February 27, 2025—Ichor Vascular, Inc. announced the limited market release of its 7-F peripheral reperfusion system.
In July 2024, the company announced FDA 510(k) clearance for the 7-F device, which is indicated for the nonsurgical removal of emboli and thrombi from venous blood vessels. In September 2023, the company announced FDA clearance for its 14-F peripheral reperfusion system.
According to the company, its 7-F arterial and 14-F venous peripheral systems are designed to replicate simple, proven surgical mechanisms—such as compliant balloon sweeping, aspiration, and snaring—without surgery, thrombolytics, or capital equipment.
Ichor Vascular stated that the postmarket evaluation of the system will aim to validate its real-world clinical benefits including faster time to reperfusion, reduced blood loss compared to vacuum pump-based systems, prevention of distal embolization, minimized vessel damage, and the elimination of surgical and drug-related complications.
The company also advised it intends to use the limited release to help refine its approach to improving patient outcomes in peripheral vascular interventions.
Tim Blair, CEO of Ichor Vascular, discussed the device in the company’s press release.
“Ichor endovascularly replicated the parameters of a successful surgical thrombectomy,” commented Blair. “We are poised to demonstrate a single 7-F reperfusion system can be safely utilized across occluded superficial femoral artery stents, occluded bypass grafts, organized thrombus, embolic events, and acute arterial occlusions. Physicians will be able to treat 3- to 10-mm arterial anatomy across a wide range of morphology with a single packaged device. Open the kit and go.”
