The Closure procedure is a minimally invasive treatment alternative for patients with a condition known as superficial venous reflux, which often results in varicose veins and other painful symptoms. Approximately 25 milion people suffer from venous reflux.

Understanding Superficial Venous Reflux and Varicose Veins

Your legs are made up of a network of veins. A healthy vein contains valves which open and close to assist the return of blood to the heart. Varicose veins are caused by damaged or diseased valves which result in backward flow of blood in your legs, a condition known as venous reflux. This can cause blood to pool in your legs and lead to symptoms such as pain, swelling and varicose veins.

The Closure Procedure

The Closure procedure, an alternative treatment option to traditional vein stripping surgery, brings state-of-the-art technology to an age old disease.

The Closure procedure is an outpatient (day surgery) treatment performed in doctor's offices, surgical centers and hospitals. Local or regional anesthesia is typically used to numb the treatment area. A thin catheter is inserted into the vein through a small opening, using only a single needle stick. The catheter delivers radiofrequency (RF) energy to the vein wall, causing it to heat, collapse and seal shut.

Once the diseased vein is closed, other healthy veins take over and empty blood from your legs. As normal return flow is re-established, your symptoms should improve noticeably.

Following the procedure, the catheter is removed, a bandage is placed over the insertion site and your leg may be wrapped typically for 1 day to aid healing. Your doctor may ask you to walk, wear compression stockings, and to refrain from long periods of standing for a period of time following the procedure to help speed your recovery. Many patients resume normal activities within 1-2 days.

Highlights of the Closure Procedure

• Relief of symptoms

• Short recovery

• Resume normal activities within 1-2 days

• Same day procedure

• Local or regional anesthesia

• Good cosmetic outcome with minimal or no scars

What Other Patients are Saying About Closure

Patients are highly satisfied with the Closure procedure.

FACT: 9 out of 10 patients who have undergone the Closure procedure would recommend it to a friend.

Connie K. - Third Grade Teacher

Nineteen years ago, Connie had her left leg surgically stripped and said, "I was in the hospital for a week, wrapped and bandaged, then off my feet for another three weeks." Connie had her right leg vein treated with the Closure procedure in January 2000. "I experienced no pain afterwards. I found that incredible in comparison with my previous experience. I had no scarring. It's incredible, absolutely incredible. I'm looking forward to wearing a skirt this summer."

Brad G. - Marketing Director

Over the last three to four years Brad experienced discomfort in his left leg, including aching, swelling, itching, hair loss and skin discolorations and sores. Brad had the Closure procedure done in December 1999. "I can say the procedure was nearly painless. I walked out of the office and went Christmas shopping the next day. Most dramatically, my lower leg stopped swelling even after a full day on my feet. Now about twelve weeks later, the skin discolorations and vein protrusions have almost vanished and the hair has grown back where before there was none. I can hardly tell that I ever had a vein problem."

The Closure Procedure - A Treatment that Works

Promising clinical results indicate that the Closure procedure can be an effective treatment alternative to traditional vein surgery, including vein stripping and ligation.

Clinical Outcomes

Evaluate at six and twelve months after treatment resulted in 86 of 91 (94%) Closure patients rating themselves as symptom free or substantially improved.

Common Questions and Answers about Closure

Q: How is the Closure procedure different from vein stripping?

A: During a stripping procedure, the surgeon makes an incision in your groin and ties off the veins after which a stripper tool is threaded through the saphenous vein and used to pull the vein out of your leg through a second incision just above your calf. In the Closure procedure, there is no need for groin surgery, instead the vein remains in place and is closed using a special (Closure) catheter inserted through a small puncture. This virtually eliminates the bruising and pain often associated with vein stripping (i.e. this may result from the tearing of side branch veins while the saphenous vein is pulled out). Vein stripping is usually performed in an operating room, under a general anesthetic, while the Closure procedure is performed on an outpatient basis typically using local or regional anesthesia.

Q: Is the procedure painful?

A: Patients report feeling little if any pain during the Closure procedure. Your physician will give you a local or regional anesthetic to numb the treatment area.

Q: How quickly after treatment can I return to normal activities?

A: Most patients can resume normal activities within 1-2 days. For a few weeks following the treatment, your doctor may recommend a regular walking regimen and suggest that you refrain from very strenuous activities (heavy lifting for example) or prolonged periods of standing.

Q: How soon after treatment will my symptoms improve?

A: Most patients report a noticeable improvement in their symptoms in 1-2 weeks following the procedure.

Q: Is there any scarring, bruising or swelling after the procedure?

A: Patients report minimal to no scarring, bruising or swelling following the Closure procedure.

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 procdure is provided, you are encouraged to review these with your doctor at the time of consultation.

Indication:

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

Contraindications:

• Patients with a pacemaker or internal defibrillator

• Patients with thrombus in the vein segment to be treated

• Patients with an aneurysmal section in the vein segment to be treated

• Patients with peripheral arterial disease as determined by the Ankle-brachial index of <.9

Possible Risks and Complications:

• Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia, skin burns, death.

• Treatment of veins located very close to the skin surface may result in a skin burn

• Paresthesia may occur from thermal damage to adjacent sensory nerves. The risk of paresthesia is higher with treatment at or below the calf.