German medtech developer CoreMedic this week announced the launch of a first-in-man trial of its ChordArt mitral valve repair device, touting the trial as the first of its kind to treat patients with ruptured or elongated mitral chords.
The company’s ChordArt implant is designed to replace ruptured or elongated mitral chordae and to re-establish the connection of the valve leaflets with the papillary muscle to restore functionality. In the trial, researchers will explore the use of the system in up to 40 patients at six European centers, CoreMedic said.
“The first clinical use of ChordArt is a major milestone in our path towards developing the best in class transfemoral mitral valve chordal repair system,” CEO Thomas Bauer said in a prepared release.
“In 2017 we invested in CoreMedic to advance the development of ChordArt. We look forward to the results of clinical trials that will validate the applications of this breakthrough device,” SHS managing partner Hubertus Leonhardt said in a prepared statement.
The first patient in the trial has already been treated by Dr. Kęstutis Ručinskas at Lithuania’s Vilnius University Hospital. The patient has reportedly recovered “very well” from the intervention and has shown no signs of complications at a 30-day follow-up.
“Using the ChordArt reduced the invasiveness and duration of the procedure by repairing the valve in a fast, precise and safe way. This allowed the Heart Team to focus on the procedure and timing rather than manually placing the artificial chords to resolve the mitral insufficiency. Thanks to the ease of the ChordArt deployment technique, this was the fastest mitral valve chordal repair I have ever witnessed,” Dr. Alberto Weber of Zurich, Switzerland, who proctored the procedure, said in a press release.