iVolution

Self-expandable nitinol peripheral stent

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Indication

Treatment of de novo or restenotic atherosclerotic lesions in peripheral arteries located under the aortic arch and for palliation of biliary tract malignant stenosis with a nominal diameter ranging from 4.5 and 9.5 mm.

Specifications

• Recommended guidewire: 0.035”
• Recommended Introducer: 6F
• Recommended guiding catheter: 8F
• Stent material: nitinol
• Wall thickness: 180 – 190 µm
• Expansion shortening <5%
• Circumferential radial force (at 15% strain): 0.120 mN
• Artery coverage: 15% average
• High vessel adaptability
• Usable catheter lengths: 80 cm or 140 cm

Description

iVolution peripheral stent is made out of a nickel/titanium alloy (nitinol). The stent is loaded into the delivery system that will release it at the site of implantation.
The stent is self-expanding, achieving the diameter it has been designed for, once it is released from the delivery system. From that moment on, it remains implanted in the artery, exerting a continuous force on the artery wall to stay open.
The stent design is based on a plurality of undulating rings that extend axially without connection bridges forming an open-cell stent.
The metal at the stent ends is less dense in artery coverage and incorporates a series of radiopaque markers to visualize the stent once expanded.
The stent is made from a nitinol tube that is cut using a laser technique and then expanded to the required final diameter. The surface is then polished to achieve a smooth, shiny finish.
The stent delivery system is a coaxial catheter with triple sheath design, consisting of:
– A guidewire lumen, with the stent accommodated at the distal end. The distal part of this tube ends in an atraumatic tip that carries a radiopaque marker that defines the distal portion of the stent.
– A stent blocking tube which prevents the stent from moving back at the time of its release. The blocking tube has a distal marker which aligns with the proximal part of the stent and indicates the position of the stent within the device.
– A retractable sheath that protects and contains the stent. When the sheath is pulled back, the stent is deployed.
– A fixed sheath partially covers the retractable sheath and protects it, so that if the user touches the catheter, doesn’t block the movement of the retractable sheath.
For the release of the stent, it is necessary to operate the proximal handle of the delivery system. The handle has a locking mechanism that must be disabled to begin the release. The release may be performed slowly, by turning the screw; or it can be performed faster, by pressing the button and pulling back. The handle is ergonomic and can be used with one hand.
The system ends in a soft, atraumatic tip to avoid damaging the artery during its advance.

Clinical Support

iVolution has proven its safety and efficacy in the following clinical trials and registries

EVOLUTION Trial
TINTIN Trial

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