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Atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.

The Revolution Peripheral Atherectomy System is sterile, single-use device designed for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease. The Revolution device incorporates a flexible drive shaft designed to track over the Revolution guidewire. Attached to the distal end of the drive shaft is a diamond coated spheroid shaped burr which rotates at high speed to ablate occlusive material and restore luminal patency. Power is derived from a mains source and converted using the reusable power supply. During treatment, the rotating burr ablates material into fine particles. This particulate is conveyed proximally by a mechanical means through the catheter and handle into a collection receptacle that resides outside the patient. The device is available in 145cm, 200cm, and 60cm lengths with burr diameters of 1.33mm, 1.66mm, 2.00mm, and 2.33mm. The Revolution Peripheral Atherectomy System consists of the following components: 1. Single-use Revolution Device (provided sterile) 2. Single-use Revolution .014" Guidewire (provided sterile) 3. Single-use infusion assembly (provided sterile) 4. Single-use collection receptacle (provided sterile) 5. Single-use guidewire clip (provided sterile) 6. Reusable power supply (provided non-sterile)

The Revolution Peripheral Atherectomy System is intended for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries with occlusive atherosclerotic disease.

The Revolution Peripheral Atherectomy System is sterile, single-use device designed for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease. The Revolution device incorporates a flexible drive shaft designed to track over the Revolution guidewire. Attached to the distal end of the drive shaft is a diamond coated spheroid shaped burr which rotates at high speed to ablate occlusive material and restore luminal patency. Power is derived from a mains source and converted using the reusable power supply. During treatment, the rotating burr ablates material into fine particles. This particulate is conveyed proximally by a mechanical means through the catheter and handle into a collection receptacle that resides outside the patient. The device is available in 145cm and 60cm lengths with burr diameters of 1.33mm, 1.66mm, and 2.00mm. The Revolution Peripheral Atherectomy System consists of the following components: 1. Single-use Revolution Device (provided sterile) 2. Single-use Revolution .014" Guidewire (provided sterile) 3. Single-use infusion assembly (provided sterile) 4. Single-use collection receptacle (provided sterile) 5. Single-use guidewire clip (provided sterile) 6. Reusable power supply (provided non-sterile)

The Aspiration Pump is intended for general suction use in hospitals or clinics.

The Aspiration Pump is a portable suction / aspirator / vacuum system which is used to remove debris, blood and other bodily fluids through the application of continuous negative pressure. The Aspiration Pump includes two suction / vacuum ports on the input side, each with individual flow control valves and standard 6% Luer taper connectors. A 500cc collection bag is attached to the output side of the Aspiration Pump for collection of removed debris, blood and bodily fluids.

The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vascular.

The Cleaner™ Rotational Thrombectomy System is a percutaneous infusion system that utilizes a rotating sinusoidal wire to increase the dispersion of delivered solution. The devices employ mechanical rotation of a flexible "S" shaped dispersion wire at 4000 RPM which creates a fluid vortex within the treatment site. Contrast media and physician specified solutions, including thrombolytics, may be infused through the catheter lumen to a side hole at the distal end. The dispersion wire uses mechanical rotation to allow the infused solution to penetrate the clot increasing the effectiveness of the treatment. Any residual clot can be aspirated through an introducer sheath prior to restoration of flow. The distal soft tip is a radiopaque a-traumatic tip on the distal end of the dispersion wire. The devices are sterile and single-use disposable.