Originally Published MDDI January 2005
|DePuy's Charité artificial spinal disk has generated enthusiasm in the orthopedics sector.|
DePuy Spine Inc.'s (Raynham, MA) artificial spinal disk, which received long-awaited FDA approval in October, has been touted as a revolutionary alternative to spinal fusion. It is also part of the device industry's growing trend to develop minimally invasive technologies. If this device and its soon-to-arrive competitors live up to industry expectations, it could further validate many firms' strategies around products that restore quality of life to patients quickly.
The United States is the largest market for minimally invasive devices, from imaging equipment to handheld instruments and surgical tools. DePuy's Charité artificial disk is one of many emerging technologies that result in shorter hospitalization and recovery times, lower cost, and a reduced chance of complications associated with incisions. As such, it has gen- erated much enthusiasm in the orthopedics sector.
|It will expand the spectrum of care to those who would never have considered spinal fusion. —Scott Blumenthal, MD|
"We've seen patients who were waiting for this technology to be approved and would never have otherwise entered the fusion market," says Scott Blumenthal, MD, director of the Center for Spine Arthroplasty at the Texas Back Institute (Plano, TX). "Not only will it infringe upon the fusion segment, but it will expand the spectrum of care to those who would never have considered spinal fusion."
Anthony Viscogliosi, principal at Viscogliosi Bros. LLC (New York City), an equity and merchant banking firm in the musculoskeletal and orthopedics sector, predicts that the device will garner incredible patient demand. "I think that the effect for this technology will be the greatest effect that there has ever been for a new technology in spine surgery," he says. He estimates that the market for spine arthroplasty will reach $5 billion by 2010, and that 440,000 Americans per year will have undergone the procedure by then.
The device is only for use in patients who have degenerative disk disease at the lowest segments of the lumbar spine and have experienced no relief from at least six months of nonsurgical ther- apy. Degenerative disk disease causes pain from a worn spinal disk. More than 200,000 U.S. patients undergo spinal fusion each year. This could soon change.
"The demand from surgeons and patients is extremely large," says John J. Regan, MD, codirector of the Cedars-Sinai Institute for Spinal Disorders (Los Angeles). "There's a great deal of enthusiasm about this as a revolutionary technology." A Web site survey conducted last year by Spinehealth.com even found that nearly half of spinal fusion candidates were opting to hold out for the artificial disk procedure.
"We'll see a deeper penetration each year into the spinal fusion segment of the business," says Blumenthal, a lead investigator in the clinical trial. "In this circumstance, it will be unbelievably beneficial to be the first company to market the device."
Developed in Germany in the 1980s, the disk has been used in Europe for nearly two decades. According to Blumenthal, surgeons in the United States have the advantage of clinical trial data and evidence from the device's lasting results in Europe. "It's not like this is a brand-new technology. There will be fewer false starts than if it were, say, a five-year-old device."
Despite the long-term results already seen overseas, FDA still requires a postmarket study, which involves patient follow-up for at least two more years. DePuy's parent company, Johnson & Johnson, is providing a two-day training course that surgeons must attend prior to initiating the procedure in patients.
Doctors say artificial disks offer faster recovery times and an earlier return to a regular routine than a spinal fusion procedure. "Patients have experienced better pain relief, with earlier returns to normal activity," says Regan, also a principal investigator in the clinical trial. "They leave the hospital in one to two days and return to work in two to three weeks." He says 91% have returned to work within three months.
The disk is made of a plastic center between two metallic endplates. Once implanted, it imitates the spine's natural movement and helps to decrease the deterioration of adjacent spinal levels. "This is the first device that not only relieves back pain but also preserves motion," says Blumenthal. "This is a transformational technology. It helps patients. If you have severe and incapacitating back pain, you now have an option."
Other companies in the process of developing artificial spinal disks include Medtronic Sofamor Danek Inc. (Richmond, VA); SpineCore (Summit, NJ), recently acquired by Stryker Corp. (Kalamazoo, MI); and Synthes Inc. (Oberdorf, Switzerland).
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