MISAGO(tm) Study Enrolling Patients in US and Japan

MUSC one of first in nation to implant new stent system in artery
MISAGO™ study enrolling patients in US and Japan

CHARLESTON, SC (March 15, 2011) - The Medical University of South Carolina (MUSC) became one of the first centers nationwide to implant the MISAGO™ Self-expanding Stent System as part of the Occlusive/Stenotic Peripheral artery REvascularization StudY (OSPREY) in the U.S., which will evaluate the safety and efficacy of the MISAGO™ Peripheral Self-expanding Stent System for use in the superficial femoral artery (SFA), the main blood vessel that supplies blood to the legs and feet.

For patients suffering from peripheral artery disease (PAD), the MISAGO stent system offers a way to improve blood flow to clogged vessels that supply blood to the lower extremities. Approximately eight million Americans suffer from PAD, with the most common symptoms including cramping, pain or tiredness of the leg or hip muscles while walking or climbing stairs. 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.

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 trial was selected to pilot this approach of shortening 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 part of this landmark trial to evaluate the safety and efficacy of the MISAGO Stent System for treating patients with peripheral artery disease," said Marcelo Guimaraes, M.D., MUSC assistant professor of Vascular & Interventional Radiology and principal investigator on the study. "This is a unique and exciting opportunity to be a part of the first international initiative to streamline the regulatory process to facilitate future medical device approvals between countries. I believe this is also important, because it will increase the population awareness of peripheral arterial disease, its symptoms, how to prevent it, and how to manage it adequately."

Peripheral Artery Disease is highly prevalent among individuals with a history of smoking, diabetes, high blood pressure, high cholesterol and in the elderly population. According to Guimaraes, patients who visit the Vascular & Interventional Radiology (VIR) clinic at MUSC have their complaints thoroughly evaluated, with limb pulses and blood pressures checked in about 20 minutes.

"We offer an inexpensive and quick way to grade the level of disease and to make a decision if further diagnostic studies or immediate treatment are needed. It is a great opportunity to educate our patients and to prevent this terrible and highly prevalent disease," Guimaraes said. "The Peripheral Vascular Disease screening program is offered at no additional cost to all patients who come to the VIR clinic at MUSC. We have a multidisciplinary approach in the evaluation of patients with PVD; MUSC is a medical institution where the best therapy (either by risk factors management, medications, open surgery or minimally invasive procedures) is offered for the treatment of any vascular disease from head to toe."

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 and will include up to 350 patients involving 30 centers in the U.S and Japan.

The primary endpoints of the U.S. study are:
* Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography. (need this in lay terms- a 13 year old should be able to read and understand)
* 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. (lay terms needed)

**About MUSC
**_Founded in 1824 in Charleston, The Medical University of South Carolina is the oldest medical school in the South. Today, MUSC continues the tradition of excellence in education, research, and patient care. MUSC educates and trains more than 3,000 students and residents, and has nearly 11,000 employees, including 1,500 faculty members. As the largest non-federal employer in Charleston, the university and its affiliates have collective annual budgets in excess of $1.7 billion. MUSC operates a 750-bed medical center, which includes a nationally recognized Children's Hospital, the Ashley River Tower (cardiovascular, digestive disease, and surgical oncology), and a leading Institute of Psychiatry. For more information on academic information or clinical services, visit _www.musc.eduor http://www.musc.edu/intrad/. For more information, the Vascular & Interventional Radiology clinic can be reached at 843.792-2300.

**Terumo Interventional Systems
**Terumo Interventional Systems (TIS), a strategic business unit of Terumo Medical Corporation, directly markets a full line of guide wires, catheters, introducer sheaths, guiding sheaths and embolization products for use in a multitude of different interventional procedures IS products are unique in accessing and crossing difficult-to-reach lesions, thereby allowing therapeutic intervention in previously unreachable vascular beds.

Contact: Tonya Pilkenton
843.792.4418
pilkento@musc.edu