August 7, 2014 — Tryton Medical Inc. announced that the first patient has been enrolled in the EXTENDED Access Registry (Tryton IDE XA registry), a single arm clinical study of its Tryton Side Branch Stent. The Tryton IDE XA registry is designed to support FDA submission for U.S. approval and is expected to enroll 133 patients from Europe and the United States. Indulis Kumsars, M.D., P. Stradins University Hospital, Latvian Centre of Cardiology enrolled the first patient.
The Tryton 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 Pivotal IDE Trial will be submitted to the U.S. Food and Drug Administration to seek approval of the device in the United States.
Martin Leon, M.D., FACC, 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 the 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 important work."
“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.”
The Tryton Side Branch Stent is commercially available in Europe and parts of the Middle East, is investigational in the U.S. 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.
For more information: www.bifurcationinstitute.com, www.trytonmedical.com