Boston Scientific Begins OMEGA Enrollment

October 5, 2011—Boston Scientific Corporation (Natick, MA) announced the start of patient enrollment in the OMEGA clinical trial, which is designed to evaluate the safety and effectiveness of the company's Omega platinum chromium bare-metal coronary stent system for treating patients with a single coronary artery lesion. OMEGA is a prospective, single-arm trial that will enroll 328 patients at 40 sites in the United States and Europe. The trial's Coordinating Principal Investigators are John Wang, MD, and Prof. Christian Hamm, MD.

“I am enthusiastic about enrolling patients in the OMEGA trial and the potential this advanced bare-metal stent platform holds as a treatment option for patients with coronary artery disease,” said Dr. Wang. “The new alloy and design of the Omega stent promise to offer improved deliverability and visibility, even in patients with complex and challenging anatomy.”

According to Boston Scientific, the primary endpoint of the OMEGA trial is 9-month target lesion failure, a composite measure that includes target lesion revascularization, myocardial infarction, and cardiac death. Target lesion failure rates will be compared to a prespecified performance goal based on historical clinical studies of cobalt chromium and stainless steel bare-metal stents. Patients will undergo clinical follow-up at 30 days, 9 months, and 12 months postprocedure. Trial data will be used to support US Food and Drug Administration approval.

The company stated that like its other platinum chromium stents, the Omega combines radial strength and flexibility while reducing stent recoil. The higher-density alloy provides enhanced visibility while permitting thinner struts compared to previous-generation Boston Scientific stents.

The Omega stent received CE Mark approval in March 2011, and is available in Europe in 48 sizes, ranging in diameters from 2.25 to 4.5 mm and lengths from 8 to 32 mm. In the United States and at participating European Union clinical sites, the Omega stent system is an investigational device that is limited by applicable law to investigational use and is not available for sale, advised Boston Scientific.