Pulmonary embolism: U.S. clears new catheter system to remove blood clots

The U.S. Food and Drug Administration has cleared a new system for the nonsurgical removal of blood clots in patients with pulmonary embolism. The Hēlo device was developed by Endovascular Engineering (E2), founded in 2020 as a University of Michigan startup. The clearance was announced on Oct. 13, and the university presented details of the technology on Oct. 26.

The system removes clots through a catheter using suction and a rotating mechanism. The FDA also cleared the Hēlo Return system, which collects and filters aspirated blood and returns it to the patient. The technology was adapted from stroke treatment devices developed jointly by Michigan engineers and the university's medical center. According to the university, the United States records about 900,000 blood clot cases each year, and pulmonary embolism causes 60,000 to 100,000 deaths.

"The FDA clearance of the Hēlo Thrombectomy System marks a transformative advancement for pulmonary embolism patients," said Kelly Sexton, associate vice president for research at the University of Michigan. The company reported positive results from its ENGULF clinical trial, presented in April 2026, though the reports give no specific figures. The university and one of the inventors have a financial interest in E2.