HeartWare International's blood pump and Cameron Health's under-the-skin defibrillator go before an FDA panel of experts this week whose recommendation could make or break their chances for marketing approval. But regulators in advance of the hearings are issuing mixed evaluations for both products.
FDA staff concluded that data for the HeartWare ventricular assist system showed a high rate of patients who experienced blood clot-related pump failure. But the agency acknowledged that the device seems to aid people with severe heart failure, according to a Reuters report that summarizes the evaluation. Of the 250 people implanted with the device, 16 suffered blood clot-related pump failure, and 15 needed replacement pumps, the story notes. The device is billed as the first ventricular assist device that doesn't need a separate abdominal pump pocket, and it is indicated to help patients waiting for a heart transplant, according to the FDA.
On the other hand, Cameron may be in trouble with its defibrillator that's implanted under the skin to treat a dangerously irregular heartbeat. The FDA review concluded that the device may not be any better than similar products on the market and also appears to lead to more infections, according to a separate Reuters story. That article also notes that regulators won't approve the device until an issue with a battery that wears down too soon is resolved. This could be a problem for Boston Scientific ($BSX), which recently agreed to buy the company. Cameron's device is designed to treat patients with life-threatening ventricular tachyarrhythmias, according to the FDA.
The agency conducted both reviews in advance of hearings scheduled for April 25 and 26, with the agency's Circulatory System Devices Panel of the Medical Devices Advisory Committee. HeartWare has its hearing April 25, and Cameron steps up a day later. Regulators don't have to abide by the panel's recommendations for or against approval, but they typically do.
- read the Reuters story on HeartWare
- check out the news agency's Cameron Health piece
- here's the FDA meeting announcement