Medical device company Innova Vascular has secured 510(k) clearance from the US Food and Drug Administration (FDA) for two thrombectomy devices collectively named the Laguna Thrombectomy System.
The two approved devices, namely the Laguna Clot Retriever system and the Malibu Aspiration Catheter system, are intended for application in the peripheral vasculature.
Innova Vascular CEO Dr Sanjay Shrivastava said: “We strive to bring solutions that are easy to use, safe and highly effective in treating potentially devastating diseases.
“The FDA clearance of the thrombectomy devices for use in the peripheral vasculature marks an important milestone in our commitment to developing innovative technologies targeting large, underserved markets. We are grateful to our physician advisors, who play a key role in shaping these solutions.”
The Laguna Thrombectomy System is designed to non-surgically remove emboli or thrombi and infuse, inject or aspirate fluids into or from blood vessels in the peripheral vasculature.
It provides an extensive selection of sizes of the Malibu Aspiration Catheter and the Laguna Clot Retriever.
The Malibu Aspiration Catheter is a single-lumen catheter, which features a two-way flow control valve at the proximal end.
With a gradient structural design and hydrophilic coating, the catheter offers better navigability through tortuous vessels.
It provides the flexibility to be used alone or in combination with the Laguna Clot Retriever, which comes with a self-expanding laser-cut Nitinol design.
The retriever’s strength and cell sizes are optimised to improve clot capture and support circumferential clot ingress.