Pi-Cardia, developer of leaflet modification solutions for treating heart valves, today announced it has received FDA Breakthrough Device Designation for ShortCut, a leaflet modification device used for valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction.
The catheter is designed to provide a safe, simple, and effective way to split valve leaflets prior to TAVR and enables complete control over positioning and location of splitting, according to the company, which also noted that the device is the first to be dedicated to leaflet modification to enable TAVR in patients with a risk of coronary obstruction.
“We are excited to receive this important recognition by the FDA,” said Erez Golan, CEO of Pi-Cardia, in the press release announcing the designation. “Breakthrough Device Designation is only awarded to technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversible debilitating diseases or conditions, and it may help accelerate our review process with the FDA this year and bring ShortCut to market for the benefit of patients.”
The catheter is part of the company’s leaflet modification portfolio which also includes the ShortCut Mitral and Leaflex. The ShortCut Mitral is designed for splitting leaflets in patients at risk of left ventricular outflow tract obstruction following TAVR. Leaflex is a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and improve hemodynamics for patients with aortic stenosis.
Pi-Cardia completed enrollment of its ShortCut pivotal study in the US and Europe in September of last year. Leaflex global clinical trials are also underway.
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