Innova Vascular Receives FDA Approval for Two New Thrombectomy Devices

Innova Vascular has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System for use in the peripheral vasculature. The two new devices are collectively known as the Laguna Thrombectomy System.

“Removing clots quickly, safely, and in large volumes from the body is the holy grail of innovation in vascular interventions right now,” says Dr. John Moriarty, professor of cardiovascular and interventional radiology, and vice chair of clinical research at UCLA School of Medicine in Los Angeles, California. “Everyone is looking for the one device that can answer these common problems. 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 anatomical locations within the peripheral vasculature.”

“Arterial and venous clots pose a significant health risk to our patients,” says Dr. Kenneth Rosenfield, section head for vascular medicine and intervention at Massachusetts General Hospital in Boston, Massachusetts. “The Laguna Thrombectomy System offers an innovative solution to treat a wide range of clots in the peripheral vasculature.”

Innova Vascular’s Laguna Thrombectomy System is indicated for non-surgical removal of emboli or thrombi, and/or infusing, injecting, or aspirating fluids into or from blood vessels in the peripheral vasculature. The System offers a comprehensive range of sizes of the Malibu Aspiration Catheter as well as the Laguna Clot Retriever. The Malibu Aspiration Catheter is a single lumen catheter with a two-way flow control valve at the proximal end. The catheter utilizes a gradient structural design and a hydrophilic coating for excellent navigability through tortuous vessels. It can be used alone or in conjunction with the Laguna Clot Retriever, which utilizes 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.

“We strive to bring solutions that are easy to use, safe, and highly effective in treating potentially devastating diseases,” says Sanjay Shrivastava, Ph.D., CEO of Innova Vascular. “The FDA clearance of the thrombectomy devices for use in the peripheral vasculature marks an important milestone in our commitment to develop innovative technologies targeting large, underserved markets. We are grateful to our physician advisors, who play a key role in shaping these solutions.”


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