Study results released ahead of an FDA panel review for Boston Scientific (NYSE:BSX) subsidiary Cameron Health’s lead-free subcutaneous implantable cardioverter defibrillator has some Wall Street analysts wondering whether a substantial market exists for the devices.
Although analysts remained confident that the S-ICD will pass muster with the FDA’s circulatory devices panel on Thursday, concerns about potential safety issues led some to question whether patients would opt for the novel device over traditional ICDs, Reuters reported.
"Our view remains that the Cameron (device), if approved, is likely to be niche product," Goldman Sachs analyst David Roman wrote in a note to investors.
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, Reuters reported. He noted, however, that the safety issues highlighted by the FDA shouldn’t prevent the device from winning approval.
In pre-panel documents, FDA researchers noted that the S-ICD implants, which sit 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, exhibited issues with infections, inappropriate shocks and premature battery depletion.
Last summer, Cameron Health issued warnings on potential battery defects for the S-ICD devices, which won market approval in the European Union in 2009.
In recently released review documents, the federal watchdog agency noted the battery issue and wrote that it is working with Cameron Health to get to the bottom of it, adding that the device will not win U.S. market approval until the defect is resolved.
The FDA also raised concerns about the rate of inappropriate shocks sent by the S-ICD devices. The implants were complication-free at 180 days in 98% of the of 330 patients studied, but nearly 1 in 3 shocks delivered to patients in the trial were later deemed inappropriate, according to FDA documents.
The rate is comparable to other leaded ICDs, the FDA added, but the expert panel will be asked to consider whether the rate of inappropriate shocks is acceptable, particularly considering the limited service life of the device," according to the agency.
Natick, Mass.-based med-tech titan Boston Scientific paid $1.3 billion for Cameron Health, maker of the world’s only lead-free ICD, just last month.
Analysts’ comments on the merger represented a mixed bag of sentiments at the time.
Leerink Swann analyst Rick Wise granted the decision "the potential to transform the longer-term outlook for BSX’s lagging CRM business."
Wells Fargo analyst Larry Biegelsen was more cautious, while still optimistic about future iterations of the S-ICD device.
"Because there are no leads in the heart, this system cannot provide pacing therapy, which many older patients require for a slow heart rate, and it cannot provide pacing therapy to terminate frequent arrhythmias such as slow ventricular tachycardias," Biegelsen wrote. "Many younger patients do not require these therapies and therefore we see this being the primary initial target patient population. We think future generations of the device could address some of these limitations and possibly gain wider adoption."
The S-ICD system will undergo medical expert review on Thursday.
Cameron Health did not respond to requests for comment today.
