Good news for Cameron Health (and Boston Scientific ($BSX)). An FDA panel voted Thursday 7-1 to recommend approval of the company's implantable defibrillator. And if the agency ultimately signs off on it, Cameron's offering will be the first subcutaneous implantable defibrillator available in the U.S.
It wasn't a given that Cameron would score this win. An FDA report released earlier this week concluded that the device may not be any better than similarly marketed products and it seemed to lead to more infections. But the company seems to have overcome such concerns.
In fact, panel members seemed very impressed by the offering, as TheHeart.org notes. The Cameron device is "I-should-have-thought-of-that technology. It's really elegant and simple and a great addition to what we have available," marveled Dr. Richard Lange of the University of Texas at San Antonio, as quoted by the news service.
Physicians already are positive about the treatment. "The S-ICD System is a breakthrough technology that holds promise as a new alternative for treating patients at risk for sudden cardiac arrest," said Dr. Michael Gold, professor of medicine and chief of cardiology at the Medical University of South Carolina, in a statement. "The S-ICD System provides the same defibrillation protection as conventional ICDs, but without the serious complications associated with leads that reside in the heart and blood vessels."
So, the panel's vote is a big win for Cameron--and in more ways than one. Last month, Boston Scientific decided to exercise a long-held option to buy the company for an initial $150 million. That price tag could grow by a little more than $1 billion upon a regulatory sign off by the FDA and subsequent revenue milestones 6 years after that.
Boston Scientific rivals Medtronic ($MDT) and St. Jude Medical ($STJ) also make implantable defibrillators. So it should come as no surprise that Boston Scientific might make a move for a company like Cameron. Although it was pleased about the panel's decision, it didn't comment further in an emailed statement to FierceMedicalDevices because the transaction hasn't been concluded.
Still, a quick approval isn't assured, as the company needs to address concerns over battery life. That said, the FDA did acknowledge that the product's elimination of a lead wire into the heart was a "primary benefit." And given St. Jude's recent problems with its Riata leads, this benefit could prove to be a huge asset, as Dow Jones notes.
A happy Cameron CEO Kevin Hykes expressed hope that the FDA might take action by the end of the year. "Despite some controversy lately, defibrillation therapy is a life-saving therapy that has changed some lives," he said in an interview with Reuters. "(Today) is a big day for Cameron Health, and an even bigger day for patients."
- get Cameron's release
- check out TheHeart.org report (sub. req.)
- see the Reuters story
- read the Dow Jones article (sub. req.)