E2 to Unveil Landmark PE Data, Setting New Clinical Bar for Thrombectomy

MENLO PARK, CA – March 19, 2026 – Endovascular Engineering, Inc. (E2) is poised to address a critical scientific gap in the treatment of pulmonary embolism (PE), announcing it will present comprehensive new data from its ENGULF study in two late-breaking sessions at leading medical conferences in April. The findings, centered on the company's Hēlo® Thrombectomy System, are expected to provide an unprecedented level of evidence on blood management during clot removal and offer a detailed comparison of procedural strategies, potentially reshaping the standard of care in a rapidly evolving market.

The presentations will take place at the Society of Interventional Radiology (SIR) and the Society for Cardiovascular Angiography & Interventions (SCAI) annual meetings. An acceptance into a late-breaking slot is reserved for highly anticipated research with the potential to meaningfully influence clinical practice, signaling the medical community's significant interest in the results.

Establishing a Scientific Foundation for Blood Safety

One of the most significant contributions from the upcoming presentations will be a comprehensive validation of blood quality when it is returned to the patient during a mechanical thrombectomy procedure. For years, the safety of this practice, known as autotransfusion, has been debated, with clinicians relying on extrapolations from dissimilar fields like trauma surgery or animal studies. Neither of these models accurately reflects the controlled environment or specific patient population of a modern PE intervention.

At the SIR meeting, Dr. Julie C. Bulman, National Co-Principal Investigator for the ENGULF study, will present a detailed analysis combining prospective clinical data with laboratory testing of returned blood. This research aims to replace assumption with hard science, establishing a firm evidence-based foundation for a practice that has been a notable gray area in the field.

"Rigorous evaluation of blood quality is essential to understanding how blood return can be thoughtfully integrated into PE intervention," said Dr. Bulman of Beth Israel Deaconess Medical Center. "These results establish a comprehensive scientific foundation needed to balance effective clot removal with responsible blood management."

This validation is critical because significant blood loss can be a major concern during aspiration thrombectomy procedures. Minimizing this loss without compromising patient safety could reduce the need for blood transfusions, which carry their own inherent risks and costs. By providing robust data on the quality of returned blood—analyzing factors like hemolysis (red blood cell damage)—the Hēlo system's performance could set a new benchmark for safety and physiological responsibility during PE treatment.

A Complete Picture to Guide Real-World Practice

Building on the safety data, the second late-breaking presentation at SCAI will unveil the full dataset from the ENGULF IDE study. Dr. Andrew J. Klein, also a National Co-Principal Investigator from Piedmont Hospital, will present a detailed comparison of patient cohorts treated with and without the use of blood return. This head-to-head analysis within a single, prospective trial is a powerful study design that offers unique insights into how different procedural strategies affect patient outcomes.

The presentation will highlight differences in procedural characteristics, safety profiles, and clinical effectiveness between the two approaches. This level of granular detail is designed to empower physicians with the evidence needed to make more informed decisions in real-world clinical settings.

"The complete ENGULF dataset provides physicians with insight into how procedural strategy impacts outcomes in patients with pulmonary embolism," stated Dr. Klein. "By directly comparing blood return and non–blood return approaches within a single prospective trial, we can identify meaningful differences in safety, efficiency, and clinical effectiveness that inform real-world practice decisions."

These new, comprehensive findings build upon a strong foundation. Previous analyses from the ENGULF study, presented at the VIVA 2025 conference, had already demonstrated low rates of adverse events and a significant reduction in the RV/LV ratio—a key measure of right heart strain. These initial results supported the efficacy of the Hēlo system's single-pass treatment strategy, which suggests greater procedural efficiency and potentially less trauma to the patient's vasculature.

Navigating a Competitive and Expanding Market

The announcements from Endovascular Engineering arrive at a pivotal moment for the PE treatment market. The global mechanical thrombectomy device sector is experiencing robust expansion, with market projections estimating its value will surpass $2.6 billion by 2030, driven by an aging population, rising incidence of thrombotic disorders, and a strong preference for minimally invasive procedures.

In this dynamic environment, E2 faces stiff competition from established players like Inari Medical, with its FlowTriever system, and Penumbra, which markets the Indigo Aspiration System. To carve out a significant market share, new entrants must offer more than just effective clot removal; they need to demonstrate clear advantages in safety, efficiency, and overall value. E2's strategy appears to be centered on exactly that—using rigorous, differentiated clinical evidence as its primary competitive advantage.

By tackling the nuanced issue of blood return quality and providing a comprehensive comparative dataset, the Menlo Park-based company is positioning its Hēlo® Platform not just as another tool, but as a thoughtfully engineered solution designed to solve specific clinical challenges. The high-profile validation at two of the industry's most respected scientific meetings provides a powerful platform to build credibility and momentum ahead of a potential wider commercial launch.

"Both late-breaking presentations at SIR and SCAI demonstrate the depth and rigor of the clinical evidence supporting the Hēlo® Platform," said Dan Rose, Chief Executive Officer of E2. "We are proud to see this body of work recognized at two leading scientific meetings and believe it reflects the importance of continued innovation that's backed by clinical science in thrombectomy."

This focus on science-backed innovation aligns with broader trends in PE management. Recent guidelines from organizations like the American Heart Association emphasize risk stratification and more personalized treatment pathways. Devices that are supported by robust data demonstrating both efficacy and enhanced safety are well-positioned to become integral parts of these evolving care protocols, offering clinicians the confidence to optimize treatment for each individual patient. The comprehensive evidence package from the ENGULF study appears tailored to meet this growing demand for data-driven decision-making in the high-stakes environment of PE intervention.