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The MegaVac Mechanical Thrombectomy System is indicated for: - The non-surgical removal of emboli and thrombi from blood vessels. - The non-surgical removal of thrombi from synthetic grafts. - Use in temporary blood vessel/graft occlusion. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft - Catheter placement over a guidewire

The MegaVac Mechanical Thrombectomy System consists of two single-use devices, the MegaVac Catheter with SafeSeal technology and a ThromboWire clot retractor, for intravascular mechanical thrombectomy, occlusion, aspiration and embolectomy. The MegaVac Catheter with SafeSeal technology utilizes a silicone coated nitinol braided funnel that expands to occlude antegrade blood flow proximal to the target work zone creating a static environment in which to perform the intervention, while also centering and securing the catheter tip position within the vessel. The MegaVac catheter's large-mouth funnel and inner diameter allows for strong aspiration while easily being able to pass the ThromboWire and other lesion disruptive or therapeutic devices through it. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle can serve to gather and pull matter towards and through the MegaVac catheter during aspiration.

INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. INDIGO Aspiration Tubing As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vessels by aspirating the proximal side of the thrombus using the Aspiration Catheter, Separator, and Aspiration Tubing. The Penumbra Aspiration System components were originally cleared under K161506. The Penumbra Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, the Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and the Pump Canister/Tubing. The Aspiration Catheter is provided with a rotating hemostasis valve and an introducer sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheters and Separators are visible under fluoroscopy. The CAT RX Aspiration Catheter is a dual lumen, rapid exchange, intravascular catheter. It is designed and composed of materials common to interventional devices. The distal lumen is PTFE lined and the shaft is reinforced with both nitinol round wire and a flexible laser cut stainless steel hypotube. The shaft has variable stiffness with progressively softer polymer extrusion materials moving distally along its length. The distal portion of the shaft is hydrophilically coated for lubricity. The distal tip has a radiopaque platinum/iridium markerband. The CAT RX Aspiration Catheter is available in effective lengths ranging from 120cm to 160cm and is provided sterile for single use. The CAT RX Aspiration Catheter is packaged in a kit with the Aspiration Tubing. The kit also contains a rotating hemostasis valve (RHV) and introducer sheath. The Aspiration Tubing connects the Penumbra Aspiration Pump to the CAT RX Aspiration Catheter within the sterile field. The Aspiration Tubing has a flow valve which connects directly to the CAT RX Aspiration Catheter hub or RHV and allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is provided sterile, and is available either individually packaged or in a kit with the CAT RX Aspiration Catheter.