Durham-based medical device developer Tryton Medical has received U.S. Food and Drug Administration approval to market the company’s Tryton Side Branch Stent for the treatment of coronary bifurcation lesions.

Tryton Medical specializes in the development of stents for bifurcated lesions, to open clogged arteries in tricky spots where they form a “Y.” Coronary artery disease,the leading cause of death in the U.S. in both men and women, often results in the buildup of plaque at a site where one artery branches from another, technically known as a bifurcation.

Current approaches to treating these lesions are time-consuming and complicated. As a result, the side branch is often left un-stented, leaving it vulnerable to higher rates of restenosis, or the re-narrowing of the stented vessel following implantation.

The company’s Tryton Side Branch Stent technology addresses the challenges of bifurcated lesions, which affect nearly one-third of patients undergoing a stenting procedure. Tryton’s is the first dedicated bifurcation device to receive regulatory approval in the U.S.

“With this first-of-its-kind approval in the U.S., interventional cardiologists now have access to a stent that is specifically engineered to provide the complete lesion coverage and more predictable patient outcomes needed for the challenging anatomy of coronary bifurcation lesions,” said Shawn McCarthy, Tryton’s president and CEO.

Moved from New Hampshire to Durham in 2008

Tryton was founded in 2003 by Aaron V. Kaplan, M.D., professor of medicine at the Geisel School of Medicine/Dartmouth-Hitchcock Medical Center, in Hanover, N.H., to develop stents for the definitive treatment of bifurcation lesions. The company subsequently relocated to Durham in 2008.

“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Kaplan, who serves as chief medical officer of Tryton. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”

Tryton has signed a strategic distribution agreement with Cardinal Health enabling Cordis, its interventional vascular business, to be the exclusive distributor of the Tryton Side Branch Stent in the U.S.

“This strategic agreement is a significant step for Cordis to quickly get innovative technologies into the hands of our customers in the U.S.,” said David Wilson, president of Cordis. “We are actively preparing to commercially launch this product with Tryton to ensure physicians will soon have a new treatment option in their cath labs to help deliver the best patient care available.”

(C) N.C. Biotechnology Center