Tryton Medical Inc. won European clearance for a larger-diameter side-branch coronary stent.
But while the CE Mark should allow Durham, N.C.-based Tryton to expand overseas sales of the device, the product is still in clinical trials as it waits on FDA clearance..
Tryton developed the system to treat bifurcation lesions, a condition where plaque builds in the juncture of a main artery and a side branch. Inserted into the artery, Tryton’s stent provides support to both the main artery and the side branch. Current approaches to treating bifurcation lesions risk leaving the side branch un-stented. According to the company, research shows that bifurcation lesions account for as many as one-third of all coronary lesions.
The new CE Mark covers wider-bore versions for larger coronary vessels, developed to respond to physician requests, according to prepared remarks from Rick Anderson, a Tryton board member and managing director of backer PTV Sciences.
Tryton, which sells the stent in 21 countries in Europe and the Middle East, is pursuing U.S. clinical trials financed by a $20 million series D equity round last year, led by new investor Arnerich Massena & Associates. Other investors included Spray Ventures, PTV Sciences and RiverVest Ventures. The company announced that the first U.S. patient received the side-stent in January; Anderson said that nearly 3,000 U.S. and European patients have been evaluated so far in clinical trials and commercial use.
Tryton was founded in 2003 by Dr. Aaron Kaplan, a professor of medicine at the Dartmouth Medical School/Dartmouth-Hitchcock Medical Center, and Dan Cole to develop stents treating bifurcation lesions. The company relocated from Massachusetts to Durham in 2008.
