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Good News For Aching Backs

Anulus Repair Just Got Easier

Issue: November 2008

By: Juliet Farmer

At some point during their lives, four out of five individuals will have to deal with back pain. Among the most common cause is disc herniation, which often results in chronic pain of the lumbar spine.

Previously, the standard of care was to remove the portion of the disc applying pressure to the nerves. This procedure is referred to as a discectomy and typically requires the surgeon to make an incision in the outer layer of the disc (the anulus fibrosus).

Unfortunately, there is no easy method to close the anulus following the removal of the tissue, so surgeons commonly leave the anulus to heal on its own. If scar tissue does not form over the hole, over time the remainder of the tissue inside the disc could break off and pop back out of the hole, causing a recurrent herniation.

The discectomy offers some patients relief after the procedure, but for others, the disc will eventually reherniate through the opening in the anulus, resulting in continuing pain and potentially requiring additional surgery (statistics show that approximately 30 percent of patients have pain following a lumbar discectomy and an estimated 15 percent of patients require a re-operation).

Pain and recurrence notwithstanding, there are over 800,000 lumbar discectomy procedures performed worldwide each year to treat disc herniations in the lumbar spine. Most patients take weeks, if not months, to recover completely from the invasive procedure, then watch and wait, hoping for no recurrence.

Fortunately, a new approach, called Anular Disc Repair, is not only less invasive, but also offers a long-term solution to this debilitating problem. After this procedure, patients are usually walking the same day, and commonly begin physical therapy and exercise within 10 days to two weeks.

These results are attributed to the use of the Xclose^TM Tissue Repair System, developed by Anulex Technologies, Inc. Xclose^TM is a fast, simple, and safe way to re-approximate soft tissue, and is indicated for use in procedures such as general and orthopaedic surgery. The device is used to help re-approximate tissue as a result of a defect or surgical incision, and it’s based on a concept that has been used in knee repair for over a decade.

Anulex Technologies is a Minnesota-based company that develops new technologies to repair and seal the anulus in patients who receive a discectomy. The company works closely with spine surgeons to develop new surgical technologies and refine existing ones.

Anatomy of Xclose

The Xclose Tissue Repair System itself is comprised of sterile, braided material made of polyester. When two of the bands are placed on either side of the tissue defect or incision, they can easily be drawn together to re-approximate the tissue. Essentially, the soft tissue is re-approximated with tension bands that are tensioned together. The construct is provided sterile and is preloaded on a disposable delivery instrument.

Orthopaedic specialist Dr. Abid Qureshi, chairman of orthopaedics at John Muir Medical Center in Walnut Creek, has been using the Xclose Tissue Repair System for about seven months now.

“In the past, we used a free hand technique, which could add half an hour to 40 minutes to each case,” he explains. “Using Xclose only takes about five more minutes. It’s fast, easy to use and repairs reliably.”

Dr. Qureshi earned his medical degree from the Aga Khan University Medical College in Karachi, Pakistan in 1991, and completed a research fellowship in orthopaedic oncology and molecular biology at Rush Presbyterian St. Luke’s Medical Center from 1999 to 2000, which prepared him for a dual-clinical fellowship. He gained fellowship training in orthopaedic trauma and reconstructive surgery at the Florida Orthopaedic Institute in Tampa from 2000 to 2001, and in spinal surgery at Emory University Hospital in Atlanta from 2001 to 2002.
Dr. Qureshi began practicing orthopaedic surgery in 2002. He currently practices both spinal surgery and orthopaedic trauma surgery at the Muir Orthopaedic Specialists Spine Department, and he has won several research citations including the Howard Schneider Research Award.

In addition to ease of use and speed, Dr. Qureshi says that the minimally invasive nature of the Xclose system is especially appealing.

“In discectomy, you want to do as little as possible--take as little disc as possible and preserve the disc,” he explains. “If you take too much it can accelerate the degeneration process. So it’s a good thing not to disturb the patient’s anatomy very much. With a minimal discectomy, there’s less risk of herniation, and the patient can return to activities earlier. Where before, 15% of patients would develop recurrent disc herniations after discectomy, the Xclose system significantly cuts down the risk of recurrence of disc herniation.”

The procedure is outpatient and can be performed endoscopically or microscopically. According to Dr. Qureshi, any person with a herniated disc is a good candidate for the Xclose System. “If there’s no anulus or a large anulus defect, they’re not a candidate, but as long as you have anulus to repair, you can repair it,” he notes.

Dr. Qureshi says that of the 20 cases in which he’s used Xclose, the vast majority have been younger patients with active lifestyles. “In the past, I would tell the patient to return to activity slowly, with eight weeks to three months for full recovery. Now, they can return to more activity earlier,” he adds.

The Xclose Tissue Repair System received FDA 510(k) Clearance in September 2006, with an indication for use in soft tissue approximation for procedures such as general and orthopaedic surgery. To date, there have been over 2,700 Xclose procedures performed in the U.S.

Because the product is new to market, Dr. Qureshi says, “I would like to see more data. But so far, results have been good.”

Bay Area neurosurgeons Drs. Marshal Rosario and Russell Andrews also rely on the Xclose Tissue Repair System to treat patients with herniated discs.

“In the past, there was no good way to repair the hole in the anulus,” says Dr. Rosario, who is currently in private practice in San Jose and is also Chairman of Neurosciences at Good Samaritan Hospital.. “Even a small hole had a recurrent rate of herniation. If the hole was large, we would scrape out the disc. Xclose allows us to repair the hole and cut down the risk of recurrence, with less chronic changes in the future.”

“The biggest single risk following lumbar disc surgery is recurrent herniation,” agrees Dr. Andrews, who is in private practice and works with Community Hospital of Los Gatos, Good Samaritan Hospital and O’Connor Hospital. “Xclose minimizes that risk.”

Dr. Rosario says the Xclose changes discectomy procedures minimally, and post-op, patients suffer less pain from not having to scrape out the disc. “Basically, we work in a small channel, and slide Xclose down the channel to make the repair, where the possibility to do this was not there before,” he explains of the procedure.

“I do microdiscectomies all the time, and it’s no problem adding this procedure,” Dr. Andrews concurs.

Dr. Andrews graduated from Dartmouth Medical School, and then served a surgical internship at Walter Reed Army Medical Center and a neurosurgery residency at Stanford University. Dr. Andrews has also been a neurosurgery faculty member at University of California, Davis, Medical Center; Stanford University Medical Center; State University of New York Upstate Medical Center; and Texas Tech University Medical Center.

Dr. Rosario attended the University of Hawaii, John A. Burns School of Medicine, where he graduated in 1975. He served an internship in straight surgery-categorical at Stanford University Hospital, then a trauma fellow and cardiovascular research fellow at Queen’s Medical Center and Cardiovascular Research Laboratory in Hawaii from 1976 to 1977. His general surgery-RII residency was with the University of Hawaii Integrated Surgical Residency Program in 1977 to 1978, and his neurosurgery residency was with Stanford University in 1978.

While both doctors say most patients aren’t yet aware of Xclose as a surgery option, through patient education, they expect to see more requests for it in the future.

“Recently, I had a patient who would not have surgery unless he knew I could repair his anulus,” concludes Dr. Rosario. “It’s really a simple procedure that benefits patients.”

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