Insera Therapeutics, Inc. Receives U.S. FDA 510(k) Clearance for the CLEAR™ Aspiration System Featuring Cyclical Aspiration

FDA clearance marks a major milestone for Insera's digital aspiration system using cyclical aspiration.

DALLAS, Sept. 28, 2026 /PRNewswire/ -- Insera Therapeutics, Inc., a medical device company focused on advancing cyclical aspiration for mechanical thrombectomy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CLEAR™ Aspiration System.

Insera's CLEAR™ Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The FDA-cleared system comprises the CLEAR™ Aspiration Pump and associated single-use disposables, including the INSERA™ Catheter, INSERA™ Aspiration Tubing, and INSERA™ Canister with Non-sterile Tubing, which are compatible with cyclical aspiration using the CLEAR™ Aspiration Pump. The CLEAR™ Aspiration System features cyclical, uniform, and blood saver aspiration modes.

"Receiving U.S. FDA 510(k) clearance for the CLEAR™ Aspiration System represents a defining milestone for Insera's proprietary cyclical aspiration platform, and supplements our CE Mark approval in the European Union," said Vikram Janardhan, Insera's Chief Executive Officer. "As pioneers in cyclical aspiration, we have built our proprietary platform through years of innovation and established a global intellectual property portfolio of 108 patent filings, including 100 issued and allowed patents in the United States and worldwide." Insera's earliest patent family for cyclical aspiration in the vasculature claims priority to 2013 and includes dozens of U.S. and international patents and pending applications covering Insera's pioneering technology, including U.S. Patent No.  12,478,390 and European Patent No. 3,620,203.   

"Having seen the CLEAR Aspiration System in use, I believe it represents a leading-edge technology for peripheral mechanical thrombectomy," said Mahmood Razavi, MD, FSVIR, FSVM, Medical Director of Clinical Trials, St. Joseph Heart & Vascular Center, Orange County, California. "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."

"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," said Italo Linfante, MD, FAHA, Medical Director of Interventional Neuroradiology and Endovascular Neurosurgery, Miami Cardiac and Vascular Institute, Baptist Health South Florida, and Past President of the Society of Vascular and Interventional Neurology (SVIN). "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."

"The U.S. FDA clearance was supported by extensive safety and performance testing, including design verification, usability testing, electrical safety, electromagnetic compatibility, software validation, sterilization validation, packaging validation, biocompatibility testing, and Good Laboratory Practice (GLP) in vivo studies," said Vallabh Janardhan, MD, FAHA, Insera's Chief Medical Officer.

Dr. Janardhan added, "We are grateful to the interventionalists, endovascular surgeons, physicians, scientists, regulatory experts, and all of our collaborators whose tireless dedication to improving the lives of patients with blood clots made this achievement possible."

About Insera Therapeutics

Insera Therapeutics, Inc. is an ISO 13485 certified medical device company focused on advancing cyclical aspiration for mechanical thrombectomy. The company's patented CLEAR™ Aspiration System is a digital aspiration platform designed to remove thrombus from the peripheral vasculature. The CLEAR™ Aspiration System is currently cleared to market in the United States and also holds CE Mark approval in the European Union. Insera Therapeutics, Inc.  is headquartered in Texas. Insera^TM, CLEAR^TM, and CLEAR^TM Aspiration System are trademarks of Insera Therapeutics, Inc. For additional information and company updates, visit https://www.linkedin.com/company/insera-therapeutics-inc/

Reference: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253404

SOURCE Insera Therapeutics Inc.