MAXIMIZERADIAL SOLUTIONS TO PERIPHERAL CHALLENGES

Perform more peripheral procedures for more patients From the leaders in radial access, R2P™ is the first and only portfolio of longer-length radial devices specifically designed for peripheral procedures, including above-the-knee PAD/CLI vascular interventions.

• Optimize entry site management with Slender Technology™

• Leverage the benefits associated with radial access for:– Quicker ambulation, improved patient comfort, and satisfaction1-3

– Increased cath lab efficiencies and decreased overall costs per procedure4,5

UTILIZE A COMPREHENSIVE RADIAL TO PERIPHERAL APPROACH

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INTERVENE Balloon Catheters and StentCLOSE Radial Compression Device

Terumo Interventional Systems is committed to your success with innovative procedural solutions and ongoing support for your most challenging cases.

We are relentlessly seeking new ways to help you apply effective solutions and achieve better outcomes for more patients.

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ACCESS Introducer Sheaths and CathetersTARGET Guidewires and Catheters

• 5, 6, 7 Fr Sizes• 10 cm and 16 cm lengths

Proprietary thin-wall technology and hydrophilic coating facilitate ease of insertion and removal during peripheral procedures

• 6 Fr Size• 119 cm and 149 cm lengths

Fully hydrophilic coating allows for smooth transition within the radial artery and Slender Technology™ provides optimal performance during peripheral procedures

• 7 Fr Size• 120 cm and 150 cm lengths

Guiding catheter with distal hydrophilic coating and Slender Technology™ for optimal performance during peripheral procedures

• 0.035" Straight, Angled, 1.5 mm and 3 mm J Tip• 350 cm, 400 cm and 450 cm lengths

Includes multiple procedural options in shaft stiffness, tip shapes and wire configurations for easier vessel navigation

• 4 Fr Size• 150 cm length

Offers excellent pushability and torque control with multiple tip shapes for selectivity and access to the peripheral vasculature

• 4 Fr Size; Straight, Angled• 135 cm and 150 cm lengths

Double tapered tip provides the smallest crossing profile, giving a near seamless catheter-to-guidewire transition to aid in crossing simple or complex lesions in the peripheral vasculature

ACCESS TARGETIntroducer Sheaths and Catheters6 Slender Technology™ reduces the device outer diameter while maintaining larger inner diameter equivalent

Guidewires and Catheters6 Provides the longest reach via the radial artery for peripheral procedures

• 6 Fr sheath compatibility • 3-8 mm diameter x 20-200 mm length• 200 cm shaft length

The longest 0.035" radial to peripheral capability and Rapid Exchange (RX) technology are designed to mitigate excessive device management and use of contrast media during a peripheral procedure

• 5 Fr sheath compatibility • 2-6 mm diameter x 40-200 mm length• 200 cm shaft length

The longest 0.018" Rapid Exchange (RX) PTA Balloon designed for use in radial to peripheral procedures

• 6 Fr sheath compatibility • 6-8 mm diameter x 40-150 mm length• 200 cm shaft length

The longest stent platform specifically designed for above-the-knee peripheral artery disease interventions via radial access with Rapid Exchange (RX) technology

• Regular 24 cm and Long 29 cm

The #1 preferred radial hemostasis device on the market provides a more precise way of applying pressure to the radial artery

INTERVENE CLOSEBalloon Catheters and Stents6 Rapid Exchange technology enables greater efficiency during peripheral procedures via the radial artery

Radial Compression Device6 Enables precise pressure to the artery following radial procedures

We continue to advance our product portfolio to enable radial access for more peripheral procedures.

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IndicationsThe 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 InformationDo 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 guide wire 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.

References:1. Rao SV, Tremmel JA, Gilchrist IC, et al; Society for Cardiovascular Angiography and Intervention’s Transradial Working Group. Best practices for transradial angiography and intervention: a consensus statement from the Society for Cardiovascular Angiography and Intervention’s Transradial Working Group. Catheter Cardiovasc Interv. 2014;83(2):228-236. 2. Cooper CJ, El-Shiekh RA, Cohen DJ, et al. Effect of transradial access on quality of life and cost of cardiac catheterization: a randomized comparison. Am Heart J. 1999;138(3):430-436. 3. Jolly SS, Yusuf S, Cairns J, et al; RIVAL Trial Group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011;377(9775):1409-1420. 4. Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009;157(1):132-140. 5. Caputo RP, Tremmel JA, Rao S, et al. Transradial arterial access for coronary and peripheral procedures: executive summary by the Transradial Committee of the SCAI. Catheter Cardiovasc Interv. 2011;78(6):823-839. 6. Data on file.

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

©2019 Terumo Medical Corporation. All rights reserved. All brand names are trademarks or registered trademarks of their respective owners. PM-01743

For complete product ordering codes, refer to the Radial to Peripheral Ordering Form.

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Confidently intervene from a radial approachAvailable on a 200 cm shaft length

➊ ➋ ➌ ➍ ➎ ➏ ➐ ➑

PROVEN PERFORMANCE IN TREATING PAD PATIENTS WORLDWIDE1-3

TERUMO IS IN EVERY DETAIL

After one year in the OSPREY clinical triala:

88.6% Freedom from target lesion revascularization Measured using Kaplan-Meier analysis1

82.9% Sustained patency Measured using Kaplan-Meier analysis (PSVR of ≤2.4)1

99.1% Freedom from stent fracture per stent post-procedure1

Increased flexibility lowers the potential for stent fracture4

The continuous spine-free stent is designed to promote optimal blood flow and eliminate high-strain stress zones that can lead to fracture.4

Combined high crush resistance4 and moderate radial force5 helps to maintain vessel patency along the full length of the lesion.

Precise deployment at the lesion site1 • Minimizes jumping, recoil or foreshortening –

with a simplified thumbwheel system that allows for single operator deployment

• Enables exact stent placement – with the pushability of a triaxial catheter design

R2P™ is the first and only portfolio of longer-length radial devices specifically designed for peripheral procedures, including above-the-knee PAD/CLI vascular interventions.

a These results are based on clinical data using femoral artery access and are not based on data specifically related to transradial access.

Responsive in-vitro performance in severe bend situations4

No stent fractures recorded during:

90% Torsion Test Simulated rotation between supine and fetal position

40% Compression Test Simulated response during thigh compression

More flexible stents may be associated with improved patency.6INTERVENE

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IndicationsThe 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 InformationDo 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.

References:1. MISAGO® RX Self-expanding Peripheral Stent [Instructions for Use.] Tokyo, Japan: Terumo Corporation; 2017-05. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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.

©2019 Terumo Medical Corporation. All rights reserved. All brand names are trademarks or registered trademarks of their respective owners. PM-02150

Terumo Interventional Systems is committed to your success with innovative procedural solutions and ongoing support for your most challenging cases.

We are relentlessly seeking new ways to help you apply effective solutions and achieve better outcomes for more patients.

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