The Laguna Thrombectomy System is comprised of two separate devices, the Malibu Aspiration Catheter System and the Laguna Clot Retriever System, both were granted the US Food and Drug Administration (FDA) 510(k) approval last year
Innova Vascular announces first use of Laguna Thrombectomy System. (Credit: jesse orrico on Unsplash)
US-based medical device company Innova Vascular announced the successful first commercial use of its Laguna Thrombectomy System in patients with positive physician experience.
Dr John Moriarty and Dr Raj Khalsa, physicians at UCLA Medical Center in Los Angeles and Providence St. Joseph in California, respectively, were the first to use the system in patients.
The Laguna Thrombectomy System comprises two separate devices, the Malibu Aspiration Catheter System and the Laguna Clot Retriever System.
In June last year, Innova Vascular received the US Food and Drug Administration (FDA) 510(k) approval for both the Laguna Clot Retriever System and the Malibu Aspiration Catheter System.
The 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.
Dr Khalsa said: “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. 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 Moriarty 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 Malibu Aspiration Catheter leverages a gradient structural design and a hydrophilic coating to enhance navigability through tortuous vessels.
The catheter is available in 24French (Fr), 20Fr, 16Fr, and 12Fr outer diameters to address different clot morphologies and vessel sizes.
It can be used alone or together with the Laguna Clot Retriever, which uses a self-expanding laser-cut Nitinol design and is available in two diameters.
The radial strength and cell sizes of the retriever are optimised for enhancing clot capture and enabling circumferential clot ingress, said the medical device company.
Innova Vascular CEO Sanjay Shrivastava said: “We are extremely pleased with the early clinical performance of the system and look forward to expanding our product launch in the period ahead.
“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.”