class IV heart failure, and an expanded indication opens up a significant market opportunity for the company in the $6.7 billion worldwide defibrillator market, according to company officials including CEO Ray Elliott, Mass Device notes.
Boston Scientific's good news came as a result of data from MADIT-CRT, the world's largest randomized CRT-D study of NYHA Class I and II patients, with more than 1,800 subjects enrolled at 110 centers worldwide. "The MADIT-CRT trial demonstrated that Boston Scientific's CRT-Ds reduce death and heart failure events, even for patients without symptoms," explains Kenneth Stein, senior VP and chief medical officer, CRM, for Boston Scientific's cardiology, rhythm and vascular group. "Preventing or delaying a first heart failure event in NYHA Class I and II patients with LBBB is critical because these patients are eight times more likely to have a recurring event after their initial event."
Even though the label expansion was expected, it is positive news for the company, Oppenheimer says, according to Benzinga. And this is reflected by the devicemaker's shares, which were up 1.7 percent at $5.48. The stock has dropped 39 percent this year amid fallout from an FDA sales halt of defibrillators after the company didn't get clearance to make certain manufacturing changes, the Wall Street Journal notes.
- see the Boston Scientific release
- get more from the WSJ
- check out the story from Benzinga
- read the Mass Device coverage