Innova Vascular Receives FDA Clearance for Two Innovative Thrombectomy Devices: Introducing the Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System

Thursday, June 08, 2023

Innova Vascular, Inc. has recently announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for two of its thrombectomy devices: the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are intended for use in the peripheral vasculature and are collectively referred to as the Laguna Thrombectomy System.

The Laguna Thrombectomy System offers a promising solution for the rapid and safe removal of clots from the body, addressing a crucial need in vascular interventions. Dr. John Moriarty, a renowned cardiovascular and interventional radiology expert from UCLA School of Medicine, praises the Malibu Aspiration Catheter System for its ease of use and exceptional navigability. He highlights its effectiveness in clot removal for operators of varying skill levels. When used in conjunction with the Laguna Clot Retriever System, it can efficiently tackle clots of different sizes and in various anatomical locations within the peripheral vasculature.

Dr. Kenneth Rosenfield, a section head for vascular medicine and intervention at Massachusetts General Hospital, recognizes the significance of the Laguna Thrombectomy System in managing arterial and venous clots. He commends the system for offering an innovative solution that can treat a wide range of clots found in the peripheral vasculature.
Innova Vascular's Laguna Thrombectomy System is specifically indicated for non-surgical removal of thrombi or emboli and for infusing, injecting, or aspirating fluids within the peripheral vasculature. The system includes the Malibu Aspiration Catheter, a single-lumen catheter with a proximal-end two-way flow control valve. It features a gradient structural design and a hydrophilic coating to facilitate easy navigation through complex vessels. The Laguna Clot Retriever complements the catheter with its self-expanding laser-cut Nitinol design, optimized to maximize clot capture and enable efficient clot ingress.

Sanjay Shrivastava, Ph.D., the CEO of Innova Vascular, expresses the company's commitment to developing safe, user-friendly, and highly effective solutions for treating critical diseases. Obtaining FDA clearance for the thrombectomy devices in the peripheral vasculature is a significant milestone for Innova Vascular, as it demonstrates their dedication to providing innovative technologies that cater to unmet needs in large markets. Shrivastava extends gratitude to the physician advisors who have played a vital role in shaping these solutions.


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