Innova Vascular’s Laguna Clot Retriever and Malibu Aspiration Catheter Cleared for Thrombectomy

June 7, 2023—Innova Vascular, Inc. announced that it has received FDA 510(k) clearance for the company’s Laguna clot retriever system and Malibu aspiration catheter system for use in the peripheral vasculature. The two devices compose the Laguna thrombectomy system, which is indicated for nonsurgical removal of emboli or thrombi and/or infusing, injecting, or aspirating fluids into or from blood vessels in the peripheral vasculature.

According to the company, the thrombectomy system offers a comprehensive range of sizes of both the Malibu aspiration catheter and the Laguna clot retriever.

The Malibu device is a single-lumen catheter with a two-way flow control valve at the proximal end. The catheter uses a gradient structural design and a hydrophilic coating for navigability through tortuous vessels. It can be used alone or in conjunction with the Laguna clot retriever.

The Laguna clot retriever system uses a self-expanding laser-cut nitinol design. Radial strength and cell sizes of the retriever are optimized for maximizing clot capture and enabling circumferential clot ingress, noted the company.

John Moriarty, MD, and Kenneth Rosenfield, MD, commented on the devices in the Innova Vascular press release. Dr. Moriarty is Professor of Cardiovascular and Interventional Radiology and Vice Chair of Clinical Research at UCLA School of Medicine in Los Angeles, California. Dr. Rosenfield is Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital in Boston.

“Removing clots quickly, safely, and in large volumes from the body is the holy grail of innovation in vascular interventions right now,” stated Dr. Moriarty. “Everyone is looking for the one device that can answer these common problems.”

Dr. Moriarty continued, “The Malibu aspiration catheter system offers excellent navigability and ease of use, with the ability for operators of all skill levels to remove clots efficiently. When used together with the Laguna clot retriever system, it can efficiently address the need in a range of vessel sizes in various anatomic locations within the peripheral vasculature.”

Dr. Rosenfield added, “Arterial and venous clots pose a significant health risk to our patients. The Laguna thrombectomy system offers an innovative solution to treat a wide range of clots in the peripheral vasculature.”