A Clinical Solution

What to Expect

Minimally Invasive

The ClosureFast™ procedure eliminates the need for groin surgery and general anesthesia, and is generally performed using local anesthesia in a vein specialist’s office or an outpatient surgical facility. The procedure takes approximately 45-60 minutes and most patients typically spend two to three hours at the medical facility due to normal pre- and post-treatment procedures.

Clinical Outcomes – Recovery Study

Studies show that the ClosureFast™ procedure is associated with lower rates of pain, bruising and complications and a faster improvement in patients’ quality of life when compared to 980 nm laser ablation.¹  The average patient typically resumes normal activities within a few days following treatment, and most patients report a noticeable improvement in their symptoms within 1-2 weeks after the ClosureFast™ procedure.²∗

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ClosureFast™ Long-term Study with 5-year Follow-up

Demonstrated Long-term Effectiveness

In a large, multi-center, prospective trial, the ClosureFast™ procedure, delivered by the ClosureFast™ catheter, demonstrated the following results at 5 years.3,4

  • 91.9% occlusion rate
  • 94.9% reflux-free rate

ClosureFast Demonstrated Results

 Demonstrated Long-term Effectiveness

In over 200 patients across 8 centers, the ClosureFast™ procedure demonstrated the following high and long-lasting success rates:4

  • CEAP (classification system): 74.1% showed an improvement
  • Venous Clinical Severity Score (VCSS): Reduction in mean score from 3.9 to 0.9 (p < 0.05)
  • Pain: Increase in percentage of patients free of pain from 41.1% to 98%

† Print

Minimally Invasive

Consistent and Controlled

The ClosureFast™ catheter’s segmental approach eliminates the need for continuous pull-back of the energy source, allowing for controlled and repeatable radiofrequency ablation.

Optimal Therapeutic Power

Radiofrequency ablation delivers a lower heat gradient of energy at around 120°C. In contrast, some laser treatments can reach temperatures of over 700°C during the procedure.

CLF Illustrations Mech of Action

Improved Patient Comfort

In a head-to-head post-procedure study, patients who received the ClosureFast™ procedure experienced less pain, less bruising and a faster recovery period than patients treated with 980 nm and 1470 nm laser ablation.1

Unlike vein stripping surgery or laser ablation, the catheter delivers heat in 20 second bursts to each vein segment.  The ClosureFast™ procedure is commonly performed in an office or an outpatient setting, has been used to treat over 900,000 patients in 100 countries, and is covered by most health insurance plans in the United States and in several countries in Europe.

Therapy Comparison – Why Compromise?

Radiofrequency Ablation vs. Laser Ablation

In recent years, treatment options for CVI have advanced far beyond invasive procedures like vein stripping and ligation. Minimally invasive and highly effective endovenous ablation procedures are now the go-to for many physicians.

Easily performed in an office or hospital setting, radiofrequency (RF) ablation is a clinically proven treatment option. Radiofrequency energy is delivered at 120°C, in contrast to the more than 700°C of some laser technologies. Animal studies have shown that laser can potentially lead to vessel perforation and obliteration of the vein walls.4 Unlike RF, the primary method of action for laser ablation is to boil the blood or water inside the vessel, which can lead to both bruising and post-procedure pain for the patient.5

As with all medical procedures, there is a chance that complications may occur, including, but not limited to the following:

  • Hematoma
  • Vessel perforation
  • Thrombosis
  • Pulmonary embolism
  • Phlebitis
  • Infection
  • Adjacent nerve injury
  • Skin burn or discoloration

 

References:

1. Almeida JI, Kaufman J, Göckeritz O, et al. Radiofrequency endovenous ClosureFast versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY Study). J Vasc Interv Radiol. 2009;20:752-759.

2. L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings and B. Eklof, Randomized Clinical Trial Comparing Endovenous Laser Ablation, Radiofrequency Ablation, Foam Sclerotherapy and Surgical Stripping for Great Saphenous Varicose Veins. British Journal of Surgery Society Ltd., Wiley Online Library, www.bjs.co.uk, March 15, 2011.

3. Proebstle T. ClosureFast Long-Term European Multi-Center Study in Patients with Chronic Venous Insufficiency. American College of Phlebology 26th Annual Congress, 2012.

4. Proebstle T, Alm J, Gockeritz O, et al. Three year European follow-up endovenous radiofrequency thermal ablation of the great saphenous vein with or without treatment of calf varicosities. J Vasc Surg. 2011;54(1)146-52.

5. Weiss RA, et al. Comparison of Endovenous Radiofrequency Versus 810nm Diode Laser Occlusion of Large Veins in an Animal Model. Dermotol Surgery 2002; 28: 56-61.

* The ClosureFast™ Procedure is performed when medically necessary as diagnosed by a trained vein specialist.  It is not designed to address spider veins or cosmetic issues. However, the successful treatment of varicose veins and CVI using the ClosureFast™ Procedure can produce cosmetic improvements.  As with any medical procedure, you should consult your vein specialist and review all safety information prior to receiving treatment.

♦For 7 cm RF catheter.

†Individual results may vary. Photo courtesy of the Vein Institute of the North Shore, Beverly, MA. This picture shows results of the ClosureFastTM Procedure treatment only. Cosmetic improvements may occur sooner with adjunctive procedures. Results of ‘after’ picture is shown 3 months post procedure.