Strong demand for orthopedic implants will push the market’s growth to almost $22 billion by 2012. The 8.9% annual increase can be attributed to baby boomers, more active lifestyles, and advances in technologies, according to a study released by The Freedonia Group Inc. (Cleveland).  The industry research firm placed implants into four main categories–spinal implants, reconstructive joint replacements, trauma implants, and orthobiologics. With the availability of more advanced devices like artificial discs and fusion cages, the trend in spine is moving toward surgery as the preferred treatment versus medications or physical therapies. Spinal implants are expected to grow more than 11% each year to $6.2 billion in 2012. The strongest growth will be in fixation devices and artificial discs used in spinal fusion and motion preservation procedures, particularly surgeries that repair the vertebrae or replace degenerative discs. These areas will also account for the largest part of the market segment.Knee and hip implants will take up the most of the reconstructive joint replacement sector, which should reach $9 billion in just four years. Shoulder systems that reduce pain and restore mobility are expected to draw the most demand.Trauma fixation implants are anticipated to hit $3.2 billion in 2012. The 7.4% annual growth rate is based on the trend in rising fracture injuries from lifestyle and demographic patterns. The most progress in these implants is expected in anatomically-shaped plating systems for complex fractures near joints, along with intramedullary nails for long bone fractures. Resorbable plates and screws for craniomaxillofacial surgeries should experience strong growth as well. The demand for orthobiologics, especially considering the innovation in biotechnology and nanotechnology, is projected to reach $3.6 billion in 2012. Grafts and synthetic materials for replacing and strengthening disease or damaged bone are expected to do well. Other areas of growth include bone cement, which is used in placing reconstructive joint replacements. Viscosupplementation substances could become a strong alternative to reconstructive implants to treat knees afflicted with osteoarthritis. Bioengineered tissue implants could also become leading materials for the reconstruction of knees, elbows, and shoulders.Last year, the orthopedic implant market was dominated by Stryker, DePuy, Zimmer, Medtronic, Synthes, Biomet, and Smith & Nephew. The companies accounted for 80% of U.S. sales, according to the study. Orthopedic Implants is available on The Freedonia Group’s Web site.
The United States needs a national joint registry that tracks the condition of patients with artificial hips and knees, say experts. The collection of evidence in a registry is beneficial because the data can help save money on medical treatments that aren’t necessary and monitor potential problems with devices. An article in The New York Times cites the success of registries abroad and how they have helped intervene with device problems much faster than when companies are alerted to potential device issues in the United States. Lawrence Dorr, MD, the same doctor who recently alerted Zimmer to problems with its Durom hip cup says the United States doesn’t collect enough information about patient conditions post implantation. When he alerted implant manufacturer Sultzer Orthopedics to problems with one of its hip implants eight years ago, the company took the product off the market six months later–but nearly 3000 patients needed replacements for the implants that were contaminated with oil during the manufacturing process. However, in Sweden, a registry alerted doctors after only 30 patients had the hip implant.Â
Registries aren’t the cure-all for problems either, because they can’t spot every issue and sometimes there aren’t enough doctors who participate. There is also work involved on the part of the doctors since they have to enter data after performing procedures. Other hurdles include legal and patient privacy issues, who would be paying for a registry that could cost between $5 to $10 million each year, and whether doctor participation should be voluntary or required. Supporters of a registry also suspect that the financial relationships between orthopedic doctors and device companies could be a factor in why a registry hasn’t taken priority in the United States too.
Following complaints from doctors of a high failure rate, Zimmer has halted the sales of its artificial hip socket. However, the product has not been recalled. Doctors have been reporting that the failure of the Durom cup has resulted in patients having to undergo replacement surgery, Although Zimmer didn’t find the device to be defective, some experienced surgeons have had trouble implanting it, according to The New York Times. In April, a Los Angeles surgeon brought attention to the implant problems in a letter to his colleagues.
Zimmer expects the sales suspension to slash $20 to $30 million from its sales estimates. The company is also stopping its U.S. premarketing trials of a resurfacing system.
–From DeviceTalk
Dang Orthopedics, an orthopedics research lab, is collaborating with university researchers to create an advanced system for analyzing the effects on the spine and shoulder upon exposure to severe movements like whiplash.  Creating a computational simulation of the stress put on the cervical spine after surgery could help researchers and doctors understand the biomechanical effects of discectomy and fusion. Dang Orthopedics is working with the University of California, San Francisco, and the New England Musculoskeletal Institute at the University of Connecticut Health Center, and is using technology made by NVIDIA for its graphics. The lab made a model of cervical spine fusion using Toyota’s Total Human Model for Safety (THUMS), which was originally used to simulate the effect of car accidents on the body. Dang Orthopedics is the first orthopedic research lab in the United States to be given an academic license to use THUMS for general orthopedic research. The lab also used the simulation tool LS-DYNA to isolate the biomechanical effects of single- and two- level cervical spine fusion. LS-DYNA was initially created for nuclear weapons development and certification.Â
The resulting data from the collaborative research will aid further research involving multilevel artificial vertebral disc replacement. Understanding the procedure’s effects also has the potential to lower the incidence and severity of postsurgical complications.
Zimmer Holdings has recalled an instrument used in minimally invasive knee replacement surgeries, reports the Journal Gazette of Fort Wayne, IN. The recall decision was made after the instrument, used with the NexGen knee implant, broke during several surgeries. It is a tibial broach impactor, which helps prepare the tibial bone to accept the final implant component. The NexGen itself is not being recalled. The firm said it has notified FDA and affected customers.
St. Jude Medical has received FDA approval for a RF wireless technology that can remotely monitor an implanted cardiac device. The Merlin @home transmitter works with St. Jude’s current line of RF devices and its data management system, Merlin.net Patient Care Network, which provides remote care services for patients and their doctors. The wireless device allows patients to conduct follow-up checks on their device’s performance, and any data downloaded by the transmitter is sent to the Merlin.net system for storage and review by the patient’s doctor. The device will be launched in the United States in the fall and international in the fourth quarter.Â
A lawsuit filed against Stryker and Smith & Nephew by three patients charges that they paid more than they should have for artificial knees because the firms participated in a kickback scheme with orthopedic surgeons. The suit accuses Smith & Nephew and three divisions of Stryker of “conspiracy, unjust enrichment, fraud and a `pattern of racketeering’,” reports the Record of Hackensack, NJ. It claims that the firms’ conduct made them an oligopoly, which inflated the prices of the implants and forced patients to pay more out-of-pocket. The suit is a class-action and seeks damages and restitution for anyone who received artificial hips or knees from Stryker or Smith & Nephew.
The Access to America’s Orthopaedic Services Act of 2008 aims to improve awareness of bones, joints, and musculoskeletal health. The legislation was introduced by Congresswoman Hilda L. Solis (D-CA) and Congressman Michael C. Burgess (R-TX) yesterday. It’s also a response to gaps pointed out in the Surgeon General’s report on bone health in 2004. The bill raises concern over the potential insufficient number of doctors in the musculoskeletal field and calls for a study that reviews the amount of available funding for educating and training orthopedic physicians. Solis also said it’s necessary to improve the awareness, prevention, and treatment of musculoskeletal conditions in minority communities.
The legislation would carry out five points of action:
1. Provide Congress with reports to analyze the amount of funding for musculoskeletal research, the number of investigators entering the field, and current federal trauma care initiatives.
2. Urge the Office of Minority Health to consider musculoskeletal conditions as a health priority.
3. Advise the Agency for Healthcare Research and Quality to make recommendations for a standard and low cost technology that measures bone density.
4. Require HHS to conduct public educational campaigns.
5. Increase agency reporting requirements to improve the treatment and management of musculoskeletal diseases across age populations.
Norman Noble Inc., a medical device contract manufacturer, will undergo a major expansion of its orthopedic implant manufacturing operations. The most significant step is the addition of eight five-axis contour milling machines. They will make the firm one of the largest providers of single-operation machining to the orthopedic implant market. Most machining operations for orthopedic implants require multiple steps. The new machines will be able to perform everything in a single step. The firm will also increase capacity in its Swiss turning and milling department, and add equipment to assist in quality inspection.
The company had already begun a $1.7 million expansion of its mass finishing operation, which is also used in orthopedic implant manufacturing. It says it is taking these steps because orthopedic implants are one of the fastest-growing segments in medical device manufacturing.
The orthopedics industry is looking for a way to transmit information from knee, hip or other implants about how the implant is behaving inside the body, reports the Greater Fort Wayne (IN) Business Weekly. RFID could be the solution — and the article profiles Fort Wayne-based RFID start-up Solstice Medical LLC. Orthopedic devices must be balanced when implanted to ensure they are handling pressure properly and working correctly. Sensors imbedded in an implant could transmit that information to a receiver and computer. This kind of technology is already used in pacemakers and hearing aids.
Johnson & Johnson’s DePuy Orthopedics may have a head start on implementing something like this. In June, it received a patent for a wireless communications system. But it may be 5-7 years before a wireless-enabled orthopedic implant clears FDA.
