R2P® MISAGO® RX Self-Expanding Peripheral Stent

Confidently intervene from a radial approach with this peripheral vascular stent

Available on a 200 cm shaft length

USE WITH CONFIDENCE

  • Precise deployment at the lesion site. Minimizes jumping, recoil or foreshortening - with a simplified thumbwheel system that allows for single operation deployment.1

INCREASE EFFICIENCY

  • Responsive in-vitro performance in severe bend situations.2 99.1% freedom from stent fracture per sent post-procedure.1 More flexible stents may be associated with improved patency.3

REDUCE COMPLICATIONS

  • Increased flexibility lowers the potential for stent fracture. The continuous spine-free stent is designed to promote optimal blood flow and eliminate high-strain stress zones that can lead to fracture.1

R2P MISAGO SELF-EXPANDING PERIPHERAL STENT

PROVEN PERFORMANCE IN TREATING PAD PATIENTS WORLDWIDE 1-3

After one year in the OSPREY clinical trial:4

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)1

99.1%*

Freedom from stent fracture

Per stent post procedure1

TERUMO IS IN EVERY DETAIL

The continuous spine-free stent is designed to promote optimal blood flow and eliminate high-strain stress zones that can lead to fracture.2

Combined high-crush resistance and moderate radial force helps to maintain vessel patency along the full length of the lesion.1

RESPONSIVE IN-VITRO PERFORMANCE IN SEVERE BEND SITUATIONS4

No stent fractures recorded during:

90% Torsion Test
Simulated rotation between supine and fetal position.2

40% Compression Test
Simulated response during thigh
compression2

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.

Learn more about our R2P portfolio; access, target, intervene, close

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. 

PRODUCT CODES

R2P MISAGO® RX Self-expanding Peripheral Stent (1 per box)

Product Code Description
SXR06040R 200 cm, 6 Fr, 6 mm x 40 mm
SXR06060R 200 cm, 6 Fr, 6 mm x 60 mm
SXR06080R 200 cm, 6 Fr, 6 mm x 80 mm
SXR06100R 200 cm, 6 Fr, 6 mm x 100 mm
SXR06120R 200 cm, 6 Fr, 6 mm x 120 mm
SXR06150R 200 cm, 6 Fr, 6 mm x 150 mm
SXR07040R 200 cm, 6 Fr, 7 mm x 40 mm
SXR07060R 200 cm, 6 Fr, 7 mm x 60 mm
SXR07080R 200 cm, 6 Fr, 7 mm x 80 mm
SXR07100R 200 cm, 6 Fr, 7 mm x 100 mm
SXR07120R 200 cm, 6 Fr, 7 mm x 120 mm
SXR07150R 200 cm, 6 Fr, 7 mm x 150 mm
SXR08040R 200 cm, 6 Fr, 8 mm x 40 mm
SXR08060R 200 cm, 6 Fr, 8 mm x 60 mm
SXR08080R 200 cm, 6 Fr, 8 mm x 80 mm
SXR08100R 200 cm, 6 Fr, 8 mm x 100 mm

ASSOCIATED PRODUCTS

DOCUMENTS

R2P Misago Brochure
R2P Portfolio Brochure
R2P MISAGO In-Service Guide
 
R2P™ MISAGO® IFU
 
MISAGO Patient Implant Card

REFERENCES

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

*KM Analysis at 12 Months (PSVR ≤ 2.4)

  1. MISAGO® RX Self-expanding Peripheral Stent [Instructions for Use.] Tokyo, Japan: Terumo Corporation; 2020-02.
  2. Müller-Hülsbeck S, Schäfer PJ, Charalambous N, et al. 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.
  3. Smouse, R. Achieving Long Term SFA Treatment Success: Stent Design or Patient Selection. International Symposium on Endovascular Intervention.
  4. Ohki T, Angle JF, Yokoi H, et al. One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study). J Vasc Surg. 2016 Feb;63(2):370-6.e1.
  5. Deloose K, et. al. TVR Reduction in the SFA. EVTODAY. 2014;10:44-47.

Indications
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.

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