Endovascular Engineering (E2) has secured a dual US Food and Drug Administration (FDA) clearance for Hēlo Return’s use alongside its venous thromboembolism (VTE) catheter.
E2 asserted that Hēlo Return ‘completes’ its foundational VTE platform by providing workflow-integrated blood return when used with its Hēlo thrombectomy platform. The foundational Hēlo platform secured FDA clearance in December 2025.
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Return is a component designed to collect and filter a patient’s aspirated whole blood during VTE procedures such as pulmonary embolism (PE) removal, meaning the filtered blood is safe to be returned to the patient. The aspiration system is also intended to reduce blood loss during VTE procedures, for which perioperative bleeding is a key concern, with this risk more pronounced given the standard administration of blood thinners to stop existing clots from further growth.
According to the E2, Return led to “near-zero” blood loss during the company’s ENGULF pivotal trial (NCT05597891), with FDA clearance rendering it the first blood‑return system cleared for use with continuous vacuum aspiration.
Return’s FDA clearance reflects a culmination of its efforts spent creating a “unique and complete” platform that addresses the “procedural limitations physicians currently experience when treating PE”, said E2 CEO Dan Rose.
“Physicians have communicated their needs clearly: large-bore clot removal performance in a low-profile catheter, with a single pass procedure and integrated blood return capability. With dual FDA clearances in hand, we are accelerating our plans to deliver this complete solution to a broad range of physicians and patients,” Rose continued.
Following the Hēlo thrombectomy system’s initial FDA clearance late last year, E2 has been focused on commercialisation designates for the offering. The California-based company completed an $80m Series C financing round in April, bringing its total funds raised to date to around $138m.
VTE is determined to be the leading cause of preventable hospital death in the US, as per the US Centers for Disease Control and Prevention (CDC), with the condition representing the fifth most frequent reason for unplanned hospital readmissions after surgery.
In the medtech space, alongside E2, more companies are developing products intended to make VTE treatment easier to perform and safe. With this in mind, the space is also on a considerable growth curve, with the global thrombectomy devices market growing at a CAGR of 5.5% and projected to almost double its existing valuation to around $6bn in 2035, as per GlobalData analysis.
Amply demonstrating the field’s perceived ongoing value, recent years have seen some of the highest-value deals seen in the medtech space within the past decade. Stryker completed its $4.9bn acquisition of VTE specialist Inari Medical in February 2025, while Boston Scientific agreed to acquire Penumbra in a $14.5bn deal in January 2026.
