MassDevice Q & A: Claret Medical ’ s Azin Parhizgar on trying to make TAVR safer

Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism. The device has seen a rough road to approval, however, after missing the primary efficacy endpoint in its pivotal trial. Despite that, the device saw nearly unanimous support from an FDA advisory panel and was cleared by agency. The clearance is the 1st for such a device from the FDA, according to CEO Azin Parhizgar, who spoke to MassDevice.com about what the approval means, and what’s next for the cerebral protection developer. Below, edited for clarity, is a transcript of our conversation. MassDevice: You’ve won FDA De Novo clearance for your Sentinel TAVR filter – what does that mean for your team and Claret and where will you go next? Azin: With any new technology, you target your markets. You have a cadence in terms of going to market, especially in the healthcare space. You have regulatory boundaries around you, and you work to clear them efficiently. One of the biggest markets in the world is the US market, so being cleared in the US market opens up a large opportunity for the company, and for the technology. It validates the use and beneficial eff...
Source: Mass Device - Category: Medical Devices Authors: Tags: Neurological Surgical Vascular Claret Medical Inc. Source Type: news