Edwards Lifesciences ($EW) can commence with a human clinical clinical trial of its GLX-next generation heart tissue treatment tech. The company disclosed that the FDA granted a crucial investigational device exemption that will allow it to proceed.
The technology just obtained its CE mark in May, so it is much further behind in the U.S. regulatory approval process. Essentially, it is a tissue treatment designed to help better protect a surgical bovine pericardial heart valve, preventing calcification of the bovine pericardial tissue so the valve lasts longer. Also, the treatment allows the valve to be packaged and sterilized dry, so it doesn't need to be rinsed before doctors do the implant.
At first, Edwards plans to test the technology with its Carpentier-Edwards PERIMOUNT Magna Ease Aortic Valve, though others might be added later on. Expectations are that Edwards will enroll between 500 and 700 patients to test the safety and effectiveness of valves using the new technology.
Separately, the company continues to advance its transcatheter heart valve business, having recently obtained crucial CMS reimbursement approval when its new Sapien transcatheter heart valve is used in transcatheter aortic valve replacement surgery to treat symptomatic aortic valve stenosis.
- read the release