Pi-Cardia has received breakthrough device designation from the US Food and Drug Administration (FDA) for the ShortCut leaflet modification device facilitating valve-in-valve transcatheter aortic valve implantation (TAVI) procedures in patients at risk of coronary obstruction.
The announcement comes after completion of enrolment in the ShortCut Pivotal study in the USA and Europe in September 2023.
“Having been part of Pi-Cardia’s rigorous clinical programme, I am thrilled to see the recognition in the importance of ShortCut,” said Philippe Genereux (Morristown Medical Center, USA). “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 TAVI centre as a critical step pre-implantation, so that patients at risk of coronary obstruction will be safely treated, without disruption of TAVI workflow.”
“We are excited to receive this important recognition by the FDA,” said Erez Golan, Pi-Cardia’s chief executive officer. “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.”
