July 18, 2024—Ichor Vascular Inc. announced it has received FDA 510(k) clearance for the company’s 7-F peripheral reperfusion system, which is indicated for the nonsurgical removal of emboli and thrombi from venous blood vessels.
According to Ichor Vascular, its percutaneous arterial and venous peripheral solutions are designed to replicate simple, proven mechanisms of action (compliant balloon sweeping, aspiration, and snaring) without the need for surgery, lytics, or capital equipment.
Additionally, it noted that the Ichor Vascular reperfusion system provides interventional versatility and simplicity that fit into current workflows and treatment algorithms for peripheral thrombectomy.
Postmarket data will be focused on improving time to reperfusion; reductions in blood loss compared to vacuum pump-based systems; reductions in distal embolization; eliminating vessel and valve damage; and reducing or eliminating surgical and drug complications by embracing a straightforward endovascular approach, advised the company.
“We essentially replicated the parameters of a successful surgical thrombectomy; we simply made it an endovascular procedure,” commented Tim Blair, CEO of Ichor Vascular, in the company’s press release. “Physicians will be able to treat 3- to 10-mm arterial anatomy across a wide range of morphology—from acute clot, acute-on-chronic clot, and embolic material to lengthy organized thrombus—with a single packaged device. Open the kit and go.”
