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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 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 aspiration 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 Accessory Device is supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum pump. 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 JETi 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 Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi Pump Set, one JETi Peripheral Saline Drive Unit (SDU), one Peristaltic Pump, and an Accessory Stand. A Sterile Accessory Kit and Non-Sterile Accessory Device are supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the peristaltic pump. 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 peristaltic pump receptacle. No saline is injected into the patient during normal operation. The peripheral SDU, peristaltic pump, an adjustable mounting arm, an accessory basket, and an IV pole are contained on an accessory stand. The peripheral catheter is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of saline via a displacement pump within the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream. The peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen. For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter. For infusion through the saline lumen, a clamp is used on the suction tubing to cut off aspirate flow. The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the multi-port Luer adapter of the peripheral catheter and delivers the saline to the peripheral catheter. The peripheral SDU is a reusable device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the foot pedal. Aspiration is achieved with a peristaltic pump that is connected to the SDU and is also turned on/off with the foot pedal. The pressure sensor is connected to the suction tubing, which is connected to the multi-port connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and pressure to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

The JETi 88 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 88 Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi 88 Pump Set, one JETi 88 Peripheral Saline Drive Unit (SDU), and an Accessory Cart. A Sterile Accessory Kit and Non-Sterile Accessory Device are supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the vacuum pump. 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 vacuum pump receptacle. No saline is injected into the patient during normal operation. The peripheral SDU, an adjustable mounting arm, a mounting bracket for vacuum canisters, an IV pole and a vacuum pump are contained on an accessory cart. The peripheral catheter is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of saline via a displacement pump within the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream. The peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen. For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter. For infusion through the saline lumen, a clamp is used on the suction tubing to cut off vacuum. The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the multi-port Luer adapter of the peripheral catheter and delivers the saline to the peripheral catheter. The peripheral SDU is a reusable device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the foot pedal. Vacuum is achieved with a vacuum pump, turned on/off with the pinch valve on the side of the SDU, which is also controlled by the foot pedal. The vacuum sensor is connected to the vacuum tubing, which is connected to the multi-port connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

The ClearLumen II 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 ClearLumen II Peripheral Thrombectomy System is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream. The ClearLumen II Peripheral Thrombectomy System consists of one aspiration catheter, which connects to the ClearLumen II Pump Set and the ClearLumen Peripheral Saline Drive Unit (SDU). In use, thrombus enters the distal catheter tip via the suction force provided by a 60 ml VacLok syringe, which is connected to the vacuum sensor. 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 is drawn back through the primary lumen and deposited into the syringe. No saline is injected into the patient during normal operation. The ClearLumen II Peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen. For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter. For infusion through the saline lumen, a non-vented Luer cap is placed between the rotating hemostasis valve (RHV) side arm and the pressure monitor tubing. The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette, which is centered in the pump set, contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the Y-connector of the peripheral catheter and delivers the saline to the peripheral catheter. The peripheral SDU is a reusable, IV pole mounted device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user the current status of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

The ClearLumen II Peripheral Thrombectomy System is intended to remove/aspirate fluid and thrombus from the peripheral vasculature.

The ClearLumen II Peripheral Thrombectomy System is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream. The ClearLumen II Peripheral Thrombectomy System consists of one aspiration catheter, which connects to the ClearLumen II Pump Set and the ClearLumen Peripheral Saline Drive Unit (SDU). In use, thrombus enters the distal catheter tip via the suction force provided by a 60 ml VacLok syringe, which is connected to the vacuum sensor. 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 is drawn back through the primary lumen and deposited into the syringe. No saline is injected into the patient during normal operation. The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette, which is centered in the pump set, contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the Y-connector of the peripheral catheter and delivers the saline to the peripheral catheter. The peripheral SDU is a reusable, IV pole mounted device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user the current status of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

The ClearLumen II Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the coronary and peripheral vasculature.

The ClearLumen II Thrombectomy System is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream. The system is comprised of three components: The ClearLumen II Catheter, the ClearLumen II Pump Set, and the ClearLumen Saline Drive Unit (SDU). Additional off-the-shelf accessory components are required for device operation and include a vacuum syringe, one way stopcock, aspiration extension tubing and a vacuum sensor. The 6 Fr, 135 cm, multi-lumen thrombectomy catheter delivers pressurized saline, within the distal catheter inner diameter, to assist in the break-up and removal of soft emboli and thrombus. The distal catheter's 0.014" wire compatible rapid exchange lumen extends and ends in a soft atraumatic tip. The proximal in-line Luer port connects to the pump set, while the Y-connector connects to the vacuum sensor, extension tube, stopcock, vacuum syringe assembly (supplied separately). The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette, which is centered in the pump set, contains a piston pump and is mounted onto the SDU. The cassette is powered by the motor contained in the SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the Y-connector of the catheter and delivers the saline to the catheter. The SDU is a reusable, IV pole mounted device. The fork drive of the SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the catheter, when activated by the vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-connector of the catheter. The SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user what the current status is of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.

The ClearLumen Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the coronary and peripheral vasculature.

The ClearLumen Thrombectomy System consists of a thrombectomy catheter, saline drive unit ("SDU") and aspirate collection vacuum bottles. The 6 Fr, 135 cm, multi-lumen thrombectomy catheter delivers pressurized saline, within the distal catheter I.D., to assist in the break-up and removal of soft emboli and thrombus. The distal catheter's .014″ wire compatible rapid exchange lumen extends and ends in a soft atraumatic tip. The catheter's proximal polycarbonate hub connects to the SDU and provides coaxial access to the infusion and aspiration lumens. The ClearLumen Catheter is connected to the battery operated SDU, which includes a pump to generate pressurized saline and conduit/collection of aspirate. The SDU uses a toggle switch to turn the pump on and off and actuate a valve in line to a pre-charged vacuum bottle (aspiration source). The SDU connects via spike to a standard saline bag (saline source).