The Closure® Procedure -- A Treatment That Works

Clinical results indicate that the Closure procedure can be effective at closing the vein and significantly reducing patient symptoms.

Patient Symptoms Reported at Follow-up

Symptom	Pretreatment	8 Weeks	2 Years
Leg Pain	85%	6%	5%
Leg Fatigue	85%	12%	5%
Edema (swelling)	19%	8%	0%

 

 

Prior to the Closure procedure, 85% of patients reported leg pain. After the Closure procedure, 94% of patients at six weeks and 95% of patients at two years did not report residual leg pain.

Three randomized trials of the Closure procedure versus vein stripping, including the most recent multi-center comparative trial published August 2003 in the Journal of Vascular Surgery, show very similar results. In the most recent trial every statistically significant outcome was in favor of the Closure procedure, resulting in:

• Return to normal activities within one day for 80.5% of Closure treated patients versus 46.9% of patients who underwent vein stripping surgery
• Less post-operative pain and limitation of physical activity
• Return to work 7.7 days sooner than vein stripping patients
• Higher quality of life scores than vein stripping

Typical Cosmetic Results: Before and After the Closure Procedure

Pre-treatment	Typical results 2 weeks post-Closure

 

Percent of Legs Without Varicose Veins at Follow-up

The Closure procedure may be as effective as vein stripping in delaying the reappearance of varicose veins.

Treatment	1 Year	2 Years
Closure	90%	87%
Vein Stripping	85%	75%
Ligation	86%	57%

 

References for this report will be furnished upon request.

Safety Summary

As with any medical intervention, potential risks and complications exist with the Closure procedure. You should consult your physician to determine if your individual condition presents any special risks. Although a summary of potential complications of the Closure procedure is provided, you are encouraged to review these with your doctor at the time of the consultation.

Indication:

The Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Contraindication:

Patients with thrombus in the vein segment to be treated.

Potential Risks & Complications:

• Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthsia, skin burn.
• Treatment of veins located very close to the skin surface may result in a skin burn.
• Paresthesia may occur from the thermal damage to adjacent sensory nerves. The risk of paresthesia is higher with treatment at or below the calf.

Caution:

What Patients Are Saying About Closure®

Patients are highly satisfied with the Closure procedure.

FACT: 98% of patients who have undergone the Closure procedure are willing to recommend it to a friend or family member.

VNUS Closure is a revolutionary catheter treatment for greater and small saphenous veins. This utilizes using radio frequency energy to heat the inside of the vein to close it by internal heating destruction.This procedure involves a miniscule incision in the leg using la catheter and local anesthesia. After the procedure is completed, compression bandages and a leg wrap are applied and the patient is able to walk out of the office.

Step 1

Catheter tip positioned 2cm distal to the saphenofemoral junction. Tumescent fluid is administered.

Step 2

7cm vein segment treated all at once during 20-second treatment cycle. Additional vein segment treated serially.

Step 3

Catheter shaft allows fast and accurate catheter re-positioning between treatment cycles. No energy is delivered during the re-positioning.

Step 4

Treatment of 45cm vein takes 3-5 minutes (seven treatment segments).