Tryton Medical said it won CE Mark approval in the European Union for its side-branch stent to treat left main coronary artery disease.
Durham, N.C.-based Tryton already has European clearance for the side branch stent, but only for treating bifurcated large-vessel lesions. The new approval makes the device the only stent cleared in Europe for the left main indication, according to a press release.
“Tryton Medical is dedicated to the treatment of all coronary bifurcations. Obtaining CE Mark approval for the left main indication significantly expands the market opportunity for our stent platform,” CEO Shawn McCarthy said in prepared remarks. “As market leaders, we continue to invest and introduce meaningful product innovation, clinical evidence, and physician education, to advance the standard of care for bifurcated coronary artery disease.”
Tryton won CE Mark approval for the large-vessel indication for its side-branch short coronary stent back in May 2013, when McCarthy told MassDevice.com that the company is hoping for a pre-market approval nod from the FDA for the original Tryton side-branch stent some time this year.
"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," he told us at the time. "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."