Side-Branch Bifurcation Stent Earns CE Stamp of Approval


February 7, 2008

February 7, 2008 - Tryton Medical Inc.’s Side Branch Stent obtains CE Mark approval based on results in the Tryton 1 (First-in-Man Study) with No Side-Branch Restenosis in 30 patients, according to the manufacturer.

The Tryton Side-Branch Stent is a cobalt chromium balloon-expandable coronary stent specifically developed for the complete treatment of the entire spectrum of coronary artery bifurcation disease.

The results of the Tryton 1 (First-In-Man) Study were presented by Profesor Patrick Serruys, Erasmus University/Thoraxcenter, and Ralf Müller, M.D., Helios Heart Centrum. When the Tryton cobalt chromium Bare Metal Stent was used with a standard drug eluting stent, no side branch restenosis was observed in the 30 patients treated. The initial 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.

“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.

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