Tryton Medical, a developer of stents for the treatment of bifurcation lesions, has received CE Mark approval for its Side Branch Stent.
The Side-Branch Stent is a cobalt chromium balloon-expandable coronary stent, developed for the treatment of the spectrum of coronary artery bifurcation disease, according to the Newton, Mass.-based Tryton.
Patrick Serruys, MD, of Erasmus University, Thoraxcenter in Rotterdam, Netherlands, and Ralf Müller, MD, of the Helios Heart Centrum in Siegburg, Denmark, presented the results of the Tryton I (First-In-Man) Study at the European Bifurcation Club Meeting in Valencia, Spain, in September 2007.
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 and up to a minimum of one year, according to the company.
The company has planned a European market launch for May, in conjunction with EuroPCR 2008, said H. Richard Davis, chief technical officer of Tryton.