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The Zoom 7X Catheter, with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing, and the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (7X, 71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The Zoom™ 7X Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the Zoom Aspiration Pump, using the Zoom Aspiration Tubing or the Zoom POD Aspiration Tubing. The Zoom 7X Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of the Zoom 7X Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy. The Zoom 7X Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices. The Zoom 7X Catheter is also packaged with two (2) introducer sheath accessories. The introducer is intended to assist with insertion of the Zoom 7X Catheter into the RHV or the guide catheter. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom 7X Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing is made of common medical grade polymers.

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 16F 82cm 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 16F 82cm 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 Standard Dilator - 24F Symphony Advance™ Long Dilator - 24F Symphony ProHelix™ - 16F Symphony Catheter - 16F Symphony Dilator - 16F Symphony ProHelix™ - Symphony Clot Container - TRUVIC Generator - TRUVIC Canister - TRUVIC Tubeset The Symphony™ 16F 82cm Thrombectomy System is comprised of several devices: - 16F 82cm Symphony Catheter - 16F 82cm Symphony Length Matched Dilator - Symphony Clot Container - TRUVIC Generator - TRUVIC Canister - TRUVIC Tubeset Both Systems are designed to remove thrombus/embolus (also referred to as '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 16F Symphony Catheter or through the 24F Symphony Catheter. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter. 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 a Symphony 16F Catheter or a Symphony 24F Catheter to assist with thrombus removal. The Symphony ProHelix is not used with the 16F 82cm Symphony Catheter. 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 Zoom System, when used with the Zoom Aspiration Pump (or equivalent vacuum pump), is indicated for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of last known well. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing are intended to connect the Zoom (71, 55, 45, 35) Catheter and the TracStar LDP Large Distal Platform, the Zoom 88 Large Distal Platform, or the Zoom 88 Large Distal Platform Support to the Zoom Canister of the Zoom Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow.

The Imperative Care Zoom System consists of the following devices: - Zoom Catheters - o Zoom™ (71, 55, 45, 35) Catheters - Large Distal Platform Catheters (LDP Catheters) ● - Zoom™ 88 Large Distal Platform™ (Zoom 88 LDP) o - Zoom™ 88 Large Distal Platform™ Support (Zoom 88 LDP Support) O - TracStar™ LDP Large Distal Platform™ (TracStar LDP) O - Zoom Aspiration Tubing and Zoom POD Aspiration Tubing - Zoom Aspiration Pump ● The Zoom Catheters and the LDP Catheters are intended to be used as a system in conjunction with the Zoom Aspiration Tubing or Zoom POD Aspiration Tubing and the Zoom Aspiration Pump (or equivalent vacuum pump) to aspirate thrombus in patients with acute ischemic stroke. The Zoom Catheters and LDP Catheters are single lumen, braid and coil reinforced, variable stiffness catheters with a radiopaque marker and a lubricious hydrophilic coating on the distal portion of the catheter. The catheters have a luer hub on the proximal end. Dimensions for each catheter are included on the individual device label. The Zoom Catheters are compatible with 0.014" - 0.018" guidewires. The LDP Catheters are compatible with 0.038" or smaller guidewires. An additional support catheter may be used to assist in accessing the target vasculature. The Zoom 45, 55, and 71 Catheters are compatible with 6F guide sheaths with a minimum inner diameter of 0.088". The Zoom 35 Catheter is compatible with 5F guide sheaths with a minimum inner diameter of 0.068". The LDP Catheters are compatible with 8F or greater introducer sheaths with a minimum inner diameter of 0.115". The Zoom 71 Catheter is compatible with 5F microcatheters or intermediate catheters with a maximum outer diameter of 0.065". The Zoom 45 and 55 Catheters are compatible with 2.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.031". The Zoom 35 Catheter is compatible with 1.4F microcatheters or intermediate catheters with a maximum outer diameter of 0.018". The LDP Catheters are compatible with 6F microcatheters or intermediate catheters with a maximum outer diameter of 0.083". All catheters are packaged with an accessory rotating hemostasis valve (RHV). The RHV is intended to be attached to the proximal hub of the catheter and used to control hemostasis during use with other devices. The Zoom Aspiration Tubing and the Zoom POD Aspiration Tubing (Zoom POD) are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the Zoom Catheter and the LDP Catheter and a slip fit connector that connects to the canister on the aspiration pump. The Zoom Aspiration Tubing and Zoom POD Aspiration Tubing are made of common medical grade polymers. In addition to the accessories discussed above, the adjunctive devices and supplies listed below could be used with the Zoom System. - Guidewires - Support/Diagnostic Catheters - Introducer Sheaths - Aspiration Pump* - Capable of achieving pressure between -20inHg to max vacuum (-29.9 inHg) - 0 Airflow rating of 0 23 LPM - 0 IEC 60601-1 Compliant * Imperative Care offers the Zoom Aspiration Pump which meets the indicated criteria.

The TracStar LDP Large Distal Platform is indicated for the introduction of interventional devices into the peripheral. coronary, and neuro vasculature. The Zoom 88 Large Distal Platform and Zoom 88 Large Distal Platform Support are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform™ (LDP) Catheters include the Zoom™ 88 Large Distal Platform™, Zoom™ 88 Large Distal Platform™ Support, and TracStar™ LDP Large Distal Platform. The LDP Catheters are 0.038" diameter or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The LDP Catheters have an inner diameter (ID) of 0.088" (6F compatible), and a maximum outer diameter (OD) of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

The Zoom 6F Insert Catheters are indicated for use in delivering radiopaque media to selected sites in the peripheral vascular system in conjunction with routine diagnostic procedures.

The Imperative Care Zoom™ 6F Insert Catheters are single lumen, braid reinforced, variable stiffness catheters. The catheters feature a standard luer hub on the proximal end, a radiopaque distal shaft and tip, and a tapered distal tip provided pre-shaped with various curve configurations. The curve configurations are designed to selectively engage arteries from the access sites such as the femoral, radial, and brachial arteries. The Zoom 6F Insert Catheter outer diameter is 0.082" (2.08 mm), the inner diameter is 0.041" (1.04 mm), and the tapered distal tip outer diameter is 0.061" (1.55 mm). The catheters are offered in working lengths of 137 cm, 139 cm, 140 cm, and 143 cm and come in three different tip configurations: VRT, SIM and VTK. The Zoom 6F Insert Catheters are compatible with standard luer lock devices (e.g., syringes), ≤ 0.038" diameter guidewires, ≥ 180 cm length guidewires, ≥ 6F introducer sheaths and ≥ 0.088" inner diameter guide catheters.