Jean Boulle Group announces first US clinical trial implant of Tendyne transcatheter mitral valve


Boulle Medtech, a Jean Boulle Group medical technology company and the founding investor of Tendyne Holdings, has announced that the Tendyne transcatheter mitral valve implant was successfully implanted in the first patient in the USA. This follows successful implants in Great Britain and Australia in December 2014.

The US implant joins the other sites as part of a multicentre global feasibility study on the safety and performance of the Tendyne Valve in patients with symptomatic mitral regurgitation of degenerative or functional aetiology, some of whose condition would otherwise have been inoperable.

The procedure was performed at Minneapolis’s Abbott Northwestern Hospital in partnership with the Minneapolis Heart Institute Foundation. The surgical team consisted of Wesley Pederson (interventional cardiologist) and Saeid Farivar (cardiothoracic surgeon) assisted by Paul Sorajja, Benjamin Sun, and Richard Bae. The patient was discharged a few days after the operation.

Shortly after the procedure Pederson said: “This first study implant has occurred, the participant is ready for discharge and we couldn’t be more thrilled.” He added that the implant was simple and straightforward, the patient did well, and the successful implantation was a milestone marking the beginning of a new era of transcatheter valve replacement for patients with malfunctioning mitral valves. Pederson also commented that if proven efficacious, the Tendyne Valve may be an option for patients with diseased, damaged or malfunctioning mitral valves who are not deemed candidates for conventional surgery.

A company press release reports that the Tendyne Mitral Valve is designed to give physicians total control during the procedure with a device that is fully repositionable and retrievable, allowing the surgeon to see the outcome before the procedure is closed. In addition, the Tendyne Valve is made in multiple sizes so that the physician can select the size that best fits the patient’s specific anatomy. The valve is comprised of a tri-leaflet porcine pericardial valve sewn onto a nitinol frame that is tethered to the apex of the heart.