Innova Vascular has announced successful early commercial use of the company’s Laguna thrombectomy system. Physicians at University of California (UCLA) Medical Center in Los Angeles, USA and Providence St. Joseph in Orange, USA, were the first to use this system in patients and have reported positively on their experience, a press release states.
Raj Khalsa (St. Joseph Hospital, Orange, USA) 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.” 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.”
John Moriarty (UCLA Medical Center, Los Angeles, USA) 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 US Food and Drug Administration (FDA) 510(k) clearance in June 2023.
The Malibu aspiration catheter utilises a gradient structural design and a hydrophilic coating for excellent navigability through tortuous vessels. It is available in 24Fr, 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 utilises a self-expanding laser-cut Nitinol design and is available in two diameters. Radial strength and cell sizes of the retriever are optimised for maximising 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 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.”