Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath
Inari Medical, Inc.The Artix™ MT and Artix™ Thin-Walled Thrombectomy Sheath are devices designed to remove clots non-surgically from peripheral blood vessels. They facilitate catheter insertion and vascular access, allowing for mechanical thrombectomy and thrombus aspiration, which assists clinicians in restoring blood flow during vascular interventions.
Intended Use
The Artix™ MT thrombectomy device is indicated for the non-surgical removal of emboli and thrombi from blood vessels, injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel, intended for use in the peripheral vasculature. The Artix™ Thin-Walled Sheath is indicated for the non-surgical removal of emboli and thrombi from blood vessels, injection, infusion, and/or aspiration of fluids, use as a conduit for endovascular devices, and use in facilitating intravascular catheter insertion and guidance in the peripheral vasculature.
Technology
The Artix MT is a single-use, over-the-wire catheter with a self-expanding nitinol element deployed via manual retraction to engage thrombus, deployed through a compatible sheath such as the Artix Thin-Walled Sheath. The sheath facilitates vascular access, provides flow occlusion with a funnel catheter accessory, and allows introduction of endovascular devices. Both devices are tracked over a guidewire under fluoroscopic guidance for minimally invasive thrombus removal in peripheral vessels.
Performance
The devices underwent extensive non-clinical verification and validation testing including packaging, visual inspection, burst, simulated use, hemostasis, tensile, particulate, corrosion, radiopacity, radial force, clot removal, air leak, dye staining, lubricity, vacuum testing, and torque testing. Biocompatibility testing per ISO 10993-1 standards and sterilization validation were completed. No clinical or animal testing was required for equivalence determinations.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/28/2024
3 months - 2
FDA Approval
10/15/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.