Clot Ingestion System Receives Breakthrough Device Designation Status

Novel Catheter-based Technology for Treating Acute Ischemic Stroke

Perfuze has been granted breakthrough device designation by the FDA for its Millipede CIS technology, designed to remove clots from the brain following an acute ischemic stroke.

According to the World Health Organization, stroke is the second leading global cause of death and a leading cause of disability. An ischemic stroke occurs when a blood vessel in the brain is blocked by a clot, preventing blood flow. Perfuze’s technology aims to provide superior clinical outcomes in shorter procedural times, resulting in safe, cost-effective therapy.

Perfuze, which was founded in 2018, announced in January 2019 that it had raised more than $3 million in a seed round led by Earlybird, a venture capitalist company, with participation by an Irish syndicate of med-tech veterans and stroke physicians.

“Perfuze has a technology with the potential to significantly improve outcomes for stroke patients,” said Earlybird partner John Yianni. “We are delighted to offer our financial and commercial support in helping this exciting company grow and get its life-saving technology to market.”

Source: fda.gov, Aug. 7, 2019; MassDevice.com