Tioga Cardiovascular, a Shifamed portfolio company, announced the first-in-human implants for its Luna TMVR system.
Luna, a 28 Fr. transcatheter mitral valve replacement (TMVR) system, features a unique valve and anchor design and utilizes nitinol. Los Gatos, California-based Tioga designed it to minimize patient exclusions and treat more patients with mitral regurgitation (MR).
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Dr. Adrian Ebner (Asuncion, Paraguay) and Dr. Irakli Gogorishvili (Tbilisi, Republic of Georgia) performed the initial cases. U.S. physicians Dr. Azeem Latib, Dr. Susheel Kodali, Dr. Edwin C.W. Ho, Dr. Gagan Singh and Dr. Vinnie Bapat offered support. The first patients achieved “excellent” hemodynamics post-procedure, according to a news release.
Latib said in the release that mitral valve interventions often prove more complicated than other valve interventions. This occurs because of the anatomical and functional complexities of the mitral valves, making TMVR development more challenging. According to Latib, Tioga designed Luna to address those challenges.
“This is an exciting milestone for Tioga and we look forward to continued clinical cases with our Luna TMVR system,” said Mike Dineen, president and CEO, 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.”
