SoCal Company Receives FDA Clearance For Its Clot Removal System
India-West Staff Reporter
IRVINE, CA – Innova Vascular, Inc. based here, has announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for its Laguna Clot Retriever System and its Malibu Aspiration Catheter System for use in the peripheral vasculature. These two cutting-edge devices will be collectively known as the Laguna Thrombectomy System.
“We are committed to delivering solutions that are user-friendly, safe, and highly effective in treating potentially devastating diseases,” said Sanjay Shrivastava, CEO of Innova Vascular, a medical device company. “The FDA clearance of these thrombectomy devices for use in the peripheral vasculature marks a significant milestone in our dedication to developing innovative technologies for underserved markets. We are grateful to our physician advisors, who play a pivotal role in shaping these solutions.”
The need to swiftly and safely remove clots in large volumes from the body is currently the focal point of innovation in vascular interventions,” said Dr. John Moriarty, a professor of cardiovascular and interventional radiology, and vice chair of clinical research at UCLA School of Medicine in Los Angeles.
“Everyone is searching for the one device that can address these common challenges. The Malibu Aspiration Catheter System offers exceptional navigability and user-friendliness, allowing operators of varying skill levels to efficiently remove clots. When used in combination with the Laguna Clot Retriever System, it can effectively handle a range of vessel sizes in different anatomical locations within the peripheral vasculature.”
Innova Vascular’s Laguna Thrombectomy System is designed for the non-surgical removal of emboli or thrombi, as well as for infusing, injecting, or aspirating fluids from blood vessels in the peripheral vasculature. The system offers a comprehensive range of sizes for the Malibu Aspiration Catheter and the Laguna Clot Retriever.
The Malibu Aspiration Catheter is a single lumen catheter equipped with a two-way flow control valve at the proximal end. Featuring a gradient structural design and a hydrophilic coating, the catheter ensures 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. The retriever’s radial strength and optimized cell sizes maximize clot capture and enable circumferential clot ingress.