Cameron Health landed an April date with the FDA’s circulatory devices panel to review a pre-market approval application for its lead-free subcutaneous implantable cardioverter defibrillator, or S-ICD.
The S-ICD system, unlike traditional ICDs, sits just beneath the skin and does not rely on wires relayed through blood vessels and connected to the heart in order to provide heart rhythm therapy.
The device, which has been the only lead-free cardiac rhythm implant on the market since winning CE Mark approval in the European Union in 2009, will get the FDA treatment on April 26, according to the watchdog agency.
Cameron filed its PMA in December 2011, making the quick FDA turnaround a positive sign for its steward-to-be. Nevertheless the news didn’t win much love from Wall Street today, where BSX shares were down 7¢ to $6.05 as of about 3 p.m.
"To us, FDA scheduling a panel to review the lead-less ICD so urgently … could suggest basically 2 things," analysts at Leerink Swann wrote in a note to investors. "(1) FDA must believe this is important new technology – particularly in the context of ongoing transvenous lead performance concerns (which the S-ICD aims to avoid), (2) FDA must have a basically positive bias toward the technology."
Either way, that’s a windfall for med-tech titan Boston Scientific and a possible setback for Edwards Lifesciences (NYSE:EW), which is not now likely to win its own panel date in April to review the "high-risk" patient group, cohort A, in its Sapien transcatheter heart valve PMA bid.
"Based on the FDA’s tentative panel meeting calendar, the next possible date for an EW Sapien panel now appears May 24," according to the analysts. "Clearly, the longer cohort A approval drags out, the more risk to numbers and the greater the likelihood of further downward estimate revisions."
EW shares were down 1% to $70.75 in late afternoon trading.