Truvic Medical, a subsidiary of Imperative Care, announced today that it won FDA 510(k) clearance for its Prodigy thrombectomy system.
Campbell, California-based Truvic — which was acquired by Imperative Care in July 2021 — designed the Prodigy thrombectomy system to treat peripheral vascular thrombus.
Prodigy is used to redefine peripheral vascular thrombus management by enabling single-session thrombus removal without the use of thrombolytics, according to a news release.
“We are excited to receive FDA clearance for our first thrombectomy system. We look forward to working with experts in the field to translate Prodigy’s novel design elements and features into superb clinical outcomes,” Truvic CEO Mike Buck said in the release. “This represents our first regulatory milestone as part of our strategy to advance multiple programs designed to meet patients’ needs and bring more innovative technologies to the market, faster.”