FDA clears University of Michigan suction-and-agitation device for lung clot removal

A medical device developed at the University of Michigan that removes blood clots from the lungs by combining suction with mechanical agitation has received clearance from the U.S. Food and Drug Administration. The Hēlo Thrombectomy System, designed for patients with chronic venous thromboembolism, is being commercialized by Endovascular Engineering, a U-M startup founded in 2020. The clearance applies to treatment of pulmonary embolism, one of the forms that chronic venous thromboembolism can take, and follows positive results reported in the company’s ENGULF trial, a key clinical trial evaluating the Hēlo system for pulmonary embolism treatment.

The device addresses a persistent clinical challenge. Patients with persistent blood clots require frequent medical interventions just to survive, yet the University of Michigan notes there have been few advancements in how these patients are treated. Conventional methods of pulling clots out through the blood vessels can damage fragile vessel walls. The Hēlo system instead draws the clot into its catheter with suction and uses an agitator to stretch and thin the clot, allowing targeted and efficient removal before the material is vacuumed out of the body. The approach was originally designed for stroke intervention and has since evolved to remove lung clots.

The technology originated in the Biomedical Manufacturing and Design Lab, led by Albert Shih, the Yoram Koren Collegiate Professor of Engineering in the U-M College of Engineering and a professor of mechanical engineering and biomedical engineering. Three former engineering Ph.D. students played central roles: Yihao Zheng, now an associate professor at Worcester Polytechnic Institute; Yang Liu, now an associate professor at Shanghai Jiao Tong University; and Jeffrey Plott, now an assistant research scientist for U-M Cardiac Surgery. The engineering team worked closely with Luis Savastano, a former U-M neurosurgery resident and now assistant professor at the University of California, San Francisco, who played a pivotal leadership role, and Aditya Pandey, the Julian T. Hoff M.D. Professor of Neurosurgery at U-M.

Shih described the collaboration as spanning cardiology and neurosurgery, producing a series of interventional neurocardiovascular devices that began with a 2012 NSF advanced manufacturing project and continues today. According to Shih, Endovascular Engineering is one of three successful startups in the past six years commercializing ideas from this collaboration, which has also developed minimally invasive devices for cartilage removal, heart pumping assistance and chronic blood clots crossing in the leg veins. He called the Hēlo system an ideal start before the technology advancement and commercialization of more complex stroke treatment devices, and said it has been incredible seeing the system’s impact on the lives of patients with pulmonary embolism by providing a minimally invasive treatment that was not possible before.

Endovascular Engineering received critical early support from U-M Innovation Partnerships, the Coulter Translational Research Partnership Program and the MTRAC Life Sciences Innovation Hub, which helped accelerate the company’s journey from lab innovation to market launch. Since its founding, the company has raised $42 million in Series B financing and $80 million in Series C financing. Kelly Sexton, U-M associate vice president for research—innovation partnerships and economic impact, said the FDA clearance marks a transformative advancement for pulmonary embolism patients and demonstrates the power of interdisciplinary innovation at U-M, where engineers and clinicians come together to tackle urgent clinical challenges. The disclosure notes that Pandey and the University of Michigan hold a financial interest in Endovascular Engineering.

Subject of Research: FDA clearance of the Hēlo Thrombectomy System for pulmonary embolism

Article Title: Embolism treatment developed at U-M receives FDA clearance

Article References: Embolism treatment developed at U-M receives FDA clearance. Original publication (Bibliographic details unavailable.)

Image Credits: AI Generated

DOI: Not provided

Keywords: FDA clearance, pulmonary embolism, thrombectomy, chronic venous thromboembolism, University of Michigan, Endovascular Engineering, medical device, biomedical engineering, interventional neuroradiology, startup commercialization, Embolism, treatment