Boston Scientific Corp. (NYSE:BSX) launched a new global trial of its next-generation Omega bare-metal stent by enrolling its first patient in Latvia.
The trial will include up to 328 patients across 40 sites in the U.S. and Europe in efforts to determine the safety and effectiveness of the med-tech giant’s bare-metal stent in a single-arm prospective study of coronary artery disease patients.
The third-generation platinum chromium Omega stent won CE Mark approval in the European Union in March 2011, and is under investigational device exemption in the U.S.
"Our platinum chromium drug-eluting stents have been well received by physicians in approved markets, and we look forward to offering a bare-metal stent in the U.S. built on the same advanced platform," BSX’s senior VP and cardiology, rhythm & vascular group chief medical officer Dr. Keith Dawkins said in a press release. "The OMEGA Stent will complement our existing portfolio and give interventional cardiologists the option to treat patients with paclitaxel-eluting, everolimus-eluting or bare-metal stents."
The trial will look at 30 days, 9 months and 12 months of post-procedure data to look at target lesion failure as compared to a pre-specified performance goal based on existing bare-metal stent studies.