Terumo Europe N.V., a leading medical device company, announces the initiation of a new Post-market study: the Prospective, Multicenter, Post-market, Single aRm study, to confIrm the performance of the RenZanTM Peripheral Stent System in treating subjects with SupErficial Femoral and/or Popliteal aRtery disease (PRIZER).
Peripheral arterial disease (PAD) is a progressive disorder caused by atherosclerotic changes in the blood vessel wall, which result in stenosis or occlusion of the arteries outside the heart and brain1. The pathology affects >200 million people worldwide2,3. During the preceding decade alone the number of PAD-affected individuals increased by 13% in high- and by 29% in low-income countries3. The PAD prevalence increases with age, affecting >20% of octogenarians (>80-year-old individuals)1-3. Lower extremity PAD is its most common subset1. PAD is associated with high morbidity and both cardiovascular and all-cause mortality rates. The pathology causes major personal, medical and socio-economic burden, increasingly becoming a global healthcare concern1-4.
The RenzanTM Peripheral Stent System consists of a self-expanding nitinol stent pre-mounted on the distal portion of a rapid exchange (RX) delivery catheter, constructed from 2 layers of tubular braided nitinol wire mesh.
The study plans to enrol 135 patients, in approximately 10 European centers in 5 countries. Patients will be stratified in 2 groups: 90 FEM-POP patients and 45 Isolated POP patients.
The PRIZER Study aims to confirm the safety and efficacy of the RenzanTM Peripheral Stent System in treating subjects with superficial femoral (SFA) and/or popliteal (POP) artery disease and to assess of the primary patency of the artery evaluated at 12 months, compared to clinical results coming from other clinical trials using similar metallic scaffolds.
"My enthusiasm about the dual layer RoadsaverTM stent in the carotid field can be investigated in this way in the even more challenging infra-inguinal area", commented Dr. Koen Deloose, Head of Department of Vascular Surgery at AZ Sint Blasius Dendermonde hospital in Belgium, Principal investigator of PRIZER study. "In current times where drug eluting technology is only reserved for high risk patients and where the need for scaffolding post DCB treatment is high, a lot of interventionalists are really looking for a 'daily practice' modern scaffold that is extremely flexible, well balanced in COF and radial resistive force and easy to implant accurately. The new 018"-compatible nitinol braided RenzanTM stent with dual layer technology over the full length showed in some proof of concept cases to respond extremely well to all my expectations. The PRIZER study offers us the possibility to further investigate the safety and efficacy of the RenzanTM Peripheral Stent System for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease in 135 patients", Dr. Deloose continued.
"We are very proud to contribute to our commitment to physicians and their patients and drive innovation in the field of peripheral artery disease", said Jim Rushworth, Chief Commercial Officer, TIS Global. "With this clinical trial, we explore initiatives to increase our footprint in peripheral interventions."
"This new technology ensures a great flexibility, conformability to the vessel and fracture resistance", commented Dr. Christophe Giot, Chief Medical Officer, Terumo Europe. "The PRIZER study aims to provide scientific evidence for RENZAN stent in patients suffering from Peripheral arterial disease. "
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About Terumo Europe
Terumo Europe, founded in 1971, is a core player in the EMEA healthcare market by providing best in class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets and sells a vast range of medical devices in four main business units: Hospital and Laboratory Systems, Global Pharmaceutical Solutions, Interventional Systems and Cardio Vascular Products. Terumo Europe EMEA headquarters and production facilities are located in Haasrode (Belgium), production facility in Knowsley (UK) and sales units across EMEA.
Please visit www.terumo-europe.com for more information.
About Terumo Corporation
Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for nearly 100 years. Based in Tokyo and operating globally, Terumo employs more than 25,000 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. Terumo will further strive to be of value to patients, medical professionals, and society at large.
1 Shu, J. and G. Santulli, Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis, 2018. 275: p. 379-381.
2 Song, P., et al., Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis. Lancet Glob Health, 2019. 7(8): p. e1020-e1030.
3 Fowkes, F.G., et al., Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet, 2013. 382(9901): p. 1329-40.
4 Hirsch, A.T., et al., ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol, 2006. 47(6): p. 1239-312.
5 Schulte, K.L., et al., MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients. J Endovasc Ther, 2012. 19(6): p. 774-84.
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