Innova Vascular today announced the successful early commercial use of its Laguna Thrombectomy System in California.
The first physicians to use the system — Dr. Raj Khalsa and Dr. John Moriarty — reported positively after their initial cases.
Khalsa touted the system’s easy preparation, strong trackability in challenging anatomies and effective clot extraction.
“The design, with simplicity in mind, is a significant advantage in high-risk procedures,” Khalsa said. “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.”
Moriarty called Laguna a valuable addition to 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,” he said. “It addresses the need for large volume clot removal in a range of vessel sizes in various anatomical locations within the peripheral vasculature.”
Laguna features Innova Vascular’s Malibu Aspiration Catheter and Laguna Clot Retriever. Both devices received FDA 510(k) clearance in June 2023. Malibu utilizes a gradient structural design and hydrophilic coating for navigability through tortuous vessels. It addresses a variety of clot morphologies and vessel sizes.
The Laguna Clot Retriever has a self-expanding, laser-cut nitinol design with two available diameters. It has optimized radial strength and cell sizes 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, 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.”