Healthcare Industry News:  Tryton Medical 

Devices Interventional Cardiology

 News Release - January 30, 2007

Tryton Medical Completes Enrollment Phase of First-in-Man Study-- 30 Patients With Coronary Bifurcation Lesions Treated Using Company's Side-Branch Stent(TM)

NEWTON, Mass.--(HSMN NewsFeed)--Tryton Medical, Inc., the leading developer of stents designed to treat bifurcation lesions, announced it completed the enrollment phase of the Tryton First-in-Man (FIM) Study. The multi-center clinical trial evaluated the safety of Tryton's Side-Branch Stent in the treatment of coronary bifurcation lesions. The Study was performed at the: HELIOS Heart Center/Siegburg, Germany (Prof. Eberhard Grube); Thoraxcenter Rotterdam (Prof. Patrick Serruys) and at the Institut Cardiovasculaire Paris Sud, France (Marie-Claude Morice, M.D.).

"The Tryton Side-Branch Stent allowed us to successfully treat a group of patients with challenging bifurcation lesions with an easy-to-use system. The ability to address the side-branch definitively with a Tryton without interfering with treatment of the main vessel is one of the fundamental strengths of this approach. It is unclear how we could have treated these patients without Tryton," said Professor Eberhard Grube, HELIOS Heart Center/Siegburg, Germany. "This technology has the capacity to redefine the treatment of bifurcation lesions and resolve a frequent dilemma of the interventional cardiologist," said Professor Serruys, Head of the Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands.

"We are very pleased with how the Tryton Side-Branch Stent performed in this Study and how quickly the sites were able to incorporate a 'save-the-side-branch' strategy into their routine," said H. Richard Davis, Chief Technical Officer, Tryton Medical, Inc. "This approach permitted interventional cardiologists to address complex bifurcation lesions using their choice of Guide (6 Fr), guide wire, pre-dilation strategy and main vessel sent. The Study should provide the necessary clinical data to support a CE mark," Davis added.

Every year, over half a million bifurcation coronary lesions are sub-optimally treated as no commercially available optimized solution exists for treating bifurcation lesions. As a result, cardiologists are forced to use a provisional strategy which avoids the deployment of a second stent-- leaving the side branch vulnerable to thrombosis and restenosis.

Unlike other stents and techniques used to treat bifurcation lesions, Tryton's stent is easy-to-deliver as it uses standard equipment and techniques compatible with 5 and 6 French guiding catheters. Tryton greatly facilitates patient treatment, as interventional cardiologists who use the Side-Branch Stent will no longer have to worry about the bifurcation as they will know the side-branch will stay open and, as a result, the interventionalist is liberated to focus on the treatment of the main vessel using their preferred choice of standard equipment.

About Tryton Medical, Inc.

Tryton Medical, Inc. is the leading developer of stents that are designed to definitively treat bifurcation lesions. 540,000 bifurcation coronary lesions are sub-optimally treated every year with a variety of time consuming and technically challenging procedures. No optimized solution is commercially available for treating bifurcation lesions. As a result, cardiologists are forced to use a provisional strategy which avoids the deployment of a second stent-- leaving the un-stented side branch vulnerable to thrombosis and restenosis. The ability to definitively treat bifurcation lesions will enable PCI-stenting to become the new standard of care for the treatment of left main coronary artery disease rather than bypass surgery.

Tryton Medical's Side-Branch Stent(TM) has all the characteristics of a state-of the art workhorse stent, providing proven stent coverage to bifurcation lesions while eliminating the need for provisional stenting. For more information on Tryton Medical, Inc., contact Joe Romano, Partner, HighGround, Inc. at +1 781-279-1320 x 208, jromano@highgroundinc.com or visit www.TrytonMedical.com


Source: Tryton Medical

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