Israeli medical device start-up Pi-Cardia has received breakthrough device designation from the US Food and Drug Administration (FDA) for its ShortCut leaflet modification device.
ShortCut is intended to ease valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients who are at risk of coronary obstruction.
The device is claimed to be the world’s first dedicated device to offer a safe, simple and effective way to split valve leaflets.
The latest announcement follows the completion of enrolment in the US and Europe for the ShortCut pivotal study in September last year.
The device is part of Pi-Cardia’s leaflet modification product portfolio which already includes ShortCut Mitral and Leaflex.
Pi-Cardia CEO Erez Golan said: “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.”
ShortCut Mitral is designed to split anterior mitral leaflets in patients at risk for left ventricular outflow tract obstruction after TMVR.
On the other hand, Leaflex is a stand-alone, non-implant-based mechanical scoring device for patients with calcified aortic stenosis.
It aims to improve valve hemodynamics and restore leaflet flexibility by manually scoring valve calcification at numerous sites. The global clinical trials for Leaflex are currently ongoing.
Morristown Medical Center MD Philippe Genereux said: “Lifetime management of aortic stenosis calls for leaflet modification solutions like ShortCut to ensure that we are carefully addressing the risk of coronary obstruction before implanting a valve.
“From what we have seen regarding the ability to easily teach and perform the procedure, ShortCut could be easily adopted by every TAVR centre as a critical step pre-implantation, so that patients at risk of coronary obstruction will be safely treated, without disruption of TAVR work-flow.”
The medical device company is also developing more leaflet modification technologies to increase treatment choices in difficult anatomy like bicuspid valves.
