Tendyne Announces First Patient Enrolled in US Trans-Catheter Mitral Valve Replacement Trial
Tendyne Holdings, Inc. ("Tendyne") a privately held clinical stage medical device company, announced today the Tendyne Bioprosthetic Mitral Valve was successfully implanted in the first patient in the United States as part of a multi-center global feasibility study that aims to provide early insights into the safety and performance of the Tendyne Bioprosthetic Mitral Valve System in patients with symptomatic mitral regurgitation of degenerative or functional etiology.
Tendyne is developing a replacement tissue valve for the treatment of advanced mitral regurgitation that can
be placed into a beating heart without the use of cardio-pulmonary bypass. Among other novel attributes, the Tendyne device will be designed to have a “one size fits all” inner valve that manages the blood flow between
the left atrium and the left ventricle together with an outer frame that conforms to the native mitral valve orifice.
Tendyne will also have a suite of delivery tools that will be designed to enable the physician to tailor the clinical outcome to the patient. For example, during the course of the procedure if the physician perceives any paravalvular leak, the physician will be able to retract, re-position or redeploy the Tendyne device to optimize
its placement prior to locking it into place. The physician will also have the option of completely retrieving the valve at anytime during the procedure. This is intended to allow the use of alternative valve sizes in the initial valve selected does not perform to the physician’s satisfaction.
©2014 Tendyne Holdings, Inc.
Tendyne’s products are not approved for investigational use or sale in the United States.