Another heart device won a nod from an FDA advisory panel yesterday when Cameron Health’s subcutaneous implantable cardiac defibrillator won rave reviews from the committee, sending Boston Scientific (NYSE:BSX) shares up a tick today on Wall Street
Lofty praise including "simple," "elegant" and "I-should-have-thought-of-that technology" was bandied about ahead of a 7-1 vote by the Center for Devices & Radiological Health’s circulatory devices panel for the S-ICD, which is the target of an offer worth up to $1.35 billion from BSX. Earlier this week the circulatory committee also recommended approval for HeartWare’s HVAD heart pump.
"We were thrilled, obviously, with yesterday, both with the vote and the panel’s feedback," Kevin Hykes, president & CEO of Cameron Health, told MassDevice.com today. The company is targeting the first half of 2013 for product launch if it wins FDA approval, he said, saying the S-ICD device could help restore some of the ICD market’s luster.
"As successful and valuable as [ICD] therapy has been, despite the 100s and 100s of lives it’s saved, it has a bit of a black eye," Hykes told us. "We hope that this product may be a new alternative that addresses some of those concerns and hopefully brings some of those patients and physicians to adopt the therapy."
The Cameron S-ICD, which is slightly larger than traditional ICDs, is implanted under the arm. It’s major innovation is that the leads that transmit electricity to the heart are implanted in a surgically created channel along the patient’s chest, rather than being threaded through blood vessels. The regulating shock is delivered to the heart through the breastbone. Also unlike some other ICDs, the Cameron S-ICD does not provide pacing shocks. Still, the FDA panel fairly waxed rhapsodic over the device ahead of the vote.
"It’s really elegant and simple and a great addition to what we have available," panelist Dr. Richard Lange said, according to heartwire, adding that the device is an example of "I-should-have-thought-of-that technology."
"The opportunity to be able to have a device to, in particular, manage patients who have infections of transvenous [ICD] systems is a very important adjunct to the armamentarium," added Dr. Ralph Brindis. "This device may offer an opportunity for this important therapy to be available to populations who are underserved."
Even the lone holdout on the efficacy vote (the panel voted 8-0 that the Cameron S-ICD meets the safety bar), Dr. David Milan, said he’s hoping the device "will rejuvenate enthusiasm for a field that has been plagued by repetitive reports of device recalls and malfunctions," according to the website.
"I hope this device will get the patients who have a clear indication for a defibrillator but haven’t been treated yet into our offices so we can help them," Milan said, according to heartwire.
His nay vote on efficacy was based on a concern that the study data underpinning the device’s PMA application doesn’t meet "what we’ve come to expect as the standard in the field," Milan said, noting that "the standard is quite high for transvenous systems."
Asked about Milan’s concerns, Hykes declined to comment specifically on any panelists’ comments, but stressed that the S-ICD trial met its efficacy endpoint of 100% efficacy.
"We believe we clearly met the efficacy endpoint and are confident in the device’s ability to treat ventricular tachycardia – as were the majority of the panel members," he said. "We obviously respect and appreciate the time [the panel] spent on this. … [The S-ICD] never failed to convert a ventricular arrhythmia, whether in acute testing or in chronic testing."
The Cameron S-ICD has been on the market in Europe since 2009, where a "surgical" sales approach targeting centers akin to U.S. ICD centers has carved out shares ranging from 3% to 10% of the eligible market, Hykes told us.
Still, some analysts are cautious about the addressable market for the device, given its larger size, painful implantation procedure and lack of pacing technology.
"Many younger patients do not require these therapies and therefore we see this being the primary initial target patient population," Wells Fargo Securities analyst Biegelsen wrote in a note to investors. "This device will improve the company’s visibility in many U.S. accounts and will be valuable product in emerging markets because of its relative ease of implant."
"Our view remains that the Cameron (device), if approved, is likely to be niche product," Goldman Sachs analyst David Roman said.
J.P. Morgan analyst Michael Weinstein agreed, writing in a separate note that the larger S-ICD device, which also delivers larger and potentially more painful shocks, may not be so alluring to patients. He noted, however, that the safety issues highlighted by the FDA shouldn’t prevent the device from winning approval.
Analyst Rick Wise at Leerink Swann was more bullish, writing that the device, although unsuitable for about half of the ICD patient population, could pull down between $280 million and $280 million a year in the U.S. and even more overseas.
"We also expect adoption to be gradual – given the limited experience and ‘first-gen’ device," Wise wrote. "Still, longer-term we envision a sizable niche given the product’s potential to: (1) cannibalize existing ICDs, (2) expand into currently underserved patient populations – e.g., ‘less sick’/younger patients or those who failed or are contra-indicated for transvenous leads, and (3) drive broader emerging markets adoption. Our sense is that the Cameron team believes the S-ICD can address as much as 40% of the market."
The panel decision moves Cameron a step closer to winning FDA approval for the device. While the federal watchdog agency isn’t bound by the panel’s recommendation, it often follows the committee’s advice in making a final decision.
BSX shares opened up 0.01% at $6.22 today following yesterday afternoon’s panel vote, before subsiding to $6.20 as of about 11:46 a.m.