Tioga’s Luna TMVR System Used in FIH Procedures

October 23, 2024—Tioga Cardiovascular, Inc., a Shifamed portfolio company, announced the first-in-human (FIH) transseptal implantations using the company’s 28-F Luna transcatheter mitral valve replacement (TMVR) system.

According to the company, the first patients treated with the Luna TMVR system achieved excellent hemodynamics postprocedure.

Tioga reported that the initial procedures were performed by Adrian Ebner, MD, in Asuncion, Paraguay, and by Irakli Gogorishvili, MD, in Tbilisi, Republic of Georgia, with support from leading structural heart experts from the United States, including Azeem Latib, MD; Susheel Kodali, MD; Edwin C.W. Ho, MD; Gagan Singh, MD; 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 left ventricular outflow tract and large annular sizes,” commented Dr. Latib in Tioga’s press release. “This has made developing safe and effective transcatheter TMVR solutions extremely challenging.”

Dr. Latib, who is from Montefiore Medical Center in New York, New York, continued, “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.”

The company advised that the Luna TMVR system will be featured during the “Innovations in Transcatheter Mitral Valve Replacement Technologies” session on October 29 at TCT 2024, the Transcatheter Cardiovascular Therapeutics conference held October 27-30 in Washington, DC.