Pi-Cardia Receives FDA Market Clearance for ShortCut™

First dedicated leaflet modification device to enable TAVR in patients at risk of coronary obstruction

REHOVOT, ISRAEL / BUSINESSWIRE / SEPTEMBER 30, 2024 /

Pi-Cardia Ltd., a global leader in the development of leaflet modification solutions for treating heart valves, announced today that the United States Food and Drug Administration (FDA) provided market clearance for ShortCut™ - the world's first dedicated leaflet modification device, enabling valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.

“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,” said Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center and professor of medicine at the Columbia University College of Physicians and Surgeons, who chairs the global steering committee for ShortCut™ studies. “The rigorous pivotal study leading to this important market clearance by the FDA demonstrates that ShortCut™ was both safe and effective in achieving the intended leaflet split in all patients. Importantly – it also shows that mechanical splitting with ShortCut™, in both single- and dual-leaflet cases, was a controlled and teachable procedure, making it adoptable by TAVR centers as a critical step pre-implantation, so that patients at risk of coronary obstruction may be safely treated, without disruption of TAVR workflow.”

TAVR has become the preferred treatment for aortic stenosis, recently surpassing surgery even in patients younger than 65.1 As bioprosthetic valves degenerate over time, these patients will at some point likely need a valve-in-valve procedure to be performed, and a significant portion of them who are at risk for coronary obstruction will require leaflet splitting with ShortCut™. Recent models published by Philippe Généreux, MD, from Morristown Medical Center, New Jersey, predict that by 2035, more than 42,000 valve-in-valve procedures will be performed annually in the U.S., representing ∼15% of all TAVR procedures.2 Future planned indication expansion into native and bicuspid valves may mean that around 30% of future TAVR cases will require leaflet modification with ShortCut™ in order to be performed safely and obtain optimal results for patients.

"We are excited and immensely proud to introduce the first dedicated leaflet modification device to the US market," said Erez Golan, Chief Executive Officer of Pi-Cardia. “With FDA clearance now in hand, we are focused on building a strong commercial and clinical support team to execute a limited commercial launch while ensuring optimal patient outcomes. Building on the breakthrough device designation awarded to ShortCut™ earlier this year, we are committed to collaborating closely with our physician and hospital system partners to ensure they have access to this unique enabling device. ShortCut™ clearance by the FDA opens a new era in the lifetime management of patients with aortic stenosis."

About Pi-Cardia

ShortCut™ Mitral is designed to split the anterior mitral leaflet prior to TMVR in patients at risk for LVOT obstruction. The Leaflex™ device mechanically scores valve calcification at multiple locations, with the intention of restoring leaflet flexibility and improving valve hemodynamics. Leaflex™ is designed to be a cost-effective, durable standalone treatment for patients with calcified aortic stenosis. Additional leaflet modification technologies are being developed to further expand treatment options in challenging anatomies such as bicuspid valves. The Leaflex™ and ShortCut™ Mitral are investigational devices, limited by United States law for investigational use.

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

For further information, contact:

Erez Golan

CEO

erez@pi-cardia.net

Eyal Kolka

Executive Director

eyal@pi-cardia.net

SOURCE: Pi-Cardia Ltd.

References

• O'Riordan, Michael. TCTMD, June 2024.
• Généreux, Philippe., et al. Structural Heart Journal, June 2024.