TIOGA CARDIOVASCULAR ANNOUNCES FIRST-IN-HUMAN CASES WITH ITS LUNA™ TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) SYSTEM

LOS GATOS, Calif., Oct. 23, 2024 /PRNewswire/ --  Tioga Cardiovascular, Inc., a Shifamed portfolio company, announced today the first-in-human trans-septal implantations using the 28 Fr. (French) Luna™ transcatheter mitral valve replacement (TMVR) system. The first patients achieved excellent hemodynamics post-procedure. The initial cases were performed with Adrian Ebner, MD in Asuncion, Paraguay and Irakli Gogorishvili, MD in Tbilisi, Republic of Georgia, with support from leading US physicians including: Azeem Latib, MD, Susheel Kodali, MD, Edwin C.W. Ho, MD, Gagan Singh, MD, MS, and Vinnie Bapat, MD.  

"Mitral valve interventions are inherently more complicated than other valve interventions due to the anatomical and functional complexities of the mitral valve, including the proximity to the LVOT (left ventricular outflow tract) and large annular sizes.  This has made developing safe and effective transcatheter TMVR solutions extremely challenging," commented Dr. Latib of Montefiore Medical Center, New York. "The Luna TMVR system is designed to address many of these challenges and it's exciting to bring this next-generation system into clinical use."

"This is an exciting milestone for Tioga and we look forward to continued clinical cases with our Luna TMVR system," stated Mike Dineen, President and Chief Executive Officer, Tioga Cardiovascular. "I would like to thank our clinical investigators and their teams for their commitment to clinical excellence in the initial cases of the Luna system. We look forward to sharing additional details about the Luna TMVR system at TCT next week."

The Luna TMVR system will be featured during the "Innovations in Transcatheter Mitral Valve Replacement Technologies" session on Tuesday, October 29 during the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC.

About Tioga Cardiovascular, Inc. 
Tioga Cardiovascular, a privately held portfolio company of Shifamed LLC, is focused on providing elegant valve replacement solutions for mitral applications that are procedurally simpler and use a less invasive, transcatheter approach. Visit www.tiogamed.com to learn more.

About Shifamed, LLC. 
Founded by serial entrepreneur Amr Salahieh, Shifamed LLC is a highly specialized medical innovation hub focused on developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.

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SOURCE Tioga Cardiovascular, Inc.