A Food & Drug Administration panel approved 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 from the FDA’s circulatory systems devices panel came late Thursday afternoon. The company’s current indication is 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, according to company officials.
It’s a much-needed boost for for Boston Scientific’s cardiac rhythm management business as it struggles through a rough week. The company voluntarily stopped all shipments of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and pulled its inventory from the field after discovering that it missed a pair of filings with the FDA.
News reports estimate that the hold could last as long as a month as BSX files for a 30-day supplement to its pre-market approval from regulators to clear up the paperwork issue. Agency officials have said they are not aware of any safety concerns regarding the devices.
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 today and chose to rule in its favor.
Boston Scientific spokesman Dave Knutson told MassDevice that the panel’s recommendation still needs to be approved by the FDA before the company can begin actively marketing the device to new patient populations, something he expected to happen by the middle of 2010.
“If it gets approved, then it’ll be a great day for patients, because physicians will have the ability to implant in Phase I and II patients,” Knutson told us. “Hopefully this will keep them healthier longer.”
If the FDA goes along, Knutson said the company will ramp up its sales efforts to take advantage of the expanded indication.
He called it a significant achievement for the company.
“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.”