RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.
- MISAGO® RX Self-expanding Peripheral Stent [Instructions for Use.] Tokyo, Japan: Terumo Corporation; 2017-05.
- Schulte KL, Müller-Hülsbeck S, Cao P, et al. MISAGO 1: first-in-man clinical trial with MISAGO nitinol stent. EuroIntervention. 2010;5:687-691.
- Schulte KL, Kralj I, Gissler HM, 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;19:774-788.
- Müller-Hülsbeck S, Schäfer PJ, Charalambous N, Yagi H, Heller M, Jahnke T. Comparison of second-generation stents for application in the superficial femoral artery: an in-vitro evaluation focusing on stent design. J Endovasc Ther. 2010;17(6):767-776.
- Deloose K, Bosiers M, Callaert J. TVR reduction in the SFA. Endovascular Today. October 2014;44-47. https://evtoday. com/2014/10/tvr-reduction-in-the-sfa/. Accessed March 6, 2019.
- Smouse R. Achieving long-term SFA treatment success: stent design or patient selection. International Symposium on Endovascular Therapy (ISET) 2014, January 18-22, 2014; Miami Beach, FL.
The R2P™ MISAGO® RX Self-expanding Peripheral Stent is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery with reference vessel diameters ranging from 4 mm to 7 mm and lesion length up to 150 mm.
Important Safety Information
Do not use this device in patients who exhibit angiographic evidence of severe thrombus in the target vessel or lesion site before/after undergoing Percutaneous Transluminal Angioplasty (PTA) procedure, patients with contraindication to antiplatelet and/or anticoagulation therapy, patients who are judged to have a lesion that prevents proper placement or deployment of the stent, a lesion that is within an aneurysm or an aneurysm with a proximal or distal segment to the lesion, or a lesion through which a guidewire cannot pass. This device should only be used by a physician who is familiar with, and well trained in, Percutaneous Transluminal Angioplasty (PTA) techniques, stent implantation, and transradial access.