Tryton Receives CE Mark Approval For Side-Branch Stent
Tryton Medical has received CE Mark approval for its Side Branch Stent. The Tryton Side-Branch Stent is a high performance 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.
The results of the Tryton 1 (First-In-Man) Study were presented by Prof. Patrick Serruys (Erasmus University/Thoraxcenter, Rotterdam NL) and Ralf Muller, M.D. (Helios Heart Centrum, Siegburg DE). 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," said Professor Patrick W. J. C. Serruys, M.D., Head of the Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
"CE Mark will allow us to bring this important technology to market in Europe. A market launch is planned for May in conjunction with EuroPCR 2008," stated 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.