Transcatheter Technologies GmbH touted 6-month results from a pilot study of its Trinity transcatheter aortic valve implantation system, reporting no instances of valve leakage.
Paravalvular leakage is an important indicator of mortality risk in TAVI procedures. Early generations of devices were marred with post-implantation leakage in the replacement valve and new technologies have taken steps to stem that risk.
The special sauce in Transcatheter Tech.’s TAVI system is that the valve is fully repositionable, even after complete deployment. A physician can fully implant the device, test its function and placement, and then retract the system and shift its position if necessary.
"Once our Trinity valve is completely expanded and anchored above the annulus, a cardiologist can then fully assess the valve’s function to determine whether it needs to be repositioned, retrieved, or kept in the same position," Transcatheter Tech. CEO and cardiac surgeon Dr. Wolfgang Goetz said in prepared remarks. "This feature is absolutely unique to Trinity, which is why we have positioned Trinity as a Third-Generation TAVI System."
The early study results look promising for the technology, which has some big players to contend with in the TAVI market. Medtech titans Edwards Lifesciences (NYSE:EW) and Medtronic (NYSE:MDT) have been vying for that market for years. The fight recently made its way to U.S. soil when Medtronic earlier this year won FDA approval for Medtronic’s CoreValve TAVI system.
If results from early studies of the Trinity valve continue in larger studies, Transcatheter Tech. may have some minor leverage over its much larger rivals. The pilot study reported no cases of AV-block and no need for new pacemaker implants, the company reported.
The so-called "pacemaker issue" has been a recurring topic at healthcare conferences since 1st publication last year in the Journal of the American College of Cardiology, although the problem isn’t considered a safety risk.
Leave a Reply
You must be logged in to post a comment.