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MISAGO® RX Self-Expanding Peripheral Stent

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Dr. Ruef Procedural Video
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TERUMO IS IN EVERY DETAIL

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PUSHING BOUNDARIES

The TERUMO difference — exceptional quality instruments that spark procedural innovation so you can do more. Now TERUMO introduces a self-expanding peripheral stent called MISAGO, with a difference that you can see and feel in every detail.

Highlights of the MISAGO peripheral stent include:

  • Precise deployment with simplified single-operator system1
  • Optimal radial force to reduce thrombosis and neointima hyperplasia2
  • Increased flexibility in severe bend situations3
  • Proven performance in treating patients worldwide with PAD1,4,5

SEE THE DIFFERENCE

Increased flexibility lowers the potential for stent fracture3

Take a close look at the open-cell structure. The continuous spine-free stent is designed to promote optimal blood flow and eliminate high-strain stress zones that can lead to fracture.3

  • In the OSPREY clinical trial — 0.9% incidence of stent fracture per stent at 12 months post-procedure1
MISAGO Stent Design
MISAGO_image

Optimized radial force to reduce thrombosis and neointima hyperplasia
The MISAGO peripheral stent combines high crush resistance3 with moderate radial force2 to maintain vessel patency along the full length of a the lesion.

FEEL THE DIFFERENCE

Responds to a patient’s natural anatomy with increased conformability4
Responsive in-vitro performance even in severe bend situations3

In comparison to other self-expanding nitinol stents tested, the MISAGO peripheral stent demonstrated unsurpassed flexibility and durability in rigorous fatigue-testing simulations.

No stent fractures recorded during:

MISAGO Compression


40% Compression Test
 that simulated the femoropopliteal response during thigh contraction

MISAGO Torsion


90° Torsion Test
that simulated the rotation between supine and fetal position

More flexible stents may be associated with improved patency.6

Precision deployment at the lesion site1

  • Minimizes jumping, recoil or foreshortening – with a simplified thumbwheel system that allows for single operator deployment of the stent.
  • Enables exact stent placement
       – with the pushability of a triaxial catheter design
Reduces friction during stent delivery with a static proximal shaft

Reduces friction during stent delivery with a static proximal shaft

MAKE A DIFFERENCE

Realize meaningful long-term outcomes

Improvement in claudication symptoms7*
Indicated by the Walking Impairment Questionnaire

MISAGO WIQ Chart
MISAGO Sustained Patency Number

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

MISAGO Freedom from TLR Number

88.6% Freedom from target lesion revascularization – Measured at one year using Kaplan-Meier analysis (PSVR of ≤2.4)1

Physicians in the OSPREY clinical trial reported 100% success in delivering the MISAGO peripheral stent to the lesion site.1

* At baseline, the majority of patients had moderate to severe claudication as measured by the Rutherford-Becker Scale. At 1 and 12 months post-procedure, a majority of subjects were asymptomatic.1

Peripheral Vascular Disease (PVD) or Peripheral Arterial Disease (PAD), a disease where cholesterol, fatty deposits and/or calcium known as plaque, narrow or block arteries limiting blood flow. A common area affected by PAD is found in the major thigh artery called the Superficial Femoral Artery (SFA) and continues to the knee via the Proximal Popliteal Artery (PPA). Worsening disease states of PAD can lead to Critical Limb Ischemia (CLI) and may be associated with pain (claudication) or increase the potential for amputation. Depending on the Rutherford classification of disease and the TASC lesion type, treatments may include a peripheral intervention procedure.

Terumo offers a portfolio of tools to support peripheral intervention procedures, including PINNACLE PRECISION ACCESS SYSTEM® to help achieve smooth atraumatic vascular access; GLIDEWIRE ADVANTAGE® Guidewire to reach and cross the target lesion; PINNACLE® DESTINATION® Guiding Sheath to introduce interventional and diagnostic devices; and NAVICROSS® Support Catheter to guide and support a guide wire. These products, in concert with The MISAGO® RX Self-expanding Peripheral Stent, a Bare Metal Stent (BMS) on a Rapid Exchange (RX) monorail delivery system indicated to improve luminal diameter in de novo or restenotic native lesions or occlusions of the SFA and/or PPA, provide a comprehensive solution for PAD.

MISAGO SKUs

STENT LENGTH
DIAMETER (mm) 40 60 80 100 120 150
6 SXR06040L SXR06060L SXR06080L SXR06100L SXR06120L SXR06150L
7 SXR07040L SXR07060L SXR07080L SXR07100L SXR07120L SXR07150L
8 SXR08040L SXR08060L SXR08080L SXR08100L  

Indications:

The 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 4mm to 7mm and lesion length up to 150mm.

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, 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 and stent implantation.

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

References

  1. MISAGO® IFU 2015-02.
  2. Deloose K, et al. TVR Reduction in the SFA. EVTODAY. 2014;10:44-47.
  3. 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.
  4. Schulte Karl-Ludwig et al. MISAGO 1: first-in-man clinical trial with Misago™ nitinol stent. EuroIntervention 2010;5:687-691.
  5. Schulte K, 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.
  6. Smouse, R. Achieving Long Term SFA Treatment Success: Stent Design or Patient Selection. International Symposium on Endovascular Therapy, January 2014.
  7. Data on file. Terumo Medical Corporation – WIQ Report - 51315.