Medtronic announced on 18 November 2010 the global launch and first clinical use of the Tri-Ad Semi-Flexible Tricuspid Annuloplasty Ring for the treatment of tricuspid valve disease. The ring is designed to adapt to the movement of a diseased patient’s natural valve to help restore the valve to its normal size and shape. The Tri-Ad ring recently received clearance for use in the USA and Europe, expanding Medtronic’s surgical heart valve repair product portfolio.
Tricuspid dilatation is a progressive disease that eventually leads to severe tricuspid regurgitation (TR), which occurs when the tricuspid valve leaflets do not close properly, allowing blood to flow opposite of the intended direction. For patients with significant dilation of the tricuspid annulus (or opening), surgeons typically recommend surgical repair with an annuloplasty ring or band to provide support and relieve stress on the native annulus, where the valve can be stretched and leaking.
“Our understanding of the complex 3-dimensional nature of the tricuspid valve has progressed over the past several years due to advances in imaging. We have translated this knowledge into a new concept that combines the characteristics of the currently available tricuspid rings, which up until now have been completely rigid or completely flexible,” said David H Adams, chairman of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center and lead developer of the Tri-Ad ring. “The Tri-Ad ring has a rigid component to correct the main lesion seen in tricuspid regurgitation, in combination with completely flexible sections to protect delicate tissue.”
About the Tri-Ad Tricuspid Annuloplasty Ring
The Tri-Ad Semi-Flexible Tricuspid Annuloplasty Ring, acquired when Medtronic purchased ATS Medical, is an implantable annular ring that is part flexible and part semi-rigid. It is designed to correct the dilated and leaking portion of the valve, thereby preserving the natural motion of the heart as it beats. It received CE mark and FDA clearance in July 2010.
David Fullerton, of the University of Denver in Colorado, who implanted one of the first Tri-Ad rings said, “The Tri-Ad tricuspid valve ring is a significant advance in the treatment of tricuspid valve disease. Its unique design re-establishes the normal anatomy of the tricuspid valve annulus. The ring is stiff in exactly the proper position, and the flexible segments distinguish the ring from any of the available tricuspid rings. It will change the way therapy is delivered to the tricuspid valve.”
“The Tri-Ad Semi-Flexible Tricuspid Ring is an important addition to Medtronic’s tricuspid valve repair product portfolio, which includes three other flexible annuloplasty products,” explained Robert Perry, vice president of Surgical Based Therapies for the Medtronic Structural Heart business. “Medtronic now has the most complete heart tricuspid valve repair product portfolio for cardiac surgeons, which was made possible in part by our acquisition of ATS Medical. We look forward to introducing additional future surgical repair solutions to improve clinical outcomes.”