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Devices Interventional

 News Release - February 7, 2024

Innova Vascular Announces Successful Early Commercial Use of Laguna Thrombectomy System(TM) in Patients

IRVINE, Calif., Feb. 7, 2024 -- (Healthcare Sales & Marketing Network) -- Innova Vascular, Inc. today announced successful early commercial use of the company's Laguna Thrombectomy System™. Physicians at UCLA Medical Center in Los Angeles, California, and Providence St. Joseph in Orange, California, who were the first to use this system in patients, have reported positively on their experience.

Dr. Raj Khalsa, Chief of Interventional Radiology at Providence St. Joseph Hospital, described the System as a "Beautifully engineered device with easy prep, excellent trackability in challenging anatomies, and highly effective clot extraction. The design, with simplicity in mind, is a significant advantage in high-risk procedures." Dr. Khalsa went on to state, "With increasing awareness of venous thromboembolism, the Innova system joins the ranks of a select few large-bore thrombectomy systems, with a remarkably efficient solution that offers substantial value to the healthcare system."

Dr. John Moriarty, Professor of Interventional Radiology and Cardiology and Vice Chair of Clinical Research at UCLA David Geffen School of Medicine, said, "The Laguna Thrombectomy System is a valuable addition to the existing therapeutic options for venous thromboembolism. The system offers excellent navigability and ease of use enabling operators at all skill levels to remove clots efficiently. It addresses the need for large volume clot removal in a range of vessel sizes in various anatomical locations within the peripheral vasculature."

The Laguna Thrombectomy System encompasses two devices developed by Innova Vascular: the Malibu Aspiration Catheter™ System and the Laguna Clot Retriever™ System. Both devices received U.S. Food and Drug Administration (FDA) 510(k) clearance in June 2023.

The Malibu Aspiration Catheter utilizes a gradient structural design and a hydrophilic coating for excellent navigability through tortuous vessels. It is available in 24French (Fr), 20Fr, 16Fr, and 12Fr outer diameters to address a variety of clot morphologies and vessel sizes. The catheter can be used alone or in conjunction with the Laguna Clot Retriever, which utilizes a self-expanding laser-cut Nitinol design and is available in two diameters. Radial strength and cell sizes of the retriever are optimized for maximizing clot capture and enabling circumferential clot ingress.

"We are extremely pleased with the early clinical performance of the system and look forward to expanding our product launch in the period ahead," said Sanjay Shrivastava, Ph.D., CEO of Innova Vascular. "Successful use of the System 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."

About Innova Vascular

Innova Vascular, Inc., is a medical device company based in Irvine, California, engaged in the development of innovative minimally invasive solutions to treat arterial and venous thromboembolism. Its product portfolio includes, but is not limited to, the Laguna Clot Retriever™ System, and the Malibu Aspiration Catheter™ System. Additional information about the company can be found at www.innovavascular.com.

Laguna Thrombectomy System, Laguna Clot Retriever, and Malibu Aspiration Catheter are trademarks of Innova Vascular, Inc.


Source: Innova Vascular

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