UPDATED May 17, 2013 with comment from Tryton CEO Shawn McCarthy.
Tryton Medical said it got the green light in Europe for its side-branch short coronary stent to treat bifurcation lesions in large vessels.
The new stent is 15mm, 3mm shorter in the main branch zone than the standard Tryton side-branch stent, the Durham, N.C.-based medical device company said.
Tryton said it’s planning an immediate launch of the device in CE Mark countries starting next week at the annual EuroPCR meeting in Paris, according to a press release.
President & CEO Shawn McCarthy told MassDevice.com that the company hopes to present data from its U.S. trial of the original Tryton side-branch stent at the annual Transcatheter Cardiovascular Therapeutics conference in October, ahead of a pre-market approval application.
"We expect to have the data presented at TCT in October and we expect to submit to FDA by end of year, which would give us an expected approval in 2014," McCarthy told us.
There are an estimated 3 million percutaneous coronary interventions each year, he said, with about ⅓ involving birfurcated lesions, which is Tryton’s sweet spot.
"The world of stenting is known very well, but it really is for very straightforward lesions. Our effort is to bring to our physicians the same level of confidence and control for the bifurcations and more complex lesions. The organization is built for bifurcations – we’re completely focused on that space. We are the 1st IDE-approved approved by the FDA in bifurcation with a dedicated stent. My guess is that we have a 2-to-3-year lead on anyone else. There are no other approved IDEs we’re aware of."
Tryton’s side-branch cobalt chromium stents are built for bifurcation using the company’s Tri-Zone technology, the company said. The stents are deployed in the side-branch artery using a standard single-wire balloon-expandable stent delivery system. Then, a conventional drug-eluting stent is placed in the main vessel.
Dr. Joanna Wykrzykowska of the Academic Medical Center, University of Amsterdam, Netherlands completed the first implant of the Tryton side-branch short Stent and touted the stent in a press statement for the "control" it gives her in stenting patients "whose anatomy in the main branch makes it challenging to deliver a longer size stent."
"The Tryton side-branch short Stent may be particularly helpful when treating disease in the left main artery," Wykrzykowska continued. "Left main coronary artery disease has historically been challenging to address interventionally, but this new stent provides confidence I can deliver it where it needs to go and ensure both the main branch and side-branch openings receive optimum scaffolding and support."
Left main disease, an accumulation of plaque that narrows the base of the coronary tree, is a persistent challenge in interventional cardiology, as more than 75% of left main lesions are bifurcation lesions. Tryton’s side-branch stent has not been studied extensively in left main disease, the company noted.
Tryton’s side-branch stent is an investigational device in the U.S. The company said it has completed enrollment in the first and only randomized controlled U.S. IDE pivotal clinical trial evaluating a dedicated bifurcation stent and expects to present study outcomes in October at the annual TCT meeting in San Francisco.