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.