Terumo Medical Corporation Announces First U.S. Patient Implant In Landmark Pilot Study Simultaneously Enrolling In The U.S. & Japan

Main Category: Cardiovascular / Cardiology
Also Included In: Vascular;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 10 Sep 2010 - 4:00 PDT


Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation, announced the first U.S. patient implant in the Occlusive/Stenotic Peripheral artery Revascularization Study (OSPREY), which will evaluate the safety and efficacy of its MISAGO™ Peripheral Self-expanding Stent System for use in the superficial femoral artery (SFA). The procedure was performed at the Bradenton Cardiology Center in Bradenton, Florida.

A unique feature of the OSPREY clinical trial is that it will simultaneously enroll patients in the U.S. and Japan. Referred to as "Medical Device Collaborative Consultation and Review of Premarketing Applications" under the larger Harmonization by Doing (HBD) initiative, the OSPREY 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 significant world healthcare markets. The pilot program is a cooperative effort led by the U.S. Food & Drug Administration, the MHLW-PMDA (Japan's regulatory bodies), Terumo Corporation based in Tokyo, Japan, and Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation.

"We are pleased to be the first U.S. center to kick off this exciting international trial to evaluate the safety and efficacy of the MISAGO Stent System for treating patients with peripheral artery disease," said Srinivas Iyengar, MD, primary operator and site Principal Investigator for the OSPREY trial. "This is a unique and exciting opportunity for myself and the Bradenton Cardiology Center to be a part of the first international initiative to streamline the regulatory process to facilitate future medical device approvals between countries."

In the U.S., 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 System and 50 patients receiving percutaneous transluminal angioplasty (PTA).

The primary endpoints of the U.S. study are:

-- Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography.

-- 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 U.S. and 100 patients in Japan. Japan received regulatory approval to begin the trial last year and has already started to enroll patients.

"Terumo Medical Corporation welcomes the Bradenton Cardiology Center into the OSPREY trial. We are not only grateful that our MISAGO Stent System was selected for the Harmonization By Doing program, but we feel privileged to be chosen as the first medical device company to embark in this important clinical initiative with two of the world's most preeminent regulatory bodies," said Juichi "Jim" Takeuchi, President and CEO, Terumo Medical Corporation. "We are proud of the MISAGO Stent System as our first PMA medical device and look forward to continuing to enroll patients into the OSPREY trial to bring this innovative peripheral artery disease treatment to the U.S. market."

The MISAGO™ Peripheral Self-expanding Stent System 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. The unique design distributes the dynamic superficial femoral artery stress loads throughout the stent's struts providing not only flexibility, but also durability against bending, compression, and torsion. The MISAGO Stent System features the first rapid-exchange (RX) delivery catheter for use in the SFA.

The MISAGO Stent System is manufactured in Japan by Terumo Corporation and has been available in Europe since November 2007. To date, approximately 9000 femoral-popliteal units have been sold (7500 patients treated).

About Peripheral Artery Disease

According to the American Heart Association, approximately eight million Americans suffer from peripheral artery disease (PAD). Unfortunately, PAD is often undiagnosed by healthcare professionals, because the symptoms can be mistaken for some other condition. The most common symptoms are cramping, pain or tiredness in the leg or hip muscles while walking or climbing stairs. Typically, the pain goes away with rest, but flares up again when walking resumes. Most cases of PAD can be managed with lifestyle changes and medical therapy; however, left untreated this condition can lead to gangrene and amputation of the affected limb.

Source: Terumo Medical Corporation

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