Devices & Diagnostics

Stent system from Tryton Medical gets European clearance

Coronary stent technology company Tryton Medical has received European clearance for a larger diameter size […]

Coronary stent technology company Tryton Medical has received European clearance for a larger diameter size of a stent system it has developed for treating a challenging manifestation of coronary artery disease — the buildup of plaque at the point where an artery branches.

But while the CE Mark in Europe should allow Durham, North Carolina-based Tryton to expand overseas sales of its stent system, the product still awaits clearance from U.S. regulators. Clinical trials are ongoing.

Tryton has developed a system to treat bifurcation lesions, a condition where plaque has built up the juncture of a main artery and a side branch. Inserted into the artery, Tryton’s stent system provides support to both the main artery and the side branch. Current approaches to treating bifurcation lesions can leave the side branch unstented and make it vulnerable to restenosis, the re-narrowing of the stented vessel following implantation. Tryton says that research shows bifurcation lesions account for as many as one-third of all coronary lesions.

The new CE Mark covers larger diameters of the stents for larger coronary vessels. Rick Anderson, a Tryton board member and managing director of PTV Sciences, said in a statement that the new larger stent diameter sizes came in response to physician requests.

Tryton’s stent system is currently commercially available in 21 countries in Europe and the Middle East. The company is currently pursuing U.S. clinical trials financed by a $20 million series D round of equity financing completed last year, led by new investor Arnerich Massena & Associates. Other investors included Spray Ventures, PTV Sciences and RiverVest Ventures. 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.

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