
Tioga Cardiovascular, a Shifamed portfolio company, has announced the first-in-human transseptal implantations using the 28 Fr Luna transcatheter mitral valve replacement (TMVR) system.
The first patients achieved excellent haemodynamics post-procedure, the company said in a press release. The initial cases were performed with Adrian Ebner in Asuncion, Paraguay and Irakli Gogorishvili in Tbilisi, Republic of Georgia, with support from physicians including: Azeem Latib, Susheel Kodali, Edwin CW Ho, Gagan Singh and Vinnie Bapat.
“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 Latib of Montefiore Medical Center, New York, USA. “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 29 October during the Transcatheter Cardiovascular Therapeutics (TCT) conference (27–30 October, Washington, DC).