The US FDA Grants Breakthrough Device Designation to Pi-Cardia’s ShortCut
Shots:
- The US FDA has granted Breakthrough Device Designation to Pi-Cardia’s ShortCut device enabling valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) methods in patients with the risk of coronary obstruction
- ShortCut, Pi-Cardia's leaflet modification product, consists of ShortCut Mitral designed to split leaflets in patients at risk for left ventricular outflow tract obstruction post Transcatheter Mitral Valve Replacement (TMVR)
- Additionally, the portfolio includes Leaflex, a standalone mechanical scoring device that restores leaflet mobility and improves hemodynamics in patients with aortic stenosis. Leaflex global clinical studies are ongoing
Ref: Businesswire | Image: Pi-Cardia
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
