Insera’s Clear Aspiration System Cleared by FDA

November 12, 2026—Insera Therapeutics, Inc. recently announced FDA 510(k) clearance for its Clear aspiration system, which is intended for the removal of fresh, soft emboli and thrombi in the peripheral arterial and venous systems.

According to the company, the Clear aspiration system comprises the Clear aspiration pump and associated single-use disposables, including the Insera catheter, Insera aspiration tubing, and Insera canister with nonsterile tubing, which are compatible with cyclical aspiration using the Clear aspiration pump. The system features cyclical, uniform, and blood saver aspiration modes, stated the company.

“Having seen the Clear aspiration system in use, I believe it represents a leading-edge technology for peripheral mechanical thrombectomy,” commented Mahmood Razavi, MD, in the company’s press release. “The availability of an FDA-cleared aspiration platform that offers both uniform and cyclical aspiration, together with a blood saver mode of cyclical vacuum aspiration, is an important advancement for emboli and thrombi aspiration from peripheral arteries and veins.” Dr. Razavi is Medical Director of Clinical Trials, St. Joseph Heart & Vascular Center in Orange, California.

Italo Linfante, MD, added, “In my opinion, cyclical aspiration using the Clear aspiration system represents an important technological advancement in mechanical thrombectomy that I have seen during my career. The Clear digital aspiration platform represents a thoughtful advancement in aspiration technology through cyclical aspiration, and I believe this technology has the potential to influence thrombectomy procedures across multiple peripheral vascular territories.” Dr. Linfante, who is Past President of the Society of Vascular and Interventional Neurology, is Medical Director of Interventional Neuroradiology and Endovascular Neurosurgery, Miami Cardiac and Vascular Institute, Baptist Health South Florida in Miami, Florida.