CardioMech yesterday confirmed the completion of the first procedure with its transcatheter mitral valve repair (TMVR) technology.
The patient, diagnosed with severe symptomatic degenerative mitral regurgitation (DMR) was evaluated by Sanger Heart & Vascular Institute’s multidisciplinary heart team and offered a choice between open-heart surgery (the standard of care) or the new, investigational CardioMech MVRS, according to a report from Atrium Health.
Minneapolis-based CardioMech’s transcatheter transseptal chordal mitral valve repair technology is currently enrolling in an FDA investigational device exemption (IDE)-approved early feasibility study and is not yet commercially available in the U.S. or anywhere else around the globe.
The procedure was conducted in early September 2021, marking the first time the CardioMech MVRS technology had been used in a human
“For over a decade, we’ve been a leader and innovator in transcatheter mitral valve therapies,” interventional cardiologist & Medical Director of Sanger’s Structureal Heart Program Dr. Michael Rinaldi said. “This was such an exciting opportunity to be part of the very first human clinical trial of a technology that may prove to be an alternative therapy to other therapies we’ve worked with and developed.”
CardioMech designed its catheter-based mitral valve repair technology to treat patients suffering from moderate to severe or severe, symptomatic DMR due to prolapse or flail, providing therapy for the placement of artificial chords to reduce or eliminate MR.
The procedure implants artificial chords with anchors on each end — one for the mitral valve leaflet and the other for the left ventricle wall — with the artificial chords then adjusted on a beating heart to reduce or eliminate the regurgitation.
“This procedure allows the surgeon to pull the floppy mitral leaflet down in real-time, while the valve is opening and closing, attempting to bring the valve back to its natural form,” Rinaldi said. “If the procedure doesn’t work, “the surgeon can simply repair the valve surgically or add a catheter-based clip to further minimize leaking.”
Rinaldi noted that the procedure was “a complete win” and a clinical success, taking the mitral valve leak from severe to mild. The patient returned home the next day.
“When we’re caring for patients, we don’t want to just offer good care; we want to offer the best science-based medicine available,” Rinaldi said. “Our goal is to provide the latest techniques and technology to our patients. That’s why we’re continuing to pioneer these technologies through clinical trials.”