Helo Thrombectomy System

The Hēlo Thrombectomy System is a minimally invasive catheter-based device designed to remove blood clots (emboli and thrombi) from pulmonary arteries and peripheral veins using mechanical aspiration powered by a vacuum pump. The device can be introduced through a 16 Fr sheath, expands to 8 mm in the vasculature, and includes an optional agitator to mechanically disrupt clots and an audible flow indicator to provide real-time feedback during procedures.

The Hēlo System shares core design features with its predicates: single-use sterile catheter with hydrophilic coating, 16 Fr outer diameter, 95 cm working length, compatibility with 0.035–0.038 inch guidewires, rotating hemostatic valve, stainless steel agitator, vacuum pump aspiration mechanism, and radiopaque angled tip for fluoroscopic visualization. Unlike the primary predicate (Penumbra Indigo), it includes a separately packaged 9 Fr dilator and has a 6V battery-powered agitator similar to the reference predicate (Hēlo G1).

ISO 11135 (sterilization validation), ISO 10993-1 (biocompatibility), IEC 60601-1 and IEC 60601-2 (electrical safety and EMC), ASTM F1980 (accelerated aging), ASTM F1886/1886M-16 (visual inspection), ASTM F2096-11 (gross leak), and ASTM F88-21 (seal strength). Bench testing included simulated use, corrosion, clot aspiration, radial and crush force, vacuum performance, mechanical heat generation, tensile and torque testing.

The Hēlo System is substantially equivalent because it shares the same intended use (emboli and thrombi removal from pulmonary arteries and veins), principles of operation (mechanical aspiration via vacuum pump), technological characteristics (catheter-based, single-use, guidewire-compatible, with agitator and audible feedback), and anatomical site of use as the primary and reference predicates. Comprehensive bench, biocompatibility, animal, and clinical data (ENGULF study: RV/LV ratio reduction 0.40 vs. goal 0.12, p<0.001; 48-hour MAE rate 1.9% vs. goal <25%) demonstrate equivalent safety and effectiveness without new safety concerns.