On Wednesday, after several hours of hearings, the Circulatory System Devices Panel voted 9-2 that the product's benefits outweighed any risks, 11-0 that the device is effective (many raved about its design) and 8-3 that it is safe, according to coverage in Bloomberg, Reuters, Forbes and MedPage Today, among others.
While it's true the vote is non-binding, and the FDA doesn't have to follow the panel's recommendations, the regulatory body usually does. This fact bodes well for HeartWare gaining approval for the device in the U.S. In addition, the vote had enough of a potential impact that NASDAQ halted trading of HeartWare shares until the outcome was clear.
In advance of the hearing, FDA staff had expressed worries that the device generated high stroke rates and wanted to see more study data. But HeartWare designed the device to aid those patients suffering from severe heart failure and waiting for a transplant. It's already being used in Europe. And some panel members argued that in spite of the risks, the pump gives dying patients a viable alternative, according to the Bloomberg story and other sources.
The device will be implanted next to the heart without the abdominal surgery required for competing devices, including Thoratec's HeartMate II, which has been on the market for a few years, Bloomberg noted. In the company's pivotal trial, the device demonstrated similar bridge-to-transplant success rates with competing devices, MedPage Today explains.
Not to be forgotten: FDA approval gives HeartWare access to a significant market. In the U.S. alone, the ventricular pump market could surpass $750 million by 2015, Canaccord Adams analyst Jason Mills told Bloomberg.
- here's the Bloomberg story
- check out Reuters' coverage
- consider Forbes' take
- read MedPage Today's account