BETA
Menlo Park, California medical-device company commercializing Hēlo thrombectomy technology for pulmonary embolism and venous clot removal.
Endovascular Engineering, known as E2, was founded in 2019 by Luis Savastano and is based in Menlo Park, California. CEO Dan Rose joined in August 2024. The company develops catheter-based clot-removal systems for venous thromboembolism, serving interventional specialists and hospital procedural teams.
Its current Hēlo offering combines aspiration with mechanical clot disruption and is marketed alongside Hēlo Return for collection and filtration of aspirated blood. FDA clearance K252956 covers the Hēlo PE system. On October 12, 2026, E2 announced dual platform clearances; the newer announcement remains company-reported pending direct FDA-record matching. Separately verified Hēlo Max and earlier Cobra clearances are retained with unresolved current availability.
E2 announced a $42 million Series B in February 2025 and an $80 million Series C in April 2026. Its sponsor-run ENGULF study is registered as completed, single-arm and unmasked. Company-reported blood-return results apply to a 40-patient subgroup, not the whole registry enrollment or a head-to-head comparison. Revenue and independently verified commercial procedure volumes remain unconfirmed.
Current Hēlo: FDA Class II, 21 CFR 870.5150, QEW/KRA, K252956 December 18, 2025. October 12 platform update is distinguished from independently matched decisions. [10][6][16][11][9][1][7][19]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [21][22]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Catheter platform combining aspiration with mechanical clot disruption for venous thromboembolism intervention. [17]
FDA-clearedCurrent product offering; confirm institution-level availability with E2.
System marketed alongside Hēlo to collect and filter aspirated whole blood before return to the patient. October 12 company announcement reports FDA clearance; corresponding FDA decision not independently matched. [6]
Marketed · regulatory scope variesCurrent product offering; confirm institution-level availability with E2.
FDA-cleared larger-diameter configuration of Hēlo. Separate current commercial launch and availability not established from reviewed product page. [11]
Commercial availability not establishedFDA clearance verified; current sales status unresolved.
Earlier E2 clearance. Relationship to currently marketed Hēlo configurations and ongoing commercial availability require confirmation. [9]
Commercial availability not establishedFDA clearance verified; current sales status unresolved.
NCT05597891: registry status completed in the 2026-04-14 update; 177 participants (actual). [25]
Company reports clearances for Hēlo and Hēlo Return. New references and dates not independently matched; announcement is not counted as two additional verified FDA decisions. [6]
FDA issued K261800 for the larger-diameter configuration; launch availability not confirmed. [11]
Financing co-led by Gilde Healthcare and Norwest to support commercialization. [26]
FDA issued K252956 for the Hēlo Thrombectomy System. [10]
Appointment announced August 20, 2024; current leadership page supersedes older operating-role descriptions for other leaders. [4]
FDA issued K223891; current portfolio relationship remains unresolved. [9]
Partner release dateline April 5; page posted April 18. Not an acquisition or current exclusive distribution agreement. [3]
Cordis identifies 2019 founding by Luis Savastano, with platform development through Santé Ventures and Inventure Group. [3]
Accessed 10/29/2026