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The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

The VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

The VentiV Mechanical Thrombectomy System devices are single-use, sterile, short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The System includes (1) VentiV Mechanical Aspirator and (1) VentiV 7Fr - 12Fr catheters and dilators.

The Cannula is indicated for: · the non-surgical removal of thrombi or emboli from the vasculature · aspiration of contrast media and other fluids from the vasculature The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism. The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA F186 System is comprised of six main components packaged together: - . a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip (18F) - AlphaVac Sheath (22F) - AlphaVac Obturator (17F) ● - AlphaVac Handle . - . Waste Bag and Tubing The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e., Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured and contained within the waste bag for disposal. Target vessels include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), Right Heart (Atrium (RA)), and Pulmonary Artery Vasculature. The device is provided in ~85° (AlphaVac F1885) angled configuration.

The JETiTM Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and thrombus from the peripheral vasculature and to sub-selectively infuse/deliver diagnostics with or without vessel occlusion.

The JETiTM Hydrodynamic Thrombectomy System is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETiTM Catheter, JETiTM Pump Set, JETiTM Saline Drive Unit (SDU), JETiTM Accessory Cart, JETiTM Suction Tubing, and JETiTM Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated. The JETi Catheter has two (2) lumens. The primary lumen (largest) is a conduit for thrombus aspiration. A secondary lumen, placed within the primary lumen, delivers saline through an orifice to break up and dilute the aspirated thrombus and facilitates rapid movement of the aspirate towards the vacuum. One (1) radiopaque (RO) marker band is located stiff proximal section which transitions to a more flexible distal section with a round, soft tip. A filter is incorporated into the catheter connector to ensure that no debris or foreign material is injected into the patient vasculature. The JETi Catheter is available in two sizes: 6 French size (6F) and 8 French size (8F). The JETi Pump Set is intended to deliver a high pressure sterile saline stream to the JETi Catheter. The pressure for the saline stream is created through the cassette's piston assembly, which snaps into the SDU. The JETi Saline Drive Unit (SDU) is a non-sterile reusable, (multiple patient, multiple use) device that incorporates the saline pumping components and the vacuum pump within a single enclosure. The fork drive of the SDU is designed to run the JETi Pump Set piston assembly to deliver a stream of saline to the JETi Catheter when activated by the handheld switch if the vacuum is present. In conjunction with the JETi Pump Set, the SDU can sub selectively infuse / deliver diagnostics or therapeutic fluids when utilizing the optional HYPER PULSETM Fluid Delivery feature. The JETi Suction Tubing is a sterile single use device that incorporates the pressure monitoring sensor and valve into a single enclosure, that is in-line with the aspiration lumen, for the handheld switch. When the handheld switch is activated, within the aspiration lumen, the diluted thrombus and saline is then drawn back through the primary lumen of the JETi Catheter and deposited into the vacuum source (JETi Non-sterile Canister Set) via the JETi Suction Tubing. When the handheld switch is de-activated, a valve closes, stopping the flow of thrombus, and a relief valve inside the SDU briefly opens and closes to reduce foaming at the vacuum source (JETi Non-sterile Canister Set). The SDU contains a microprocessor-controller circuit board and firmware that monitors various functions of the motor and vacuum to ensure that the device is functioning as expected. A Liquid Crystal Display (LCD) screen on the front panel of the SDU indicates to the user the status of the system. Several safety features are incorporated into the firmware to ensure proper functionality. The SDU is supported by a mobile, height adjustable cart with an integrated IV pole. Energy is provided by a 24-volt external power supply, which is connected to the main supply. The external power supply is provided with the SDU and is part of the system

The Cannula is indicated for - · the non-surgical removal of thrombi or emboli from venous vasculature. - · aspiration of contrast media and other fluids from venous vasculature. The Cannula is intended for use in the venous system. The Handle is indicated as a vacuum source for the AlphaVac MMA System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System is a single use-overwire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA F186 System is comprised of six main components packaged together: - . a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip (18F) - AlphaVac Sheath (22F) - AlphaVac Obturator (17F) ● - AlphaVac Handle . - . Waste Bag and Tubing The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e., Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured and contained within the waste bag for disposal. Target vessels include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), and Right Heart (Atrium (RA)). The device is provided in ~85° (AlphaVac F1885) angled configuration.

The JETi AIO Peripheral Thrombectomy System is intended to: - remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and - subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

The JETi All In One (AIO) Peripheral Thrombectomy System consists of one catheter, which is connected to the JETi Pump Set and JETi AIO Suction Tubing, one JETi AIO Peripheral Saline Drive Unit (SDU), and an Accessory Cart. A Non-Sterile Kit and Sterile Kit are supplied for user convenience. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum pump. Infusion is achieved by activating the Hyper Pulse® rocker switch. When in Hyper Pulse® mode, activating the handheld switch activates the SDU motor to infuse/deliver diagnostic or therapeutics to the targeted site. The peripheral SDU and pump set deliver a stream of sterile saline through the secondary lumen to break up and dilute the thrombus within the catheter. The diluted thrombus and saline are drawn back through the primary lumen and deposited into the disposable collection canister. No high pressure saline is injected into the patient during normal operation. The peripheral SDU, a height adjustable cart, a height adjustable canister mount, an IV pole, basket, and cart handle are contained on an accessory cart.

The Merit ASAP® Aspiration Catheter is intended for the removal and thrombi and thrombi from vessels of the arterial system. Not for use in cerebral vasculature. The Merit ASAPLP™ Aspiration Catheter is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial system. Not for use in cerebral vasculature.

The Merit ASAP aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm quide wires with related accessories. The catheter has a maximum outer diameter of 0.068"/1.73mm and a working length of 140 cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm, 100 cm, and 110 cm proximal of the distal tip. The distal reqion has a hydrophilic coating. The rapid exchange lumen is 12cm in length. The ASAPLP Aspiration Catheter is a dual lumen rapid exchange catheter, compatible with 0.014"/0.36 mm guide wires. It is packaged Device with related accessories including a stiffening stylet. The catheter has Description a maximum outer diameter of 0.055"/0.140 cm and a working length of 145cm. The catheter has a radiopaque marker band located approximately 2 mm proximal to the distal tip. The catheter has three (3) non-radiopaque positioning marks located approximately 90 cm. 100 cm and 110 cm proximal of the distal tip. The distal region has a hydrophilic coating. The rapid exchange lumen is 20 cm in length. The associated accessories packaged with the device include: Tubing Connector Set with (1) Large Bore Stopcock ● RXP® Rapid Exchange Prep Syringe ● (2) 30 mL VacLok™ syringes ● Microstop Waste Basin with Lid and (2) 70 Micron Pore Filter . Baskets

The Thrombuster II Aspiration Catheter is indicated for the removal and thrombi from vessels in the coronary and peripheral system. The Thrombuster II is not in the cerebral vasculature.

Thrombuster II Aspiration Catheter [Thrombuster II] is a rapid exchange type of dual lumen catheter for embolectomy. The main body consists of a distal shaft, proximal shaft, ring marker, hub, and strain relief. The catheter working length is 1400 mm. This product includes a core wire to resist kink during delivery in clinical usage, syringe kit (extension tube, stopcock, and lock syringe) for connecting the catheter main body and aspiration of fresh, soft emboli and thrombi, and accessories (flushing needle and filter). After insertion of the catheter into a patient body, this product aspirates and removes emboli or thrombi from a target lesion by transmitting negative pressure generated by connected lock syringe to the distal end of the catheter.

The Cannula is indicated for · the non-surgical removal of thrombi or emboli from vasculature. · aspiration of contrast media and other fluids from vasculature. The Cannula is intended for use in the venous system. The Handle is indicated as a vacuum source for the AlphaVac MMA System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) System is a single use-over-wire catheter- based system that facilitates the removal of thrombus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA System is comprised of six main components packaged together: - a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip - . AlphaVac Sheath - . AlphaVac Obturator - AlphaVac Handle - Waste Bag and Tubing The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e. Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured within the waste bag for disposal. Target vessels for include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), and Right Heart (Atrium (RA)). The device is provided in ~20° (AlphaVac 25F/C20) and ~180° (AlphaVac 25F/C180) angled configurations.