Extended Access Registry for Tryton Side Branch Stent Begins Enrollment

September 10, 2014—Tryton Medical, Inc. announced that Jeffrey W. Moses, MD, enrolled the first patient in the United States in the Extended Access Registry, a single-arm study of the Tryton side branch stent that is expected to enroll 133 patients from Europe and the United States. Dr. Moses is Director of Cardiovascular Interventions at New York Presbyterian Hospital/Columbia University Medical Center and Professor of Medicine at the Columbia University College of Physicians and Surgeons.

According to the company, the Tryton Extended Access Registry builds on the results of the TRYTON pivotal investigational device exemption (IDE) trial, which showed the benefit of the Tryton device in a post hoc analysis of the intended population: complex coronary bifurcation lesions involving significant side branches. The Tryton Extended Access Registry is designed to confirm these findings. Results from this registry together with the results from the pivotal IDE trial will be submitted to the US Food and Drug Administration to support the company’s application for premarket approval.

In October 2013, the first results from the TRYTON pivotal trial were presented during a late-breaking clinical trial session at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

In Tryton’s announcement, Dr. Moses commented, “We are pleased to provide the United States ‘kickoff’ case for the Tryton Extended Access Registry, which is now up and running in the United States and Europe. The case involved a complex LAD-Diagonal bifurcation, which went smoothly with a great angiographic result. This case underscores how Tryton brings predictability to the treatment of complex bifurcations. We look for this study to confirm results of the IDE trial, demonstrating utility of Tryton in the treatment of complex bifurcation lesions involving significant side branches.”

The company advised that the Tryton side branch stent is commercially available in multiple countries within Europe, the Middle East, and Africa. It is an investigational device in the United States and is not available in Japan.