News and analysis on medical technology
FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

E2 Announces FDA Clearances for Hēlo PE Thrombectomy System and Blood Return Device

Endovascular Engineering says Hēlo Return is the first blood-return system cleared for use with continuous vacuum aspiration during clot removal.

By News DeskOctober 13, 20262 min read
A hospital angiography room with a ceiling-mounted C-arm X-ray system, monitors and a draped instrument table
An empty angiography suite with a C-arm fluoroscopy system, the kind of room where catheter-based clot removal is performed. The Hēlo system is not pictured. Andreas Praefcke, public domain, via Wikimedia Commons · Public domain
FDA cleared510(k)FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • Endovascular Engineering (E2) announced 510(k) clearance for its Hēlo Thrombectomy System and the Hēlo Return blood return system on October 12, 2026.
  • The FDA database lists Hēlo Return, submission K253717, as cleared on October 11, 2026, citing the ENGULF trial; it lists earlier clearances for the Helo Thrombectomy System and a Helo Max version.
  • The company's performance claims come from its ENGULF investigational device exemption study and its own cross-study comparisons, which it describes as descriptive only.

Endovascular Engineering, a Menlo Park, California, company known as E2, said on October 12 that the US Food and Drug Administration has granted 510(k) clearance for both its Hēlo Thrombectomy System and Hēlo Return, a system that filters blood removed during a clot-removal procedure and returns it to the patient. The company announced the clearances in a PR Newswire release, read here via its republication on Webull.

The FDA's 510(k) database lists submission K253717 for Helo Return from Endovascular Engineering, received November 24, 2025, with a decision of substantially equivalent on October 11, 2026. The device is classified as a thrombectomy whole blood return system, product code SHJ, and the entry cites clinical trial NCT05597891.

The database also lists an earlier clearance for the Helo Thrombectomy System (K252956), decided December 18, 2025, which cites the same trial, and a Helo Max Thrombectomy System (K261800), decided September 3, 2026. The company's release did not give 510(k) numbers or decision dates for the clearances it announced.

How the system works

According to E2, the Hēlo Thrombectomy System is indicated for the non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature, and for treating pulmonary embolism, a blockage of the lung arteries usually caused by a blood clot. The company said the catheter has a 15F crossing profile with steerable navigation and a 24F funnel at its tip that pulls clot in, which is then broken up through a combination of continuous aspiration and mechanical disruption.

Hēlo Return is indicated for use with the thrombectomy system to collect and filter aspirated whole blood before it is returned to the patient. E2 said it is the first blood-return system cleared for use with continuous vacuum aspiration, supported by testing that evaluated blood quality under those conditions and was presented at the Society of Interventional Radiology meeting in April 2026.

Clinical data cited

The company said the FDA's decision followed review of clinical data from ENGULF, an investigational device exemption study of the Hēlo system. E2 said the platform "showcased the highest reported clot reduction and the lowest estimated blood loss across all PE Thrombectomy IDE studies." A footnote in the release says those figures are for 40 patients treated with blood return, that the comparisons are descriptive only and not derived from head-to-head trials, and that the ENGULF data are on file with the company.

Endovascular Today reported the clearances on October 13 and noted that ENGULF data had been presented at the SIR meeting. In a March release, E2 said a full ENGULF dataset comparing patients treated with and without blood return would be presented at the Society for Cardiovascular Angiography & Interventions meeting in April.

"The treatment of PE with mechanical thrombectomy is rapidly evolving as emerging data and new technologies continue to shape the field. These clearances mark an important milestone in that evolution," said Eric Secemsky, MD, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston, in the company's release.

Dan Rose, E2's chief executive, said: "With dual FDA clearances in hand, we are accelerating our plans to deliver this complete solution to a broad range of physicians and patients." The company did not give launch dates or pricing.

Sources

  1. E2 Secures Dual FDA Clearances for the Hēlo Platform, Introducing a PE Thrombectomy System with Integrated Blood Return, Endovascular Engineering press release (PR Newswire), via Webull, October 12, 2026
  2. 510(k) Premarket Notification K253717: Helo Return, US Food and Drug Administration, October 11, 2026
  3. 510(k) Premarket Notification K252956: Helo Thrombectomy System, US Food and Drug Administration, December 18, 2025
  4. 510(k) Premarket Notification K261800: Helo Max Thrombectomy System (HEL2090), US Food and Drug Administration, September 3, 2026
  5. FDA Clears E2 Hēlo Thrombectomy System and Integrated Blood Return System, Endovascular Today, October 13, 2026
  6. Endovascular Engineering Announces Dual Late-Breaking Presentations at SIR and SCAI 2026, Endovascular Engineering press release (PR Newswire), March 19, 2026