Terumo Introduces New Radial to Peripheral (R2P™) Devices at TCT 2019

Enables the Clinical, Economic, and Patient Benefits Associated with Radial Artery Access

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Sep 26, 2019, 11:00 ET

SAN FRANCISCO, Sept. 26, 2019 /PRNewswire/ -- Terumo Medical Corporation (TMC) today announced that it has introduced the R2P^™ MISAGO^® RX Self-expanding Peripheral Stent at the 31^st Transcatheter Cardiovascular Therapeutics (TCT) Conference, the world's premier educational meeting specializing in interventional cardiovascular medicine. The introduction of R2P^™ MISAGO^® helps physicians bring the benefits associated with a radial access approach to patients with peripheral artery disease (PAD).

According to the US Centers for Disease Control and Prevention (CDC), PAD affects approximately 8.5 million people in the United States (US) and is characterized by a narrowing or blockage of arteries limiting blood flow to the lower extremities; an endovascular approach is often used for treatment.^1,2

R2P^™ MISAGO^® is a device within the Radial to Peripheral (R2P^™) Portfolio, the first and only portfolio of longer-length radial devices specifically designed for peripheral procedures.³ R2P^™ MISAGO^® is the longest stent platform specifically designed for above-the-knee PAD interventions via radial access, incorporating Rapid Exchange (RX) technology and innovative bare metal stent design.³

The launch of R2P^™ MISAGO^® is complemented by the introduction of R2P™ CROSSTELLA^®RX PTA Balloon Dilatation Catheter, the longest 0.018" balloon designed for use in radial to peripheral procedures.³ Both R2P^™ MISAGO^® and R2P™ CROSSTELLA^® have a 200 cm working length, enabling physicians to perform more peripheral procedures for more patients.

"As the industry leader in radial access, Terumo is very proud of the work we have done in partnership with the medical community to drive utilization of radial procedures," said Chris Pearson, Executive Vice President, Commercial Operations, Terumo Interventional Systems. "The launch of these additional devices enhances our existing R2P™ Portfolio, and underscores Terumo's commitment to developing new, innovative technology to advance peripheral vascular care."

"Using radial artery access is associated with quicker ambulation, improved patient comfort, and satisfaction. Terumo's introduction of R2P™ MISAGO^® and R2P™ CROSSTELLA^® as part of the R2P™ Portfolio provides physicians with additional options to treat PAD patients from the wrist," said Dr. John Coppola, MD, FACC and FSCI.

R2P™ MISAGO^® is currently in a limited market release within the US and will have full commercial availability in October 2019. R2P™ CROSSTELLA® is currently commercially available as part of the R2P™ Portfolio of radial length devices.

PM-02351

IMPORTANT SAFETY INFORMATION for R2P™ MISAGO® Self-expanding Peripheral Stent⁴

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.

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.

RX ONLY. Refer to the product labels and package insert for complete warnings, precautions, potential complications, and instructions for use.

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 nearly 50 years, we've continued the Terumo mission of offering the best possible solutions to healthcare providers and the people they serve.

Backed by Terumo Corporation's almost 100 years of experience, TMC has grown from offering a small range of products to manufacturing huge product lines across four divisions: 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; Terumo Pharmaceutical Solutions (TPS), which develops drug delivery devices; and Terumo Business Edge, which offers cardiac cath lab consulting. It's all part of our continued commitment to the values of our founders and "Contributing to Society Through Healthcare." To learn more visit, www.terumomedical.com.

¹ Peripheral Arterial Disease (PAD) Fact Sheet. Centers for Disease Control and Prevention website https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_pad.htm. Updated June 16, 2016. Accessed September 20, 2019.

² Thukkani AK, Kinlay S. Endovascular intervention for peripheral artery disease. Circ Res. 2015;116(9):1599–1613. doi:10.1161/CIRCRESAHA.116.303503

³ Data on File.

⁴ MISAGO^® RX Self-expanding Peripheral Stent [Instructions for Use.] Tokyo, Japan. Terumo Corporation; 2017-05.

SOURCE Terumo Medical Corporation