Clinical Trial Result Validates That the Trinity TAVI System is Designed to Prevent Each of the Four Primary Causes of Paravalvular Regurgitation

“I look forward to meeting at EuroPCR with all those who want to learn more about our first clinical trial, which demonstrated that Trinity is designed to completely eliminate paravalvular leaks, which we believe is a game-changer for TAVI,” said cardiac surgeon and CEO of Transcatheter Technologies, Wolfgang Goetz, M.D. Dr. Wolfgang Goetz, can be contacted at (+49) 170 6309920 or at wolfgang.goetz@transcatheter-technologies.com.

REGENSBURG, Germany--()--Transcatheter Technologies GmbH, an emerging medical device company that has developed a full range of transcatheter valve implantation systems for catheter-based heart valve therapy, announced today that CEO Dr. Wolfgang Goetz will share the clinical trial result which demonstrated that the company’s Trinity TAVI systems are designed to prevent each of the four primary causes of paravalvular regurgitation. (Click here for animation.)

The TRINITY Transfemoral and Transapical Aortic Valve Implantation systems were developed by Dr. Goetz, a cardiac surgeon, who founded the company with the goal of making noninvasive heart valve implantation safer for patients, thus potentially expanding the number of patients who may benefit from a new heart valve.

Today, a major limitation of first-generation transcatheter-based heart valve implantation devices is that they cannot be repositioned once fully implanted. Consequently, even a slightly misplaced valve lacks a “tight fit”, thereby causing leakage in 1 out of 2 patients and the necessity for a pacemaker implant in 1 in of 4 patients. These events can be lethal, and certainly quality-of-life debilitating.

PROBLEM 1: Incomplete adherence of a valve to the annulus: 50% of TAVI cases. SOLUTION 1: Trinity is designed for strong adherence to the annulus because of the unique conformity of the stent and the webbed stent mesh.

PROBLEM 2: Low implant of a valve in 25% of TAVI cases. SOLUTION 2: ‘Low implant’ is designed to be a non-issue with Trinity because if the Trinity valve is implanted too low, the operator can reposition it at any time prior to completing the TAVI procedure.

PROBLEM 3: In nearly 17% of TAVI cases, the valve used is undersized, creating an annulus/prosthesis mismatch. SOLUTION 3: Trinity is designed to preclude the use an undersized valve, because the Trinity valve can be retrieved and replaced at any time prior to completing the TAVI procedure.

PROBLEM 4: High implant of a valve in more than 8% of TAVI cases. SOLUTION 4: ‘High implant’ is designed to be a non-issue with Trinity, because if the Trinity valve is implanted too high, the operator can reposition it at any time prior to completing the TAVI procedure. Additionally, Trinity is designed to be implanted high above the plane of the aortic annulus in order to avoid damage to the conduction system of the heart.

About Transcatheter Technologies GmbH
Transcatheter Technologies GmbH is a privately held medical device company headquartered in Regensburg, Germany. The company is developing a range of products for the treatment of structural heart diseases and valve disorders. For more Information visit: www.transcather-technologies.com.

CAUTION: The Trinity system is not approved for sale or investigational use in the U.S.

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

Release Summary

Clinical Trial Result Validates That the Trinity TAVI System is Designed to Prevent Each of the Four Primary Causes of Paravalvular Regurgitation

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108