News | February 04, 2008

Tryton Medical Receives CE Mark Approval for its Side-Branch Stent

February 4, 2008 - Tryton Medical Inc. said it has received CE Mark approval for its Side-Branch Stent, a cobalt chromium balloon-expandable coronary stent specifically developed for the complete treatment of the entire spectrum of coronary artery bifurcation disease.

Approximately 540,000 annual procedures are performed to address bifurcation lesions, accounting for 20% of all coronary lesions treated. With the exception of Tryton's stent, no dedicated solution exists today that fully addresses these lesions, according to the company.

The results of the Tryton 1 (First-In-Man) Study were presented by Patrick Serruys, M.D. (Erasmus University/Thoraxcenter, Rotterdam, the Netherlands) and Ralf Müller, M.D. (Helios Heart Centrum, Siegburg). When the Tryton cobalt chromium Bare Metal Stent was used with a standard drug eluting stent (Cypher Select, Taxus or Xience V), 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,” Dr. Serruys said.

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