Tryton Medical's Side-Branch Stent Demonstrates Unparalleled 6 Month Angiographic Restenosis Reduction

NEWTON, Mass.--(BUSINESS WIRE)--Oct 5, 2007 - Tryton Medical, Inc. achieved a major medical milestone in stent technology with unprecedented six-month clinical and angiographic results from the Tryton 1 (First-In-Man Study). Dr. Ralf Muller (Helios Heart Center, Siegburg, Germany) and Professor Patrick W.J.C. Serruys (Erasmus Medical Center, Rotterdam, the Netherlands) presented the clinical and angiographic results at the European Bifurcation Club Meeting in Valencia, Spain. The Tryton Side-Branch Stent(TM) was used in conjunction with a standard drug eluting stent to treat 30 patients with coronary blockages involving large side-branches. After 6 months, none of the patients suffered from side-branch restenosis (blockage of the artery). Core laboratory quantitative analysis reported a late loss of 0.27 +/- 0.42 mm in the side branch and 0.12 +/- 0.47 mm in the main vessel.

"The Core Angiographic Data demonstrates that the hybrid approach, bare metal Tryton Side-Branch Stent used in conjunction with a standard drug eluting stent, provides the same type of restenosis reduction we have seen when drug eluding stents are used to treat standard lesions," said Professor Serruys, Erasmus Medical Center, the Netherlands. "This is the first time, I have seen such promising results in the treatment of bifurcation disease," added Serruys.

"The ability to treat bifurcation lesions has been a problem confronting us since the first days of angioplasty", said Dr. Ralf Muller, Helios-Heart Center, Germany. "Tryton seamlessly integrates with other aspects of the angioplasty/stent procedure, allowing interventional cardiologists to treat this challenging patient subset with a high level of predictability and ease. The data shows that Tryton's approach is not only safe, but it reduces restenosis to acceptable levels. I can now treat with confidence, this problem which I confront in nearly 20% of my cases," Muller added.

"To establish Tryton as the gold standard of care for the treatment of bifurcation lesions, Tryton's product must be easy-to-use and reduce restenosis to acceptable levels. The results from our First-In-Man Study demonstrate that Tryton meets both criteria," said H. Richard Davis, CTO, Tryton Medical, Inc.

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. "This technology has the capacity to redefine the treatment of bifurcation lesions and resolve a frequent dilemma of the interventional cardiologist," said Professor Patrick W. J. C. Serruys, M.D., Head of the Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

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.

Contact

HighGround, Inc.
Joe Romano, 781-279-1320 x 208
jromano@highgroundinc.com

Posted: October 2007

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