United States Enrollment Completed for OSPREY Trial of Terumo's Misago Stent to Treat SFA Disease

July 17, 2012—Terumo Interventional Systems (Somerset, NJ) announced the completion of patient enrollment in the United States in the OSPREY (Occlusive/Stenosis Peripheral Artery Revascularization Study) trial.

According to the company's press release, OSPREY is a single-arm, multicenter, nonrandomized, prospective clinical trial designed to evaluate the safety and effectiveness of Terumo's Misago self-expanding stent system for the treatment of atherosclerotic stenoses and occlusions of the superficial femoral artery.

The trial is composed of 200 patients in 31 centers in the United States and 100 patients in seven centers in Japan. The primary endpoints of the United States arm of the study are: the primary stent patency rate at 1 year, as confirmed by duplex ultrasound of angiography; and, freedom from major adverse events within 30 days of the procedure that would result in target lesion revascularization, amputation of the treated limb, or death. The first implant in the United States in the OSPREY trial occurred in September 2010.

Terumo stated that the Misago device consists of a nitinol self-expanding stent that is premounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers on each end to ensure accurate placement in the lesion. The device is commercially available in Europe.

In the press release, the company noted that the trial's simultaneous patient enrollment in the United States and Japan is part of the Harmonization by Doing (HBD) pilot program. The HBD program is a cooperative effort led by the US Food and Drug Administration, Japan's Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labor, and Welfare along with Terumo Corporation (Tokyo, Japan) and Terumo Medical Corporation (Somerset, NJ). The HBD initiative is intended to shorten the time gap between product approvals in these two healthcare markets.

J. Fritz Angle, MD, who is Professor of Radiology at the University of Virginia, serves as the Principal Investigator of OSPREY in the United States.

“Peripheral vascular disease is a leading cause of disability in the United States, affective between 8 and 12 million Americans. It is critical that physicians and their patients have faster access to the latest technologies in order to maximize treatment options,” said Dr. Angle in the press release. “I look forward to analyzing and discussing the OSPREY data with all of the trial investigators. The international experience and testing efficiencies obtained from our collective participation in this HBD initiative could have a dramatic effect on the way important medical devices reach the market in the future.”