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The Aventus Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Aventus Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from pulmonary arteries, the peripheral vasculature and/or infusing fluids. The System is comprised of the following major components:

• Aventus Thrombectomy Catheter
• Clot Management System consisting of:
  • Aspiration Syringe
  • Clot Canister

The System is compatible with a standard 24-French (24F) introducer sheath, Navigation Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.

The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics.

The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness, and includes a hydrophilic coating applied to the outside of the catheter shaft.

The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

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