Tryton Side Branch Stent System Designed For Bifurcations: Patient Enrollment Complete In Landmark Pivotal Study

In short

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, has announced the completion of enrollment in the Tryton Pivotal IDE trial evaluating the company’s Side Branch Stent.™

Background

In patients undergoing PCI-stenting, approximately one-third have a bifurcation lesion, presenting the physician with a time-consuming and technically difficult procedure. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis.

The Tryton Side Branch Stent System is designed and built for bifurcations using proprietary Tri-zone™ technology to offer a dedicated strategy for treating these 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 landmark Tryton pivotal study is an international randomised trial that compares a Tryton stent in the side branch vs. conventional provisional stenting (balloon angioplasty) in the side branch, with both arms of the trial utilizing a standard drug eluting stent in the main vessel. The study, which is the first and only randomized IDE pivotal clinical trial to evaluate a dedicated bifurcation stent, has enrolled 704 patients at 67 centers in North America, Europe and Israel. 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.

Physician comments

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 study.

“Completion of patient recruitment is a major milestone for the Tryton IDE Pivotal Trial, which is truly a landmark study. In addition to being the first powered randomised controlled trial evaluating a dedicated side branch stent, it is the largest coronary bifurcation study ever attempted and the first one to have core angiographic (3D and planar) and IVUS sub-studies. The results of the Tryton study will directly guide the treatment of patients with complex bifurcation disease,” said Dr. Leon. “Our current inability to treat these lesions with ‘work horse’ drug eluting stents, represents an important unmet clinical need which confronts interventional cardiologists. From my travels to Europe and Israel, I have been impressed with how easily the Tryton Stent is incorporated into routine practice. We look forward to results from this trial.”

Company comments 

“Tryton Medical’s differentiated technology addresses the challenges of bifurcated lesions, which affect nearly a third of patients undergoing a PCI procedure. Data from more than 1,000 registry patients in Europe treated with the Tryton stent are already challenging provisional stenting, with compelling results of target lesion revascularization of four percent and thrombosis of 0.5 percent at one year,” said Shawn P. McCarthy, president and CEO of Tryton Medical. “We are looking to corroborate this positive registry data in the Tryton Medical randomized controlled study. With more than 6,000 implants to date, we are leveraging our impressive data to further expand globally. We are on track to be the first and only approved stent for coronary bifurcations in the U.S.”

Regulatory status

The stent system has received CE Mark and is commercially available throughout Europe, Russia and the Middle East. It is approved in the United States for investigational use only.

Source: Tryton Medical, Inc., Business Wire