Tryton Medical Announces European Launch Of Stent System For Bifurcation Lesions

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 29 Sep 2008 - 2:00 PDT

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Tryton Medical, Inc., a developer of novel stent systems for the treatment of cardiovascular disease, announced today that the company has initiated launch of its novel Side Branch Stent System™ in Europe.

Tryton's Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions at the site of a bifurcation. The system will be available first in the Netherlands, with additional European countries to follow in the coming months. TOP Medical has partnered with Tryton to distribute the device in the Netherlands.

"We are extremely pleased that our Side Branch Stent System is now available to patients and physicians in the Netherlands," said J. Greg Davis, president and CEO of Tryton Medical. "We are excited about the benefits that our technology promises for patients with cardiovascular disease in Europe. We plan to launch in additional countries soon. We also look forward to initiating a multi-center prospective study evaluating the Tryton Side Branch Stent in real-life practice in the coming weeks."

Cardiovascular disease causes nearly half of all deaths in Europe, claiming 4.3 million lives annually. Approximately twenty percent of patients treated for coronary artery disease are treated for bifurcated lesions.

Bifurcation lesions have presented a challenge for cardiologists since the earliest days of angioplasty. Current approaches to treating these lesions have significant limitations. 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.

"The Tryton Side Branch Stent System, which has demonstrated excellent initial clinical results, offers an innovative solution to a persistent problem in the interventional treatment of patients with complex coronary lesions," said Prof. Antonio L. Bartorelli of the Centro Cardiologico Monzino at the University of Milan, who attended today's European Bifurcation Club meeting in Prague where the launch was announced. "I am pleased that this highly deliverable side-branch stent is now available as a treatment option for these difficult-to-treat cases."

The Tryton Side Branch Stent System is used in conjunction with a conventional drug-eluting stent.

About the Tryton Side-Branch Stent System

The Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. These areas of the vascular system are a common location for plaque and are particularly challenging to treat with currently available stent systems. Approximately twenty percent of patients treated for coronary artery disease are treated for bifurcated lesions.

Tryton's highly deliverable 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 System demonstrated excellent six-month clinical results in a first-in-man study of the system in 30 patients, with no restenosis occurring in the side-branch artery. The stent system has received CE Mark approval in Europe and is not approved in the United States.

About Tryton Medical, Inc.

Tryton Medical, Inc., located in Research Triangle Park, N.C., is a leading developer of novel stent systems for the treatment of bifurcation lesions. The company's Side Branch Stent System is designed to offer a dedicated strategy for treating these challenging cases, which occur in approximately twenty percent of patients treated for coronary artery disease. The privately held company is backed by Spray Ventures, PTV Sciences, RiverVest Ventures.

Tryton Medical, Inc.