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The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: · Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy in thromboembolic disease · Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced · Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach. The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions: · Pulmonary thromboembolism when anticoagulants are contraindicated · Failure of anticoagulant therapy in thromboembolic disease · Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced · Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entional Procedure for Filter Retrieval" in patients who no longer require a filter in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC). The Option™ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach. The self-centering Option™ELITE Filter is laser cut from nickel - titanium alloy (Nitinol) tubing. The Option™ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity. The constrained Option™ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration. The introduction kit is comprised of a filter housed in a filter cartridge. Catheter Sheath Introducer (5F ID). Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker. The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

The TLAB® Transvenous Liver Biopsy System is intended to be used for percutaneous transjugular and transfemoral venous liver access during diagnostic and interventional procedures.

The TLAB® Transvenous Liver Biopsy System is a single use, disposable, sterile device. The TLAB® Transvenous Liver Biopsy System consists of the following components: 18-Gauge (18Ga) Flexcore Biopsy Needle, 7 French (7Fr) Introducer Sheath with a curved metal stiffener, 5 French (5Fr) Straight Catheter, 5 French (5Fr) Curved Catheter, Tissue Removal Swabs, Bending Tool (used for transfemoral access).

The Cleaner™ Plus 18F Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ 18F Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement. The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes an aspiration control and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the external vacuum reservoir with pump known as the Aspiration Canister. The system is inserted percutaneously into the vessel using an introduction catheter, the system Aspiration Catheter and Dilator may be placed over-the-wire to the site of thrombus. The device macerates intra-lumen and wall adherent thrombus with a maceration wire. The macerated thrombus is removed from the vessel using an aspiration system. The aspiration of the clot can be performed simultaneous or independently. Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.

The Cleaner™ Pro Thrombectomy System is indicated for the removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature, and for the infusion of physician-specified fluids, including thrombolytics. The Cleaner™ Pro Thrombectomy System is not intended for use in the pulmonary vasculature for treating of pulmonary embolism.

The Cleaner Pro Thrombectomy System is a single use device in the removal of fresh, soft emboli and thrombi and for the infusion of physician-selected fluids through the side-port of the aspiration catheter. The disposable system consists of: (1) the Aspiration Catheter with Dilator, (2) the Handpiece with Flushing Adapter, and (3) the external vacuum reservoir with pump known as the Aspiration Canister. The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the target site. Once in the target site, to complete the system, the Aspiration Canister is connected to the handpiece. The dilator is removed, and the device is activated by the user to aspirate soft emboli and thrombi. The clot is aspirated from the distal portion of the device through the handpiece and then collected in the aspiration canister reservoir. Additionally, the device may be used for infusion of thrombolytics and/or contrast media. Once thrombus resolution is achieved, the device is removed from the patient and discarded.

The 10F Sheath and Dilator Set is indicated for introduction of therapeutic devices into the vasculature, excluding coronary and neuro vasculature.

The 10F Sheath and Dilator Set is designed for single use and intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. The 10F Sheath and Dilator Set consists of a 10F reinforced Introducer Sheath and a matching 10F radiopaque Dilator. The 10F Introducer sheath is a coil reinforced sheath with a Platinum Iridium radiopaque marker band. The sheath has a hemostasis valve and a side port with stopcock. The 10F dilator is made of radiopaque, non-reinforced material with an atraumatic tip to minimize blood loss. The device does not include any coating.

Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.

The Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are single use devices. The disposable system consists of: [A] 9F (ID) Inner Sheath, [B] 11F (ID) Outer Sheath, [C] 8F (OD) Dilator, [D] Hemostasis Valve with Sideport, [E] High Pressure Stopcock, [F] 7F [2.4mm] (OD) x 76cm Snare Catheter with Tuohy-Borst Y-Port Adapter, 20mm x 93cm Single-Loop Snare (fully expanded) or 30mm x 93cm Triple-Loop Snare (fully expanded) with Torque Handle. The snares have radiopaque loops and are preloaded in the snare catheter. The snare catheter, inner sheath, and outer sheath have a radiopaque marker band at the distal tip for enhanced fluoroscopic visualization.

The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the wire device placement. The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister. The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Mechanical thrombectomy is achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.

The Cleaner Plus™ Thrombectomy System is indicated for mechanical de-clotting, aspiration, and controlled and selective infusion of physician-specified fluids. including thrombolytics, in the peripheral venous vasculature.

The Cleaner Plus™ Thrombectomy System is a single use device used to provide thrombectomy in the peripheral venous vasculature. The device provides additional features, such as aspiration and over-the-wire device placement. The disposable system consists of: (1) the Aspiration Catheter & Dilator, (2) the Handpiece that includes system controls, and an integrated Maceration Wire, and a Peel-Away Introducer and (3) the Aspiration Canister. The Aspiration Catheter with Dilator may be placed over-the-wire to navigate the device to the therapeutic site. The dilator and guidewire are removed, and the Maceration Wire, using the Peel-Away introducer is advanced through the hemostasis valve of the Aspiration Catheter to the therapeutic site and connected to the handpiece. To complete the system, the provided Aspiration Canister is connected to the handpiece to provide aspiration. The Handpiece provides controls to turn on/off maceration and/or the application of suction. Like the current Cleaner15/CleanerXT devices, mechanical thrombectomy will be achieved by rotating a flexible stainless-steel maceration wire powered by a motor inside the handpiece. The aspiration source is provided to aspirate macerated clot from the distal portion of the device through the handpiece and captures the macerated clot in the Aspiration Canister reservoir. The Aspiration Canister includes a switch to initiate the pump, and LEDs that indicate the level of the vacuum.

The Scorpion Portal Vein Access Sets are intended for transjugular liver access in diagnostic and interventional procedures.

The Scorpion Portal Vein Access Sets have two models. One model has a Stylet as the puncture tool and the other model has a 17ga Needle as the puncture tool. The Scorpion Stylet Portal Vein Access Set contains a 10F Introducer Sheath, a 10F Dilator, a 5F MPA catheter, a 14ga Stiffening Cannula, a 0.040" Nitinol Stylet with a 5Fr PEEK Catheter, and a 7F Cannula Sheath. The 14ga stiffening cannula with cannula sheath has a directional handle that indicates the direction of the curve. The 10F Introducer Sheath hemostatic valve is designed to be compatible with up to 13F (4.3mm/0.171") sleeve. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Scorpion Stylet Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp puncture tool (0.040" Stylet) through the parenchyma. The puncture tool (Stylet) is used to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for a larger sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Scorpion Stylet Portal Vein Access Set components are removed. The Scorpion Needle Portal Vein Access Set contains a 10F Introducer Sheath, a 10F Dilator, a 5F MPA Catheter, a 13ga Scorpion Stiffening Cannula, 17ga Nitinol Needle, a 6.2F PEEK Catheter, and 8F Sheath Introducer. The 13ga stiffening cannula with cannula sheath has a directional handle that indicates the direction of the curve. The 17ga Nitinol Needle has a directional handle that indicates the direction of the 10F Introducer Sheath hemostatic valve is designed to be compatible with up to 13F (4.3mm/0.171″) sleeve. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Scorpion Needle Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp puncture tool (17ga Needle) through the parenchyma. The puncture tool (Needle) is used to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for a larger sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Scorpion Needle Portal Vein Access Set components are removed. A Portal Vein Access Set is typically in use in procedures up to 4 hours.

The Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

Halo™ Single-Loop Microsnare Kit contains: (1) Microsnare, (1) Microsnare Catheter, (1) Introducer and (1) Torque Handle. The microsnare is constructed of a flexible and radiopaque loop. The pre-formed microsnare loop can be introduced through the microsnare catheter without risk of microsnare deformation because of the snare's super-elastic construction. The microsnare catheter is constructed of flexible tubing and contains a radiopaque marker band.