The peripheral iVolution Stent is a stent 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 released from the delivery device. 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 stent ends' metal 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 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 a triple sheath design, consisting of a guidewire lumen, with the stent accommodated at the distal end. This tube's distal part ends in an atraumatic tip that carries a radiopaque marker that defines the distal portion of the stent. A stent blocking tube prevents the stent from moving back at the time of its release. The blocking tube has a distal marker that aligns with the proximal part of the stent and indicates the stent's position 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, it doesn’t block the movement of the retractable sheath. For the stent release, 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 being performed quickly by pressing the button and pulling it 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. See IFU for further information. Available to download.
- Triple sheath catheter
- Compatible with 8F guiding catheters
- Compatible with 0.035" guidewire
- Compatible with 6F introducer
- Tip profile: 0.036"
- 4 RO Markers at each end of the stent
- 2 handle sizes: small (L: 40mm-100mm)/Large (L: >100mm)