Cameron Health Inc.’s novel defibrillator used to shock a stopped heart has been tied to inappropriate shocks and infection rates, U.S. regulators said.
A study of the San Clemente, California-based company’s device in 314 patients showed 48 episodes of shocks in 38 patients that were inappropriate and higher infection rates compared with devices with leads inserted through a vein, according to a report released today by Food and Drug Administration staff. Advisers to the agency are scheduled to meet April 26 to discuss the device’s safety and effectiveness.
Boston Scientific Corp. (BSX) agreed in March to purchase closely held Cameron Health for as much as $1.35 billion for the device called the S-ICD System. Boston Scientific fell 1.4 percent to $5.86 at the close in New York. The FDA staff also questioned whether the Cameron Health data is sufficient to assure the device works.
“FDA has raised several questions regarding the totality of the safety and effectiveness data submitted,” agency staff wrote.
Cameron Health also is working with the FDA to understand the root cause of premature battery depletion in the device. The FDA won’t consider approval until the issue is resolved, according to the report. The panel won’t weigh the battery issue.
Ward Dykstra, a spokesman for the company, didn’t immediately return a phone call requesting comment on the staff report.
Cameron Health’s defibrillator, approved in Europe, is implanted completely under the skin, eliminating the need for lead placement inside the heart, the company said. About 850,000 people in the U.S. are at risk for sudden cardiac arrest, which is rapid or chaotic heart activity that leads to loss of function, and are eligible to use an implantable defibrillator, according to the company.
In the study of the Cameron Health device, most of the shocks deemed inappropriate were from oversensing, according to the FDA staff report. Twenty inappropriate shocks represented normal device function and were consistent with what would occur with a defibrillator inserted in a vein.
Patients with the S-ICD System reported 18 infections.
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