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.

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Tendyne focuses on the mitral valve where common pathologies include:

(a) Stenosis: a form of calcification leading to a narrowing or stiffening of the valve that prevents the adequate flow of blood supply.

(b) Regurgitation: when deformation of valve leaflets is such that the valve doesn’t close completely and thereby allows blood to leak back (regurgitate) from the lower chamber to the upper chamber.
Mitral regurgitation can be caused by many different valve disorders including prolapsed valve
leaflets, restricted valve leaflets, a dilated annulus, among other diseases.

Mitral regurgitation is generally categorized in one of the following two ways:

• “Degenerative mitral regurgitation” is associated with mitral valve prolapse and flail.

• “Functional mitral regurgitation” captures regurgitation caused by dilation of the left ventricle (caused by,

for example, heart attack or various cardiomyopathies) pulling apart the mitral apparatus.

 

 

©2014 Tendyne Holdings, Inc.

Tendyne’s products are not approved for investigational use or sale in the United States.