More Than 175 Patients Enrolled in Multi-National Pivotal Trial  

Durham, N.C. –  Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced completion of patient enrollment in the intravascular ultrasound (IVUS) cohort of the randomized, controlled Tryton IDE Study evaluating the TRYTON Side Branch Stent for the treatment of bifurcation disease.  Results of the multi-national Tryton IDE Study will be submitted to the U.S. Food and Drug Administration (FDA) for approval to market the device in the United States.

“The Tryton IDE Study is the first randomized clinical trial of this magnitude to evaluate a dedicated bifurcation stent, and will no doubt make an important contribution to our understanding of PCI-stenting of bifurcation lesions,” said Martin B. Leon, M.D., professor of Medicine and director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, who serves as principal investigator of the study. “IVUS cohort completion is an important recruitment milestone for the Tryton IDE Study, demonstrating the dedication of the superb team of investigators.”

“Tryton Medical is proud of our role in this landmark study,” said Shawn McCarthy, president and CEO of Tryton Medical. “The Tryton IDE Study is the capstone of our clinical program, which includes a growing body of clinical data from more than 700 patients in European registries and investigator-initiated trials that show target lesion revascularization rates consistently below 4% at greater than six month follow-up. These studies complement our experience in approximately 3,500 implants, demonstrating Tryton’s routine use in clinical practice.”

More than 175 patients have been enrolled to date in the Tryton IDE study.  The randomized trial compares a Tryton stent in the side branch vs. the use of balloon angioplasty in the side branch, with both arms of the trial utilizing a standard drug eluting stent in the main vessel. 

The primary endpoint of the study is target vessel failure at nine months. A secondary endpoint is percent diameter stenosis at nine months in the side branch vessel as assessed in an angiographic subgroup. The study will enroll 704 patients at up to 75 centers in North America, Europe and Israel.  Approximately 400 patients will undergo angiographic follow up at nine months.

Source: Tryton Medical, Inc.