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The US FDA Grants Breakthrough Device Designation to Pi-Cardia’s ShortCut

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The US FDA Grants Breakthrough Device Designation to Pi-Cardia’s ShortCut

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  • 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

Related News:- Medinol’s EluNIR-PERL Drug-Eluting Coronary Stent System Receives the US FDA’s Approval to Treat Coronary Artery Disease

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Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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