Ventura County to enroll patient in groundbreaking clinical trial

Los Robles Health System is the first hospital in Ventura County to enroll a patient in a groundbreaking Pi-Cardia ShortCut™ device clinical trial. It is the first dedicated device to enable coronary access and prevent coronary obstruction during transcatheter aortic valve replacement (TAVR). This new technology can help a significant number of patients that undergo a second valve implantation and can potentially enhance the safety of valve-in-valve procedures.

The device is designed to provide a safe and effective means of splitting either one or two leaflets of a pre-existing valve prior to a TAVR procedure — while enabling coronary access and preventing coronary obstruction during transcatheter aortic valve implantation (TAVI). The device allows complete control over positioning and leaflet splitting location.

The Shortcut study is currently ongoing in the United States, Europe and Israel. Patients who present for a valve-in-valve (ViV) TAVR procedure with approved ViV indication and are at risk for TAVR-induced coronary artery ostium obstruction would qualify for the Shortcut procedure.

On Thursday, June 22nd, the successful treatment of the first patient enrolled at Los Robles with the Pi-Cardia ShortCut™ device was performed by Los Robles Health System’s Dr. Saibal Kar and Dr. Gregory Fontana.