The MegaVac™ Catheter with SafeSeal™ Technology utilizes minimal outward radial force along with the patient’s own blood pressure to safely seal the target work zone from intervening flow while naturally holding its position against the vessel wall. The MegaVac™ Mechanical Thrombectomy System allows physicians to work continuously without blood flow interference.
Working as the mechanical embolectomy element of the MegaVac™ Mechanical Thrombectomy System, the ThromboWire™ Clot Retractor is deployed distal to the target lesion and is intended to gather, collect, and retract matter towards the MegaVac™ Catheter. When combined with the large-mouth funnel aspiration of the MegaVac™ Catheter with SafeSeal™Technology, the system provides a comprehensive approach to the removal of embolic and thrombotic material.
Notable to the MegaVac™ Mechanical Thrombectomy System, the MegaVac™ Catheter with SafeSeal™ Technology creates a wide-mouth channel to address problematic lesions. The large 0.060” internal diameter provides for optimal aspiration and is a smooth conduit for the physician to deliver fluids or to intervene with lesion disruption devices such as the ThromboWire™ Clot Retractor. Due to this wide-mouth channel, the MegaVac™ Mechanical Thrombectomy System is optimized for the retrieval of embolic and thrombotic materials.
The MegaVac™ Mechanical Thrombectomy System is made up of three overarching proprietary technologies:
Together these technologies work together to retrieve embolic and thrombotic materials.
Designed to employ a unique atraumatic funnel tip that functions as an occlusive membrane within the vessel, when deployed the mouth of the MegaVac™Catheter with SafeSeal™ Technology creates a seal and secures its position within the vessel by primarily using the patient’s blood pressure and a small amount of outward radial force.
Working as the mechanical embolectomy element of the system, the primary function of the ThromboWire™ Clot Retractor is to pull thrombus into the funnel mouth of the MegaVac™ Catheter so that it can be removed and used to pull the thrombus up the catheter shaft and into the syringe.
The MegaVac™ Catheter with SafeSeal™ Technology has nominal inherent outward radial force that is less than the force on the vessel wall needed to occlude. The remainder of the force needed to occlude the vessel is done with the patient’s own blood pressure. As the occlusion funnel is opened, blood flows through the open portion of the braid and presses the silicone coating parachute portion of the braid open. This causes the leaves of the funnel to safely press against the vessel wall with SafeSeal™ Technology.
Balloons tend to exceed the optimal occlusion pressure as there is no known endpoint for occlusion other than injecting contrast into the vessel (a trial and error approach), hence often times balloons are inflated beyond the optimal sealing pressure to ensure a seal.
With negligible outward radial force there is a lower potential to damage the vessel. Histological sections have shown the MegaVac™ Catheter with SafeSeal™ Technology does not leave any visible evidence that it has been deployed.
The following provides a brief overview of how the MegaVac™ Mechanical Thrombectomy System works:
Position the MegaVac™ Catheter proximal to target clot and deploy. The distal end of the MegaVac™ Catheter with SafeSeal™ Technology occludes the vessel and arrests blood flow. Stoppage of blood flow encumbers clot fragments from traveling downstream, a critical aspect of what makes the MegaVac™ Mechanical Thrombectomy System unique to other therapies.
Once deployed, clot is aspirated through the MegaVac™ Catheter using a VacLok® syringe. Since blood flow has been arrested, the aspiration efficiency is higher than can be achieved with existing technologies and simple aspiration catheters.
If there is residual clot after the initial aspiration, the ThromboWire™ Clot Retractor is inserted through the MegaVac™ Catheter through (distal to) clot and deployed. While aspirating with the MegaVac™ Catheter, the ThromboWire™ Clot Retractor is simultaneously retracted pulling it into the MegaVac™ and out of the body.