US-based medical device company Innova Vascular has received the US Food and Drug Administration (FDA) 510(k) approval for two new devices used in the peripheral vasculature.
The two devices include Laguna Clot Retriever System and Malibu Aspiration Catheter System, collectively known as Laguna Thrombectomy System.
The Laguna Thrombectomy System is indicated for non-surgical removal of emboli or thrombi, or aspirating fluids into or from blood vessels in the peripheral vasculature.
The system offers a complete range of sizes of the Malibu Aspiration Catheter along with the Laguna Clot Retriever, said the medical device company.
Innova Vascular CEO 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.”
The Malibu Aspiration Catheter is a single-lumen catheter that leverages a gradient structural design and a hydrophilic coating to provide superior navigability through tortuous vessels.
It comes with a two-way flow control valve at the proximal end and can be used as a stand-alone device or in conjunction with the Laguna Clot Retriever.
Laguna Clot Retriever uses a self-expanding laser-cut Nitinol design, with its radial strength and cell sizes optimised to enhance clot capture and enable circumferential clot ingress.
Massachusetts General Hospital in Boston vascular medicine and intervention section head Kenneth Rosenfield said: “Arterial and venous clots pose a significant health risk to our patients. The Laguna Thrombectomy System offers an innovative solution to treat a wide range of clots in the peripheral vasculature.”
UCLA School of Medicine professor of cardiovascular and interventional radiology and clinical research vice chair John Moriarty said: “Removing clots quickly, safely, and in large volumes from the body is the holy grail of innovation in vascular interventions right now.
“When used together with the Laguna Clot Retriever System, it can efficiently address the need in a range of vessel sizes in various anatomical locations within the peripheral vasculature.”
Innova Vascular is engaged in the development of advanced, minimally invasive solutions to treat arterial and venous thromboembolism.
In February last year, the company teamed up with Cardiovascular Systems (CSI) for the development of a full line of novel thrombectomy devices.
