Is this the “World’s Best Repositionable Heart Valve”?

Transcatheter Therapeutics 2013 starts this weekend, so its not altogether surprising, to cynical old hacks at least, to see companies rushing to make sure we know what they’re up to. German transcatheter aortic valve developer (the clue’s in the name) Transcatheter Technologies GmbH, has announced the successful first-in-human implantation of its transapical TRINITY aortic valve.

Background

Founded in 2009, Transcatheter Technologies GmbH has come up with its own take on transcatheter aortic valve design. The TRINITY aortic valve prosthesis is comprised of a bovine pericardium valve with porcine pericardium-sealing cuff that is mounted on a self-expanding Nitinol frame. The TRINITY aortic valve prosthesis is pre-mounted on a detachable catheter tip. TRINITY’s unique features enable controlled positioning and true repositioning without foreshortening. The valve prosthesis is protected during folding of the stent. This Zero Pressure Crimping™ is expected to improve valve durability and broaden the application of transcatheter valve implantations across a larger patient population.

The result of all this clever stuff is that the company is modestly claiming its device is designed to be the “world’s best repositionable heart valve.”

Now, we know a few companies who might challenge that claim, but it certainly seems that the TRINITY device has some neat features, not least its ability to undergo full functional assessment with subsequent retrieval or repositioning as required.

The results of the first-in-human clinical trial using Trinity will be presented at the annual TCT Meeting in San Francisco on Monday, October 28, 2013. Miraculously only a weekend after the press release about its first implantation was issued. That’s good timing for you.

Physician comments

“The TRINITY aortic valve can be positioned precisely. Yet, it also allows for safe repositioning of the valve prosthesis—or even full retrieval—if necessary. Its unique sealing cuff provides excellent results without paravalvular leakage. Moreover, the risk for atrio-ventricular block is dramatically reduced due to the supraannular positioning of TRINITY,” added Prof. Christian Hengstenberg, cardiologist at the German Heart Center in Munich.

Company comments

“A major limitation of existing transcatheter aortic heart valves is that they cannot be repositioned once implanted. Trinity, however, is designed to solve this difficult problem,” said Wolfgang Goetz, MD, PhD, CEO, a cardiac surgeon by training. “With Trinity, once our valve is initially placed, a cardiologist can fully evaluate the valve’s function to determine whether it needs to be repositioned, retrieved, or kept in the same position. Equally important, Trinity provides for a controlled positioning by allowing a cardiologist to slowly open the valve stent, thus improving the likelihood of a first-attempt correct placement.”

Source: Transcatheter Technologies GmbH, Business Wire