FDA-Cleared Thrombectomy System Removes Pulmonary Embolism Clots

Catheter-based clot removal can be challenging, as clinicians must navigate fragile vessels and heart valves before reaching large clot burdens. To support clot removal in this difficult anatomy, researchers have developed a thrombectomy system that combines suction with controlled agitation.

Researchers at the University of Michigan (Ann Arbor, MI, USA) developed the Hēlo Thrombectomy System through collaboration between engineering and clinical teams. The device was recently cleared by the U.S. Food and Drug Administration (FDA) for patients with chronic venous thromboembolism involving lung clots. Commercialization is being led by Endovascular Engineering, a University of Michigan startup founded in 2020.

The system is designed to enter the vasculature as a small catheter and expand into a larger funnel once it reaches the clot. The funnel applies suction while a rotating shaft orbits and twists the clot. This action stretches and thins the clot so it can be drawn through the catheter and removed from the body. The approach is intended to reduce reliance on direct grabbing and pulling, which the development team found could damage blood vessels.

The technology originated in work on stroke intervention and was adapted for pulmonary embolism. It was developed at the Biomedical Manufacturing and Design Lab at the University of Michigan and involved collaboration between University of Michigan Engineering, Michigan Medicine, neurosurgery, cardiology, and the University of Minnesota. Endovascular Engineering also reported positive results from the ENGULF trial, a key clinical trial evaluating the Hēlo system for pulmonary embolism treatment, which helped support FDA clearance.

The same collaboration has generated additional minimally invasive medical device efforts, including technologies for cartilage removal, heart pumping assistance, and chronic clot crossing in leg veins. The Hēlo system is presented as an early commercial application before further development of more complex stroke treatment devices.

“The FDA clearance of the Hēlo Thrombectomy System marks a transformative advancement for pulmonary embolism patients. This significant milestone demonstrates the tremendous power of interdisciplinary innovation at U-M, where engineers and clinicians come together to tackle urgent clinical challenges. We’re proud to support startups like Endovascular Engineering, driving breakthrough technologies like Hēlo from university research to patient care” said Kelly Sexton, U-M associate vice president for research—innovation partnerships and economic impact.

“It is an ideal start before the technology advancement and commercialization of more complex stroke treatment devices,” said Albert Shih, professor of mechanical engineering and biomedical engineering.

Related Links
University of Michigan
Endovascular Engineering