Terumo Medical Receives IDE for Stent Study

Terumo Medical Corporation received an investigational device exemption (IDE) conditional approval from the U.S. Food & Drug Administration (FDA) for its Occlusive/Stenotic Peripheral Artery Revascularization Study, or OSPREY. The study will evaluate the safety and effectiveness of the company’s Misago self-expanding stent system for use in the superficial femoral artery (SFA).

This marks the company’s first U.S. clinical trial for a premarket approval device. A unique feature of the clinical trial is that it will simultaneously enroll patients in the United States and Japan.

The trial was selected as one of two projects designed to shorten the gap and streamline product approvals in the United States and Japan, through the FDA’s “Harmonization by Doing” project, which is intended to promote further convergence between Japan and U.S. requirements for pre-market submission evaluations and review practices. HBD was launched in 2003. With this study, the stent will be submitted for review and approval at the same time.

“I believe this approach to shorten the time for new product approvals between the U.S. and Japan is critical and exciting,” said Takao Ohki, M.D., chairman and professor, Department of Surgery, Jikei University School of Medicine, Division of Vascular Surgery, and the global principal investigator of the OSPREY trial. “This innovative movement could dramatically solve the current device lag issue between our countries.”

In the United States, OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA. In Japan, there are two arms of the study, 50 patients receiving the Misago stent and 50 control patients receiving percutaneous transluminal angioplasty.

The primary endpoints of the U.S. study are primary stent patency rate at one year as confirmed by duplex ultrasound or angiography, and freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularization, amputation of the treated limb or death.

The study 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. There have already been six patients enrolled in Japan, which received regulatory approval to begin the trial last year.The first U.S. enrollments are expected in June.

The principal U.S. investigator is J. Fritz Angle, M.D., associate professor of Radiology at the University of Virginia. “Peripheral vascular disease management continues to be a major clinical problem,” Angle said. “We need better tools to improve revascularization of femoral-popliteal vessels. I applaud Terumo’s efforts to advance this field.”

The Misago device consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. It currently is available for sale in Europe.

Terumo Interventional Systems, a division of Terumo Medical Corporation based in Somerset, N.J., develops guidewires, catheters, introducer sheaths, guiding sheaths and embolization products.