The first artificial disc for the spine was approved by the FDA in late October, more than a decade after the device received such commercial approval in Europe. The product, made by Johnson & Johnson's (New Brunswick, New Jersey) DePuy Spine (Raynham, Massachusetts) division, is called the Charité artificial disc and is designed to treat severe low back pain by replacing a damaged or worn-out spinal disc with an artificial one. The new disc, made of two metal endplates and a plastic core, offers an alternative to the traditional surgery that fuses two bones in the lower spine. The fusion surgery often relieves pain but restricts a patient's range of motion and can strain nearby discs, requiring further surgery.
While J&J said that the Charité disc alleviates pain while helping to maintain mobility in the lower back, the FDA noted in a talk paper that the disc does not always allow movement at the implant area, and sometimes allows too much movement, which can place excess stress on the device. As part of its approval, the agency is requiring the company to further study the product's long-term safety and effectiveness. The FDA cleared the disc for patients with degenerative disc disease in the lower spine who have had no pain relief despite at least six months of non-surgical treatment.
Typically, two surgeons work together in the artificial disc operation. A general surgeon approaches the spine through an incision in the abdomen and carefully moves blood vessels and internal organs out of the way to provide access to the spine. A spine surgeon then uses special tools to remove the damaged disc and creates a space between two vertebrae for the implantation of the artificial disc. The procedure generally takes about 60 to 90 minutes and patients must have general anesthesia.
DePuy Spine acquired the rights to the Charité in June 2003 when it bought the Link Spine Group (Branford, Connecticut) for $325 million. DePuy submitted its premarket approval (PMA) application to the FDA in February and the device was granted an "expedited review" by the agency. The device was recommended for approval in June by the Orthopedic and Rehabilitation Devices panel. That panel unanimously (8-0 vote) recommended, with post-approval conditions, market approval of the device.
J&J studied the disc in 205 patients, comparing them to 99 others who had spinal fusion aided by a cage-like device that helps hold bones together. Safety information also was collected from 71 other disc recipients. The company reported that two years after the surgery, artificial disc patients fared no worse than patients who had fusion surgery, the FDA said. Complication rates were similar with both treatments. J&J said disc patients left the hospital sooner and were more satisfied with the procedure. The company also said that the clinical trials showed that Charité patients maintained or improved their range of motion, experienced pain relief sooner. There were no significant differences in complications, it said.
While artificial replacements are commonly used in hips and knees, this is the first FDA approval of such a device for spinal discs. "This is a significant breakthrough that has the potential to revolutionize spine surgery," said Scott Blumenthal, MD, principal investigator in the Charité clinical trial and president of Texas Back Institute (Plano, Texas). "Until now spine surgery relieved pain by fusing discs [and] limiting motion. Now, for the first time, we can relieve pain and preserve motion."
While J&J is the first to garner a U.S. approval for these devices, other companies are developing artificial discs for the lower back as well as the neck. These include Medtronic (Minneapolis), Raymedica (Minneapolis), Replication Medical (New Brunswick, New Jersey), Synthes-Stratec (Oberdorf, Switzerland) and Stryker (Kalamazoo, Michigan).
Motiva a TV-rich experience for chronically ill
"Must-see TV" could find itself with an expanded meaning – in the healthcare arena – based on an innovative communication program launched last month by Royal Philips Electronics (Andover, Massachusetts), Comcast (Philadelphia) and cardiovascular care provider Cardiovascular Associates of the Delaware Valley (CADV; Haddon Heights, New Jersey). Focusing on patients with congestive heart failure (CHF) – and who also are likely to have a variety of co-morbid conditions – the pilot project is evaluating the use of an interactive television platform to reduce the heavy costs traditionally associated this demographic group, and, when standard management fails, their frequent hospitalizations or deaths. Using a platform dubbed Motiva, the broader intent of this initiative is to encourage these patients to be more actively involved in maintenance of their conditions, according to Jay Mazelsky, general manager of the new ventures business unit for Philips.
Besides its interactive features, the Motiva system creates "a media-rich environment that allows an experience that the patient finds engaging and incorporates into their life," Mazelsky told The BBI Newsletter. This, he said, should translate to important modifications of behavior that produce greater compliance with drug regimens, improved tracking of changes in disease status and greater use of relevant healthcare direction and information.
Among the key components of Motiva:
Weight, blood pressure and other vital signs of the patient are sent daily to a data center so that they can be tracked by CADV clinicians, enabled by Philips home monitoring devices and a wireless set-top on the TV, and a modem supplied by Comcast. This information, especially the tracking of weight, is particularly important for this patient group, Mazelsky notes, since if CHF is not controlled it is characterized by an overload of extracellular water.
The vital signs data is then analyzed and tracked by what Mazelsky calls "a system of flags and alerts" that CADV clinicians can use to guide their contacts with the patient. They can either use the interactivity of Motiva to send messages reminding them to take their medications or to see their doctor at regular appointment times, or they can call the patient to better assess his or her overall condition, if that seems needed.
Built into the system is a strong patient education component. Here, patients can use their TV remote – featuring enlarged buttons designed for use by the elderly or those with difficulty seeing – to select from a menu of pre-programmed health topics, presented as video "modules," the topics ranging from diet to smoking cessation to diabetes care. The Motiva program so far offers about 20 such modules, with more to come, says Mazelsky.
Jeffrey Kramer, MD, fellow of the American College of Cardiology (Bethesda, Maryland) and principal investigator for CADV at the Motiva project, says the system enables what he calls "a virtual house call" on a daily basis. "It has the potential to help us optimize clinical care ... enhance the patient's quality of life while simultaneously reducing the cost of urgent clinic visits and emergency hospitalizations." And Mark Coblitz, senior vice president of strategic planning at Comcast, points to that company's network investments "to securely deliver interactive targeted and user friendly video, data and voice services" as an expanded offering to customers.
The key to Motiva's success, Mazelsky says, "is that when [patients] wake up in the morning, this becomes part of their routine and they want to make it part of their routine. You can't force compliance. You have to provide an experience and activities that engages patients and allows some level of self-management." The U.S. study is the first for the Motiva system, which he says is distinguished by being "broadband-enabled," thus offering "the capacity to send a lot more data in and out of the home." This bandwidth will provide, down the road, the opportunity to do other things," he says, including expanding the virtual house call to what he calls "virtual doctors' office visits – it provides that type of scalability."