First Patient Treated and Enrolled in Terumo Medical Corporation’s Osprey Iliac IDE Clinical Trial
– Trial aims to assure Terumo’s Misago® RX Self-expanding Peripheral Stent is safe and effective –
SOMERSET, NJ, January 18, 2023 – Terumo Medical Corporation (TMC) is pleased to report that the first patient was successfully treated and enrolled in the Osprey Iliac investigational device exemption (IDE) clinical trial (NCT02793492) by Khawar Shaikh, MD, cardiologist and sub-investigator for the clinical trial, in partnership with Gabriel Delgado, MD, and Bhalaghuru Mani, MD — all with Novant Health Heart and Vascular Institute in Matthews, NC.
The study, which was approved by the U.S. Food & Drug Administration (FDA) in April 2022, is a multi-center, single-arm, non-randomized, prospective clinical study to investigate the safety and efficacy of Terumo’s Misago® RX Self-expanding Peripheral Stent for the treatment of de novo, restenotic, and / or occlusive lesion(s) in the common and / or external iliac artery. The stent was approved by the FDA in May 2015 for treatment of lesions in the superficial femoral artery and / or proximal popliteal artery. The primary endpoint is “Major Adverse Events,” assessed at nine months post-procedure, and the study is expected to enroll 75 patients at up to 20 centers.
“This is an important milestone for our Misago stent program,” said Michael J. Martinelli, MD, FACC, FSCAI and Chief Medical Officer, Terumo Medical Corporation. “Terumo remains the leader in providing radial access solutions and, with this program, we are not only expanding into the treatment of iliac disease, but we are also continuing to provide further important data around the benefits of addressing peripheral arterial disease via the radial approach.”
“Novant Health’s Heart & Vascular Institute is committed to providing state-of-the-art care for our patients, including access to emerging treatments through clinical research. As one of seven active Osprey Iliac research sites, our patients have access to a new treatment option for blocked arteries in the pelvic region of the abdomen years earlier than other communities across the country,” said Dr. Shaikh. “Peripheral arterial disease is a major cause of disability and death; however, with timely detection and intervention using the latest treatment advancements, we’re able to prevent amputation and improve the quality of life of our patients.”
About Terumo Medical Corporation
Terumo Medical Corporation (TMC) is a subsidiary of Terumo Corporation, founded in 1972 as the United States expansion of our larger Tokyo-based parent. For over 50 years, TMC has continued the Terumo mission of offering the best possible solutions to healthcare providers and the people they serve. TMC provides products and services across four divisions: Terumo Health Outcomes (THO), which provides healthcare systems with solutions designed to reduce care variation, improve quality metrics, minimize cost and maximize revenue; Terumo Interventional Systems (TIS), which offers solutions for entry site management and lesion access; Terumo Medical Products (TMP), which provides devices for injection and infusion therapy; and Terumo Pharmaceutical Solutions (TPS), which develops drug delivery devices.
Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for over 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large. More information can be found at www.terumo.com.