ShortCut is the first dedicated leaflet modification device to enable TAVR in patients at risk of coronary obstruction.
The US Food and Drug Administration (FDA) granted Breakthrough Device Designation to Pi-Cardia’s ShortCut, a dedicated leaflet modification device facilitating valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction.
This announcement comes after the completion of enrollment in the ShortCut pivotal study in the US and Europe in September 2023.
ShortCut is part of Pi-Cardia’s leaflet modification product portfolio, which includes the ShortCut Mitral for splitting leaflets in patients at risk for left ventricular outflow tract obstruction following TMVR, and Leaflex, a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and improve hemodynamics for patients with aortic stenosis. Leaflex global clinical trials are underway.
“Having been part of Pi-Cardia’s rigorous clinical program, I am thrilled to see the recognition in the importance of ShortCut,” says Philippe Genereux, MD, Morristown Medical Center, in a release. “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 center as a critical step pre-implantation so that patients at risk of coronary obstruction will be safely treated without disruption of TAVR work-flow.”
Erez Golan, Pi-Cardia’s CEO, says in a release, “We are excited to receive this important recognition by the FDA. Breakthrough Device Designation is only awarded to technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly 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 ShortCut device and Leaflex device are investigational devices, limited by United States law for investigational use.