Jean Boulle Group Reports Successful First Clinical Trial Implant of the Tendyne Transcatheter Mitral Valve

PR59064

LUXEMBOURG, Dec. 29 /PRN=KYODO JBN/ --

    Boulle Medtech Ltd, a Jean Boulle Group company focusing on medical

technology and a founding investor of Tendyne Holdings, Inc. ("Tendyne"), is

pleased to announce that the Tendyne Transcatheter Mitral Valve Implant (TMVI)

was successfully placed in the first patient enrolled in a three-continent,

multicenter trial being conducted as part of the Tendyne Feasibility Study. The

study is to generate insight into the safety and performance of the Tendyne

device in inoperable patients suffering from mitral regurgitation.

    Drs. David Muller and Paul Jansz performed the procedure at St. Vincent's

Hospital in Sydney, Australia. Tendyne reports that the device was implanted

transapically without cardiopulmonary bypass, performed as intended by

completely eliminating mitral regurgitation, and that the patient was released

from the hospital on day 5. Prior to this, the Tendyne device had been

successfully implanted in London in three other persons under a compassionate

use protocol in October and early November 2014 (see Boulle Medtech release of

December 10, 2014).

    The Tendyne TMVI is a fully retrievable and repositionable, apically

tethered tri-leaflet porcine pericardial valve sewn onto a Nitinol

(nickel/titanium) frame specifically designed to address the mitral anatomy of

functional, degenerative and mixed etiology mitral regurgitation. Left

untreated, mitral regurgitation can lead to heart failure and death.

    About Boulle Medtech Ltd.

    Boulle Medtech Ltd. is a Jean Boulle Group company focusing on medical

technology. Its holdings include Tendyne Holdings, Inc. Boulle Medtech is a

founding investor and major shareholder of Tendyne.

    About Tendyne Holdings, Inc.

    Tendyne Holdings, Inc is headquartered in Roseville, Minnesota and is a

privately-held, clinical stage medical device company developing a unique

Transcatheter Mitral Valve Implant (TMVI). Implanted in a beating heart in a

hybrid operating room, the Tendyne design has proprietary and patented features

that can treat a variety of mitral pathologies. With a less invasive approach

than open cardiac surgery, TMVI may result in similar outcomes with fewer

surgical complications.

    For more information about the Jean Boulle Group or Boulle Medtech, contact

Audrey Richardson at +352-222-512, audrey@jeanboullegroup.com, or go to our

website http://www.jeanboullegroup.com.

    For more information about Tendyne, go to http://www.tendyne.com.

SOURCE: Jean Boulle Group