Manufacturer > Rex Medical > Devices > REVOLUTION™ Peripheral Atherectomy System

REVOLUTION™ Peripheral Atherectomy System

Device-Type

Atherectomy Devices

Targated Speciality

Atherectomy

Manufacturer

Rex Medical

The RevolutionTM Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system that utilizes a diamond-coated burr spinning at 140,000 RPM for treatment. The RevolutionTM Peripheral Atherectomy System is designed for the ablation and removal of thrombus and atherosclerotic plaque from the peripheral arteries. The device is composed of a disposable hand held single piece construction drive unit that is attached to a power supply. The drive unit consists of a coaxial sheath and electrically driven drive shaft for spinning the abrasive burr. The drive shaft has a central lumen, compatible with the RevolutionTM 0.014” (.36 mm) guidewire. The catheter has 2 side ports for aspiration and infusion connections. The speed switch aids in rapid exchange of the guidewire by providing a slow spinning setting. The wire and abrasive burr are radiopaque for fluoroscopic visualization.

Features and Benefits

  •  Front Cutting
  •  Continuous Aspiration
  •  No Capital Equipment Required
  •  Ease of Setup and Use
  •  ATK and BTK Capable
  •  .014" Over-the-Wire Design


Safety informations

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

CONTRAINDICATIONS: 

The Revolution Peripheral Atherectomy System is contraindicated in the following situations:-

  • This system is contraindicated when, in the medical judgment of the physician, such a procedure may compromise the patient’s condition.
  • Occlusions through which a guidewire will not pass.
  • This system is intended only for infrainguinal peripheral artery disease and is not intended for use in coronary arteries.
  • The target lesion is within a bypass graft or stent.
  • In patients with angiographic evidence of significant dissection at the treatment site. The patient may be treated conservatively to permit the dissection to heal before treatment.
  • This device is contraindicated in patients who cannot receive recommended anti-platelet and/or anticoagulant therapy.

Potential adverse events

  • Additional Intervention
  • Allergic reaction
  • Amputation
  • Death
  • Embolism
  • Hematoma/Hemorrhage
  • Hemodynamic changes
  • Hemoglobinuria
  • Bleeding complications
  • Pain and tenderness
  • Access site injury
  • Hypotension

Device Documents

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