E2 a medical device company advancing endovascular therapies, today announced the completion of patient enrollment in the pivotal cohort of its ENGULF Investigational Device Exemption (IDE) study. The trial evaluates the Helo™ PE Thrombectomy System  a novel technology designed for the treatment of pulmonary embolism (PE)—a life-threatening condition caused by blood clots in the lungs.

The ENGULF Study (NCT05597891) was conducted at 19 leading U.S. interventional cardiology, radiology and vascular surgery centers. It follows the successful feasibility cohort of the ENGULF IDE study that was published in JSCAI in May, 2024. Both studies add to the body of clinical evidence highlighting the impact of the Helo PE Thrombectomy System.

"The quick enrollment and collaborative spirit of the ENGULF investigators was remarkable and an indicator of the excitement around the opportunity to evaluate new technologies for PE like the Helo System," said Dr. Julie Bulman, Co Principal Investigator from Beth Israel Deaconess Medical Center in Boston. "We look forward to reporting the outcomes of the trial later this year and adding to the important body of evidence for the treatment of Pulmonary Embolism."

The Helo PE Thrombectomy System represents a breakthrough in clot removal technology, featuring a patented dual-action mechanism that integrates powerful aspiration with advanced clot disruption. The Helo Thrombectomy System incorporates Flow Mitigation Technology™, enabling physicians to remove clot while minimizing blood loss—a critical factor in treating patients with PE.

"Our physician partners, patient volunteers, and the E2 team share the common purpose of improving the treatment of PE," said Dan Rose, CEO of E2. "We believe the Helo System offers distinct advantages over the current standard of care and now we are one very large step closer to making this life-saving technology available to patients across the U.S."

Pulmonary embolism is a major cause of cardiovascular death and disability. Current treatments often face trade-offs between effectiveness and safety. The ENGULF study aims to demonstrate that the Helo Thrombectomy System can address both.

E2 extends sincere thanks to its clinical partners, investigators, and strategic investors for their continued support. The company looks forward to sharing study outcomes and continuing its mission to redefine PE intervention.

 

Source: prnewswire.com

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