Your solution to deep vein thrombosis and pulmonary embolism
Innovations & Impacts
The Hydra Catheter Thrombectomy System is a next generation, multi-modal venous thrombectomy device designed to treat acute large-volume DVTs. The device is the first device to overcome the limitations of previous generation devices, all of which lead to significant peri-procedural morbidity and mortality in patients affected by large-volume DVT.
The Hydra Catheter Thrombectomy System combines mechanical, chemical, and suction thrombectomy features for efficient fragmentation and evacuation of venous blood clots, and does so safely by isolating the thrombolytic drugs and thrombus microemboli within a defined treatment zone. The treatment zone is then cleared of these drugs and microemboli before venous flow is restored to the segment. These would improve clinical thrombectomy outcomes while limiting the risk of vein wall trauma, distal microembolization, peri-procedural blood loss. Specifically the device features:
Double balloon occlusion: The compliant proximal and distal balloons serve two main purposes. First, they help define the venous treatment zone and encapsulate the thrombosed segment. This ensures that the thrombolytic drugs and thrombus microemboli that cause major peri-procedural morbidity with other devices can be removed from the patient prior to completion of the procedure. Second, the complaint balloons also act as anchors for the device to avoid shifting or movement of the device during the procedure.
Rail-mounted leaflet agitator: The novel leaflet agitator is uniquely designed to provide a mechanism for venous thrombus fragmentation, engagement, and traction back into the negative suction port. The agitator is designed to advance and retract on a rail that will remain near the center-line of the vein, and avoid the rubbing of the venous wall.
Isovolumetric infusion and suction: The Hydra Catheter Thrombectomy System is the only system to include a mechanism to allow for isovolumetric infusion and suction to flush thrombus fragments from the treatment zone. This unique feature overcomes a major source of morbidity in other existing devices by avoiding venous wall distension or collapse during treatment.
Competitive Advantage: Using an evidence-based approach, the Hydra Catheter Thrombectomy System device is engineered to be a “next-generation” device. It builds upon our experience with other thrombectomy device categories, and clinical trial outcomes. These indicate that although chemical thrombolysis, mechanical thrombectomy, and negative suction thrombectomy can treat DVT, they are not effective in a single treatment session when applied independently. Additionally, clinical trial findings indicate that current devices are associated with unacceptably high risk of peri-procedural bleeding, vein wall damage, and distal thrombus emboli into the pulmonary arteries. The Hydra Catheter Thrombectomy System device is specifically designed to reduce all of these risks, improve patient outcomes, and enhance the standard of care.