The implantations were performed by physicians from Paraguay and Republic of Georgi along with a team of US doctors. Credit: Tioga Cardiovascular. Inc/ PR Newswire.

Medical device company Tioga Cardiovascular has achieved its first-in-human trans-septal implantations using the 28 Fr Luna transcatheter mitral valve replacement (TMVR) system.

The procedures are claimed to have resulted in ‘excellent’ haemodynamics for the initial patients post-operation.

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The cases were carried out in Paraguay and the Republic of Georgia. These were undertaken by physicians Adrian Ebner of Asuncion, Paraguay; and Irakli Gogorishvili of Tbilisi, Republic of Georgia, along with support from a team of US physicians.

Mitral valve interventions pose significant challenges due to the anatomical and functional complexities of the mitral valve.

These complexities include its proximity to the left ventricular outflow tract (LVOT) and large annular sizes.

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Consequently, developing effective and safe transcatheter TMVR solutions has been extremely challenging.

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According to Dr Latib of Montefiore Medical Center, New York, the Luna TMVR system is designed to address many of these challenges.

Tioga Cardiovascular president and CEO Mike Dineen said: “This is an exciting milestone for Tioga, and we look forward to continued clinical cases with our Luna TMVR system.

“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 showcased during the ‘Innovations in Transcatheter Mitral Valve Replacement Technologies’ session at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference.

The event is scheduled for 29 October in Washington, DC.