Manufacturer > Medtronic > Devices > CLOSUREFAST™ RFA SYSTEM

CLOSUREFAST™ RFA SYSTEM

Device-Type

Ablation System

Manufacturer

Medtronic


Radiofrequency Ablation for

Chronic Venous Insufficiency (CVI)

The ClosureFast procedure, with its patented overlap design, is the only RFA procedure with published long-term clinical data demonstrating safety and efficacy, with a 91.9% closure rate at 5 years.


The ClosureFast endovenous radiofrequency ablation (RFA) catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. The catheter is provided sterile, and is a single-use, disposable device. This catheter cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse, and is therefore intended for single use. Attempts to clean or sterilize these devices may result in a bio-incompatibility, infection, or product failure risks to the patient.


SYSTEM COMPONENTS 


ClosureFast Endovenous Radiofrequency Ablation Catheter


ClosureFast radiofrequency ablation catheter on light blue gradient background


  • The ClosureFast catheter precisely heats a 7 cm vein segment (or 3 cm for shorter, refluxing vein lengths) in one 20-second interval.
  • The heat provided by the catheter shrinks and collapses the target vein, creating a fibrotic seal and occluding the vessel.


ClosureFast Endovenous Radiofrequency Ablation Stylet


ClosureFast radiofrequency ablation stylet on light blue gradient background


  • The ClosureRFS™ stylet is the only intravascular ablation device specifically intended for the treatment of incompetent perforator and tributary veins.
  • This minimally invasive outpatient procedure leaves minimal scarring at the puncture site and can be either the primary treatment or an adjunct treatment using the ClosureFast catheter.


ClosureFast Radiofrequency Generator


ClosureFast generator on light blue gradient background


  • The ClosureRFG generator delivers radiofrequency energy to the ClosureFast catheter and the ClosureRFS stylet for the effective treatment of CVI.
  • The controlled feedback mechanism monitors intravascular heat parameters in real time to automatically regulate therapeutic power.


Features and Benefits

Gap-free thermal ablation

The ClosureFast RFA system delivers uniform heat for lasting vein closure.

  • Patented segmental procedure
  • Tumescent anesthesia
  • Less pain and bruising than laser energy treatment3
  • Post-procedure compression stockings required1


Disposable catheter inserted into a vein during the ClosureFast procedure

Catheter inserted into vein


Radiofrequency ablation catheter collapsing a vein with heat

Controlled heat collapses vein


Radiofrequency ablation catheter being withdrawn from a vein as it collapses after treatment with heat

Catheter withdrawn, closing vein

Safety informations

Separate use of the individual components of the VenaSeal closure system is contraindicated. These components must be used as a system. The use of the VenaSeal system is contraindicated when any of the following conditions exist: previous hypersensitivity reactions to the VenaSeal™ adhesive or cyanoacrylates, acute superficial thrombophlebitis, thrombophlebitis migrans, acute sepsis.

Potential adverse events

The potential adverse effects (e.g., complications) associated with the use of the VenaSeal system include, but are not limited to, adverse reactions to a foreign body (including, but not limited to, nonspecific mild inflammation of the cutaneous and subcutaneous tissue), arteriovenous fistula, bleeding from the access site, deep vein thrombosis (DVT), edema in the treated leg, embolization, including pulmonary embolism (PE), hematoma, hyperpigmentation, hypersensitivity or allergic reactions to cyanoacrylates, such as urticaria, shortness of breath, and anaphylactic shock, infection at the access site, pain, paresthesia, phlebitis, superficial thrombophlebitis, urticaria, erythema, or ulceration may occur at the injection site, vascular rupture and perforation, visible scarring.

Device Documents

Related Device SKUs

* Select 2 or more (upto 4) SKUs to compare.
SKU Name Device SKUs Model Introducer Sheath (minimum ID size) Insertable Length Heating Element Diameter Heating Element Length Heating Element Overlap Compatible Guidewire Maximum Power Setting Default Target Temperature Setting Software Version: RFG2 Software Version: RFG3
CLOSUREFAST™ RFA SYSTEM
CF7-7-60 7 F (2.3 mm) 60 cm 2.3 mm 7 cm 0.5 cm 0.025" 40 W 120°C 4.0.0 or higher 1.11.0 or higher
CLOSUREFAST™ RFA SYSTEM
CF7-7-100 7 F (2.3 mm) 100 cm 2.3 mm 7 cm 0.5 cm 0.025" 40 W 120°C 4.0.0 or higher 1.11.0 or higher
CLOSUREFAST™ RFA SYSTEM
CF7-3-60 7 F (2.3 mm) 60 cm 2.3 mm 3 cm 0.5 cm 0.025" 18 W 120°C 4.0.0 or higher 1.11.0 or higher
  • Model : CF7-7-60
  • Procedure : -
  • Introducer Sheath (minimum ID size) : 7 F (2.3 mm)
  • Insertable Length : 60 cm
  • Heating Element Diameter : 2.3 mm
  • Heating Element Length : 7 cm
  • Heating Element Overlap : 0.5 cm
  • Compatible Guidewire : 0.025"
  • Maximum Power Setting : 40 W
  • Default Target Temperature Setting : 120°C
  • Software Version: RFG2 : 4.0.0 or higher
  • Software Version: RFG3 : 1.11.0 or higher
  • Model : CF7-7-100
  • Procedure : -
  • Introducer Sheath (minimum ID size) : 7 F (2.3 mm)
  • Insertable Length : 100 cm
  • Heating Element Diameter : 2.3 mm
  • Heating Element Length : 7 cm
  • Heating Element Overlap : 0.5 cm
  • Compatible Guidewire : 0.025"
  • Maximum Power Setting : 40 W
  • Default Target Temperature Setting : 120°C
  • Software Version: RFG2 : 4.0.0 or higher
  • Software Version: RFG3 : 1.11.0 or higher
  • Model : CF7-3-60
  • Procedure : -
  • Introducer Sheath (minimum ID size) : 7 F (2.3 mm)
  • Insertable Length : 60 cm
  • Heating Element Diameter : 2.3 mm
  • Heating Element Length : 3 cm
  • Heating Element Overlap : 0.5 cm
  • Compatible Guidewire : 0.025"
  • Maximum Power Setting : 18 W
  • Default Target Temperature Setting : 120°C
  • Software Version: RFG2 : 4.0.0 or higher
  • Software Version: RFG3 : 1.11.0 or higher

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