Implanted cardioverter defibrillators, which shock the heart back to life when a person suffers heart failure, have been plagued with controversy.
In recent years, there has been federal scrutiny of relationships between doctors and device makers, and a drop in physicians implanting ICDs after an article in an influential medical journal said they are overutilized.
But perhaps nothing has hurt ICD makers more than the charge that sometimes the devices fail and may be unsafe. There have been several high profile recalls and safety warnings of ICDs stemming from lead failure and battery depletion.
And now Boston Scientific, which had to deal with its own ICD kickback and safety issues related to its Guidant acquisition in 2006, is hoping that a company it intends to acquire can put the safety issue to rest.
The company’s Cardiac Rhythm Management Division has pinned its hopes on Cameron Health, a California company that makes the world’s only commercially available subcutaneous ICD that does not require leads in the heart. The product is currently being reviewed by the U.S. Food and Drug Administration.
In an interview with MedCity News, the chief medical officer for Boston Scientific’s Cardiac Rhythm Management Division, said that the product is revolutionary because it removes the need to have a lead in the heart.
“We have known for years that the lead is the weak link in the ICD system,” said Ken Stein. “When you think about it, the normal human heart beats about 100,000 times a day and over the course of the year that’s 30 million-odd heartbeats a year … and that’s an awful lot of stress to put on a mechanical device inside the heart.”
Cameron’s S-ICD system has an electrode placed under the skin, but there are no transvenous leads in the heart.
“So [by] having an option for defibrillation without having to go inside the heart and the blood vessels itself, we expect that in the long run we will see a big advantage in terms of reduced rate of complications with the implant, reduced rates of complications due to lead failure over time and reduced rate of infections,” Stein said.
Stein implied that the S-ICD system is path breaking.
I can remember when [defibrillation] technology was first developed. We had to do open heart surgery and put patches directly on the heart itself. And then a huge revolution was when the first endocardial lead was developed at Guidant at the time. [Cameron Health's product] to me in scale is as big a revolution as that one. I think we have progressively made this technique less and less invasive — from open heart surgery to endocardial lead to not having a lead in the heart at all.
CRM President Joe Fitzgerald suggested that Boston Scientific will benefit from first-mover advantage.
“We believe that Cameron is substantially ahead of anything else that we see,” Fitzgerald said. “The way we judge that is do we see a subcutaneous ICD in clinical trials anywhere in the world. That’s usually the first signal that anyone has a viable program and we don’t see that.”
While that may be true, only time will tell whether S-ICD will be a blockbuster product for Boston Scientific. Some analysts have noted that the first generation of the product is limited in that it doesn’t provide pacing for the heart that is needed by older patients, according to Bloomberg.