Eerste speciale apparaat om coronaire toegang mogelijk te maken en coronaire obstructie te voorkomen tijdens transkatheter-aortaklepvervanging

REHOVOT, Israël– (BUSINESS WIRE) – Pi-Cardia Ltd., een wereldleider in de ontwikkeling van niet-implanteerbare, katheter gebaseerde oplossingen voor de behandeling van hartkleppen, kondigde vandaag succesvolle first-in-human procedures aan met zijn ShortCut™ -apparaat. ShortCut™ is ‘s werelds eerste speciale apparaat dat is ontworpen om de bladen van een reeds bestaande klep te splitsen om een ​​veilige Transcatheter Aortic Valve Replacement (TAVR) mogelijk te maken bij patiënten met een risico op coronaire obstructie of gecompromitteerde coronaire toegang.

De TAVR-markt, momenteel geschat op $ 5 miljard, zal naar verwachting in de komende vijf jaar verdubbelen, met de uitbreiding naar jongere patiënten met een laag risico. Deze groei kan echter worden belemmerd door een fundamentele uitdaging: tijdens de TAVR-implantatie worden de bladen van de reeds bestaande klep zijwaarts geduwd, op een manier die toekomstige coronaire toegang bij veel patiënten in gevaar kan brengen. Dit kan een levensbedreigende complicatie worden van volledige coronaire obstructie bij een aanzienlijk aantal patiënten die een tweede klepimplantatie ondergaan wanneer hun vorige bioprothetische klep degenereert. ShortCut™ kan in beide situaties worden gebruikt om de reeds bestaande klepbladen te splitsen om toekomstige coronaire interventie mogelijk te maken en coronaire obstructie te voorkomen.

Pi-Cardia Successfully Treats First Patients with ShortCut™ Device

First Dedicated Device to Enable Coronary Access and Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement

REHOVOT, Israel–(BUSINESS WIRE)– Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based solutions for treating heart valves, announced today successful first-in-human procedures with its ShortCut™ device. ShortCut™ is the world’s first dedicated device designed to split the leaflets of a pre-existing valve to enable safe Transcatheter Aortic Valve Replacement (TAVR) in patients at risk for coronary obstruction or compromised coronary access.

The TAVR market, currently estimated at $5 billion, is predicted to double over the next five years, with the expansion into low-risk younger patients. However, this growth may be hindered by a fundamental challenge: During TAVR implantation, the leaflets of the pre-existing valve are pushed sideways, in a way which may compromise future coronary access in many patients. This can turn into a life-threatening complication of complete coronary obstruction in a significant number of the patients who undergo a second valve implantation when their previous bio-prosthetic valve degenerates. ShortCut™ may be used in both situations to split the pre-existing valve leaflets to enable future coronary intervention and prevent coronary obstruction.

The first ShortCut™ procedures performed in Shaare Zedek Medical Center in Jerusalem, Israel, by Dr. Danny Dvir – a leading expert in the field, who was the first to perform BASILICA procedures to prevent coronary obstruction in TAVR. “Using ShortCut™ we were able to treat two extremely complex patients with degenerated valves that needed a solution to prevent coronary obstruction after TAVR. In both patients we were able to effectively split the leaflets within minutes, allowing for a safe implantation of both self-expanding and balloon expandable TAVR valves,” said Dr. Dvir. “ShortCut™ addresses an unmet need for a simple tool to prevent coronary obstruction, which I strongly believe can easily be adopted by all TAVR centers. I can also see ShortCut™ being used to prepare bicuspid valves in selected cases, by splitting the fused leaflets or tri-cuspidizing the bicuspid valves, enabling an optimal TAVR result in this patient population.”

ShortCut™ is the latest addition to Pi-Cardia’s product offering, which includes the Leaflex™ device – a standalone, non-implant-based treatment for patients with aortic stenosis. Leaflex™ performs mechanical scoring of valve calcification, in order to restore leaflet mobility and improve hemodynamics. Clinical trials are underway in the US, Europe, and China.

“We are very excited about this key milestone of demonstrating clinical feasibility with ShortCut™, which allows us to move forward with our clinical plan in the US and Europe,” said Erez Golan, Pi-Cardia’s Chief Executive Officer. “As the number of patients with aortic stenosis continues to grow, both Shortcut™ and Leaflex™ may offer important new treatment options for both physicians and patients.”

About Pi-Cardia

Pi-Cardia is a global leader in the development of unique non-implant-based solutions for treating heart valves. Pi-Cardia’s lead product, the Leaflex™ device, is easily delivered and positioned on the valve, to then mechanically score the calcification at multiple locations, restoring leaflet flexibility and improving valve hemodynamics. The Leaflex™ device is designed to be a cost-effective, durable standalone treatment for patients with calcified aortic stenosis. Pi-Cardia’s second product, the ShortCut™ device, offers a safe, simple and effective way to split the leaflets of a pre-existing valve prior to TAVR in order to maintain coronary access in patients at risk for coronary obstruction or compromised coronary access.

For more information, please visit: www.pi-cardia.net

Contacts

Erez Golan

CEO

erez@pi-cardia.net
+972-8-8484800

Eyal Kolka

Executive Director

eyal@pi-cardia.net