Tryton Medical Enrolls First Patient in Extended Access Registry

Tryton Medical, Inc. has enrolled its first patient in the Extended Access Registry (Tryton IDE XA registry), a single arm study of its Tryton Side Branch stent. The Tryton IDE XA registry is designed to support U.S. Food and Drug Administration (FDA) submission for U.S. approval and is expected to enroll 133 patients from Europe and the United States.

Indulis Kumsars, M.D., of P. Stradins University Hospital, Latvian Centre of Cardiology, enrolled the first patient.

The Tryton investigational device exemption (IDE) XA registry builds on the results of the Tryton IDE study, which showed the benefit of the Tryton Side Branch Stent in the intended population, complex bifurcation lesions involving significant (>2.25 mm RVD by QCA) side branches. The Tryton IDE XA Registry is designed to confirm these results in the intended population. Results from this registry together with the results from the IDE trial will be submitted to the FDA for U.S. approval.

Martin B. Leon, M.D., F.A.C.C., professor of Medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, and founder and chairman emeritus of the Cardiovascular Research Foundation, serves as principal investigator of the Pivotal IDE trial and Extended Access Registry.

“We look forward to the Extended Access Registry to confirm improved outcomes observed in patients with complex bifurcation lesions involving significant side branches, the intended cohort of the Tryton IDE Study,” said Leon. “I thank the Extended Access Registry investigators for continuing to contribute to this work.”

The Tryton Side Branch Stent is commercially available in Europe and parts of the Middle East, is investigational in the United States, and is not available in Japan.

Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. In patients undergoing PCI-­stenting, approximately one-­third have a bifurcation lesion. 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 percent of left main lesions are bifurcation lesions.

The Tryton Side Branch Stent System is built for bifurcation using proprietary Tri-­Zone technology to offer a strategy for treating bifurcation lesions. Tryton’s cobalt chromium stent is deployed in the side branch artery using a standard single-­wire balloon- expandable stent delivery system. A conventional drug-­eluting stent is then placed in the main vessel.

“The Tryton Side branch Stent allows me to treat complex bifurcation lesions in a predictable way securing the large side branch from onset of procedure,” said Kumsars. “I am excited to participate in this study that I expect to confirm the low Tryton peri-procedural MI rates in side branches larger than 2.25 mm, confirming the post-­hoc analysis from the pivotal study.”

Based in Durham, N.C., Tryton Medical develops stent systems to treat bifurcation lesions. The company was founded in 2003 by Aaron V. Kaplan, M.D. (professor of medicine at Dartmouth Medical School/Dartmouth-­‐Hitchcock Medical Center) and Dan Cole of Spray Venture Partners. The privately held firm is backed by PTV Sciences, RiverVest Venture Partners, Spray Venture Partners, and the 3×5 Special Opportunity Fund.