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The Symphony Thrombectomy System is intended for: - · The non-surgical removal of fresh, soft emboli and thrombi from blood vessels. - · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Symphony Thrombectomy System is intended for use in the peripheral vasculature. It is not for use in the pulmonary vasculature.

The Symphony Thrombectomy System is comprised of several devices: • 24F Symphony Catheter • 24F Symphony Dilator • 24F Symphony Advance™ Long Dilator • 24F Symphony ProHelix™ • 16F Symphony Catheter • 16F Symphony Dilator • 16F Symphony ProHelix™ • TRUVIC Generator • TRUVIC Canister • TRUVIC Tubeset The Symphony Thrombectomy System is designed to remove thrombus/embolus (also referred to as 'thrombus' or 'clot') from the peripheral vasculature using controlled aspiration. The Symphony Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the Symphony Catheter. The Symphony Catheter has a lubricious hydrophilic coating on the distal 40 cm of the 24F catheter shaft, and distal 55 cm of the 16F catheter shaft. The Symphony Catheters and Symphony Dilators are introduced through a vascular access sheath into the peripheral vasculature and guided over a guidewire to the site of the thrombus. The Symphony Catheter is used with the TRUVIC Generator, connected using the TRUVIC Tubeset and the TRUVIC Canister, to aspirate thrombus. As needed, the Symphony ProHelix may be introduced through the Symphony Catheter to assist with thrombus removal. The Symphony ProHelix is manually advanced through the Symphony Catheter over a guidewire, remaining inside the Symphony Catheter during the procedure. During aspiration, the handle on the proximal end of the Symphony ProHelix is manually rotated, which rotates the tip of the Symphony ProHelix to facilitate thrombus removal through the Symphony Catheter. The tips of the devices are visible under fluoroscopy.

The Prodigy™ Thrombectomy System is intended for the removal and thrombi and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries, pulmonary vasculature, or the neurovasculature

The Prodigy™ Thrombectomy System is designed to remove thrombus from the vasculature using aspiration. The Prodigy™ Thrombectomy System is comprised of several components including: - . Prodigy™ Catheter - . Prodigy™ Twist - . Prodigy™ Hotshot™ Controller - TRUVIC Generator - TRUVIC Canister - . TRUVIC Tubeset The single-lumen Prodigy™ Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The wire-based Prodigy™ Twist utilizes a soft, flexible polymeric tip to facilitate thrombus removal through the Prodigy™ Catheter as needed. The Prodigy™ Catheter is available in multiple diameters and both the Prodigy™ Catheter and Prodigy™ Twists are available in multiple effective lengths and are visible under fluoroscopy via radiopaque marker bands. The Prodigy™ Hotshot™ Controller connects the Prodigy™ Catheter to the TRUVIC Generator and provides the user with the ability to control aspiration flow and visualize the extracted thrombus.