Terumo's Misago Stent to Be Studied in US and Japan

May 12, 2010—Terumo Medical Corporation (Somerset, NJ) announced it has received an investigational device exemption conditional approval from the US Food and Drug Administration for OSPREY (Occlusive/Stenotic Peripheral Artery Revascularization Study), which will evaluate the safety and effectiveness of the Misago selfexpanding stent system for use in the superficial femoral artery. The Misago system, which is commercially available in Europe, consists of a nitinol stent that is premounted on the distal portion of a rapid-exchange delivery catheter.

The OSPREY clinical trial will simultaneously enroll patients in the United States and Japan as part of the Medical Device Collaborative Consultation and Review of Premarketing Applications program under the Harmonization By Doing (HBD) initiative. Terumo's trial was selected as one of two projects to pilot this approach, which is intended to shorten the gap between product approvals in these two health care markets.

HBD is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals. This process is a cooperative effort to move both Japan and the United States toward international regulatory harmonization. The HBD initiative is a pilot project that was launched in December 2003 and seeks regulatory convergence between the US Food and Drug Administration and the Pharmaceuticals and Medical Devices Agency of Japan's Ministry of Health, Labor and Welfare. The information obtained in the “proof-of-concept” trials will assist both regulatory bodies in streamlining the clinical trial process for faster approvals in both countries, as well as promote the idea of global trials for the purpose of collecting better data. In this pilot HBD approach, the products will be submitted for review and approval at the same time.

According to the company, OSPREY is Terumo's first clinical trial for a premarket approval device in the United States. It will include up to 350 patients: a maximum of 250 patients in up to 30 centers in the United States and 100 patients in Japan. Six patients have been enrolled in Japan, where Terumo received regulatory approval to begin the trial last year. The first enrollments in the United States are expected in June 2010.

In the United States, OSPREY is a single-arm, multicenter, nonrandomized, prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the superficial femoral artery. In Japan, there are two arms of the study—50 patients receiving the Misago stent and 50 patients undergoing percutaneous transluminal angioplasty. The primary endpoints of the United States portion of the study are primary stent patency at 1 year as confirmed by duplex ultrasound or angiography and freedom from major adverse events within 30 days of the procedure resulting in target lesion revascularization, amputation of the treated limb, or death. Takao Ohki, MD, is the global principal investigator of OSPREY, and J. Fritz Angle, MD, is principal investigator in the United States.

“I believe this approach to shortening the time for new product approvals between the United States and Japan is critical and exciting,” commented Dr. Ohki, who is Chairman and Professor of Surgery at Jikei University in Japan. “This innovative movement could dramatically solve the current device lag issue between our countries.”