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RF3000 Radiofrequency Ablation System

Simplicity and Predictability in Soft Tissue Ablation.

Boston Scientific's RFA system uses a deployable LeVeen needle electrode needle to accurately capture tumors and form a stable, wide thermocoagulative necrosis zone.

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Designed for use with the RF3000 Radiofrequency Generator
  • Umbrella-shaped array
  • Wide portfolio matrix of array diameters from 2cm to 5cm
  • Soloist Single Needle Electrode for small 1.5cm x 1cm ablation zones
  • The only RFA system that utilizes impedance to accurately assess the procedural endpoint
Variety of Cannula Designs
  • LeVeen SuperSlim needle electrode intended to minimize invasiveness
  • CoAccess Needle Electrode System enables a coaxial entry port for one or multiple insertions, including biopsy probe access
  • Depth markings at 1cm intervals designed for accuracy of placement

 

RF3000 Radio Frequency Generator

The RF 3000 Radio Frequency (RF) Generator is intended for thermal coagulation of soft tissue with electrodes separately cleared by the United States FDA. The generator delivers an isolated RF output of up to 200 watts to the electrode. Full power is available in the impedance range of 25Ω to 100Ω at a constant RF voltage; lower powers are available outside this range. Power can be adjusted manually; however, changes in load impedance will change the actual power delivered (a safety feature described more fully in “Passive Power Limitation”). When power is on, actual delivered RF power and impedance are displayed. The Operation and Service Manual is intended as an instructional guide only.

LeVeen Needle Electrode Family

INTENDED USE/INDICATIONS FOR USE

The LeVeen Needle Electrode Family is intended to be used in conjunction with the RF 3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions. These procedures should only be performed by physicians and staff familiar with the equipment and techniques involved.

WARNINGS

  • The colored insulated cannula must be used at all times when accessing tissue. Use of the electrode without the colored insulated cannula may result in serious burns to the patient and/or user.
  • Damage to the insulation of the introducer may result in serious burns to the patient and/or user.
  • Precaution: The LeVeen Needle Electrode Family must be used in conjunction with the Boston Scientific RF 3000 ™ Generator.
  • For patients with permanent pacemakers and Implantable Cardiac Defibrillators (ICD) additional precautions should be taken.

ADVERSE EVENTS

Reported complications associated with radiofrequency (RF) ablation of liver tissue include, but are not limited to:
  • Abscess
  • ARDS (Acute Respiratory Distress Syndrome)
  • Arrhythmia
  • Ascites
  • Biloma
  • Burn
  • Death
  • Delayed hemorrhage into ablated tissue
  • Diarrhea
  • Electric Shock
  • Fistula, including biliary fistula
  • Hematoma
  • Hemorrhage
  • Infection
  • Liver Failure
  • Liver Insufficiency
  • Pain
  • Perforation
  • Peritonitis
  • Persistent Fever > 39° C
  • Pleural Effusion
  • Renal Failure
  • Tumor Recurrence
  • Tumor Seeding

Soloist Single Needle Electrode

INTENDED USE/INDICATIONS FOR USE

The Soloist Single Needle Electrode is intended to be used in conjunction with the RF 3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

WARNINGS

  • Damage to the insulation of the introducer or needle may result in serious burns to the patient and/or user.
  • Precaution: The Soloist™ Single Needle Electrode must be used in conjunction with the Boston Scientific RF 3000™ Generator.
  • For patients with permanent pacemakers and Implantable Cardiac Defibrillators (ICD) additional precautions should be taken.

ADVERSE EVENTS

Reported complications associated with radiofrequency (RF) ablation of liver tissue include, but are not limited to:
  • Abscess
  • ARDS (Acute Respiratory Distress Syndrome)
  • Arrhythmia
  • Ascites
  • Biloma
  • Burn
  • Death
  • Delayed hemorrhage into ablated tissue
  • Diarrhea
  • Electric Shock
  • Fistula, including biliary fistula
  • Hematoma
  • Hemorrhage
  • Infection
  • Liver Failure
  • Liver Insufficiency
  • Pain
  • Perforation
  • Peritonitis
  • Persistent Fever > 39°C
  • Pleural Effusion
  • Renal Failure
  • Tumor Recurrence
  • Tumor Seeding
Product Code -
Application Radiofrequency Ablation
Manufacturer Country USA
Guarantee Type Based on manufacturer recommendations
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