It’s FDA Panel review day for Cameron Health’s leadless implantable cardioverter defibrillator (S-ICD), and running one’s finger down the list of questions the expert group has to address is enough to introduce the slightest element of doubt that the clever system will jump the hurdle.
Remember the deal between Cameron Health and its new acquisitor, one Boston Scientific, reportedly releases a further $150M on gaining FDA approval, which in itself is heavily contingent on the outcome of today’s meeting.
So why the concern? Well, the paper on which today’s discussion will be based can be found here and in it, question 6 specifically asks the group the killer question, which is whether the risks outweigh the benefits or vice versa.
What’s clear is that the benefit is the avoidance of an endovascular lead, which is pretty appealing. However the risk that has been unearthed(pardon the pun) during the IDE study lies in the reported delivery of inappropriate shocks, higher rates of infection (than transvenous devices), increased time to deliver therapy and reduced service life.