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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The human heart is responsible for the pumping of blood around the human body. The human heart is separated into four distinct chambers, and is commonly referenced in terms of the right or left side of the heart.  The left side of the heart, incorporating the left atrium and left ventricle, is responsible for receiving freshly oxygenated blood from the lungs, and then pumping that blood around the body. The right side of the heart, incorporating the right atrium and the right ventricle, is responsible for receiving de-oxygenated blood, and then pumping that blood to the lungs in order to restart the circulatory process.

The movement of blood within the chambers of the heart is controlled by four valves: aortic, mitral, pulmonic
and tricuspid. These valves open and close constantly and, like all apparatuses, ultimately can be subject to “wear and tear” and other challenges that effect their performance (and ultimately the performance of the
entire circulatory system).

In certain circumstances, the performance of the mitral valve may be eroded to such an extent that a replacement or prosthetic valve may need to be implanted in order to restore normal functionality within
the heart. Traditionally, mitral valve replacement has been via open-heart surgery.

Tendyne is focused on the delivery of a mitral valve without the need for open-heart surgery.

 

 

©2014 Tendyne Holdings, Inc.

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