Alphatec signs new exclusive supply agreement for an anchored, zero-profile anterior cervical interbody device . . . Alphatec Spine (Carlsbad, California) has signed a new supply agreement that provides it with exclusive worldwide rights to market, sell and distribute an anchored, zero-profile anterior cervical interbody device. The device's 510(K) application is currently under review by the FDA for market clearance. Alphatec will pay an upfront fee over the next 12 months and has agreed to certain minimum purchase commitments. The market for cervical interbody devices is estimated to be $465 million. The anchored interbody device market is the fastest growing segment of the cervical interbody market and is estimated to currently be approximately $47 million. "I am pleased to announce this new supply agreement. While we compete in the cervical interbody market with certain of our Novel PEEK spacers and structural allograft products, the addition of an anchored, zero-profile cervical interbody device will add depth to our cervical portfolio with surgeons who have adopted this technology," said Les Cross, chairman/CEO of Alphatec Spine. "When I became CEO of Alphatec Spine earlier this year, I laid out a clear strategy to strengthen the sales and profitability of the organization. We have focused on streamlining our internal operations to strengthen margins and shorten the cycle time for developing and commercializing new products. I also recognized Alphatec's need to simultaneously scale our business through acquisitions of companies and new products to further accelerate top-line growth. While it has been my ongoing expectation that it will take time to yield meaningful and positive impacts to our revenue growth, we are building a new and stronger foundation that should strengthen future revenue growth and lower our cost structure through decreased manufacturing and operating costs to enhance our margins."
Depuy Synthes Spine launches new anterior cervical interbody fusion system . . . DePuy Synthes Spine (West Chester, Pennsylvania) reported the launch of the ACIS anterior cervical interbody spacer system, a comprehensive set of spacers and instrumentation for anterior cervical discectomy and fusion (ACDF).The announcement was made here at the North American Spine Society (NASS; Burr Ridge, Illinois) annual meeting in Dallas, where the company is featuring the ACIS ystem alongside the ZERO-P VA, a new zero-profile stand-alone two variable angle screw construct for ACDF that was launched earlier this year. "Each of these new systems addresses different surgical and clinical needs of patients with degenerative disc disease in the cervical spine, a major focus of innovation for us," said Namal Nawana, Worldwide president, DePuy Synthes Spine. ACIS System spacers are offered in three axial footprints (12.5 mm, 14 mm or 16 mm widths), eight heights (5 mm – 12 mm) and three sagittal profiles (lordotic, parallel or convex) to accommodate individual patient anatomy and surgical techniques. The spacers are made of Peeo Optima radiolucent material and features a large axial lumen to maximize the area for packing autogenous bone graft and enable fusion to occur through the spacer. Accompanying instrumentation streamlines the ACDF procedure. The ACIS system is intended to be used with supplemental fixation. "The ACIS System is very comprehensive and user friendly, especially with the shorter instruments, which are easier to use under the scope. The three different spacer sizes provide a good option for all patients and all levels. The larger lumen and the ability to insert large amounts of graft material is very important for adequate fusion and stability," said Ali Chahlavi, MD, a neurosurgeon at St. Vincent's Medical Center (Jacksonville, Florida).
Obese patients at greater risk of infection and other complications following knee replacement surgery . . . Obese patients have a greater risk of complications following total knee replacement surgery, including post-surgical infections, according to a new literature review recently published in the Journal of Bone and Joint Surgery (JBJS). Because of complications, obese patients are more likely to require follow-up surgery. Obesity is reaching epidemic proportions, particularly in the U.S and is a well-documented risk factor for the development of osteoarthritis. Arthritis is initially treated nonsurgically, but total joint replacement often becomes necessary if the disease progresses. Consequently, the rate of joint replacements in obese individuals has increased in the last several decades. "Orthopaedic operations can technically be more difficult in obese people, and it is important for us to know whether there is a higher complication rate in the obese, and if the long-term outcome is worse," says Gino Kerkhoffs, MD, PhD, an orthopedic surgeon at the Academic Medical Center Amsterdam, University of Amsterdam, and lead author of the study. Findings include: Obese patients have double the rate of infection following total knee replacement surgery compared to non-obese patients. Obese patients' rate of infection is higher for both superficial and deep infections. The long-term surgical revision rate for obese patients is nearly double that for non-obese patients. The paper's authors advise that knee replacement surgery not be withheld from obese patients. Rather, obese patients should be well-informed of the likelihood of complications following their total knee replacement, and advised to lose weight before surgery. Orthopedic surgeons should be prepared to refer them to medical weight-loss professionals, if necessary. The authors also note that weight loss could lessen some patients' osteoarthritis symptoms. "Although these results are not really surprising," Kerkhoffs says, "for the obese patient, this literature sheds new light on treatment options for symptomatic knee osteoarthritis: a total knee replacement is not the 'easy solution.'"
Simple intervention improves osteoporosis treatment rates . . . Older patients who visited local ERs for chest pain or breathing problems and had chest X-rays reveal unknown spinal fractures, were more apt to receive osteoporosis treatment afterward if a simple intervention was used, recently published medical research from the University of Alberta has found. Treatment rates for the bone-thinning condition substantially improved when patients and their family doctors received follow-up information about the warning signs and risk factors. It is the first and only trial in the world that looked at spinal osteoporosis. Of those patients who weren't targeted with the intervention, only 6% received follow-up treatment or testing for osteoporosis. When physicians were given educational material, the treatment or testing rate rocketed to 49%. And when both the physicians and patients were informed, the rate climbed to 65% of patients being treated or tested. Faculty of Medicine & Dentistry researcher Sumit Majumdar was the principal investigator who led the study that was published in the peer-reviewed journal The American Journal of Medicine. It looked at patients over the age of 60 who visited two Edmonton emergency departments for various complaints and needed a chest X-ray, which incidentally revealed spinal fractures. One group of patients wasn't contacted for an intervention, only physicians were contacted in another group, and both physicians and their patients were contacted in a third group. Family physicians targeted in the intervention received a one-page email, letter or fax from local doctors and nurses that explained osteoporosis treatment guidelines and recommendations. The same nurse phoned some patients to share the same information and answered patients' questions. These patients also received a pamphlet explaining the link between spinal fractures and osteoporosis. "The information we provided was not new. But the fact it was linked to a specific patient and had specific advice, it acted as a reminder about what actions family doctors could take when they next saw that patient," said Majumdar. "These fractures identified in chest X-rays are associated with a 20-fold increase of future fractures in people with osteoporosis – and these can be devastating fractures like fractures of the hip that can lead to nursing home admission or death," he says. "What was also concerning is that two-thirds of the patients in the study had a previously documented wrist or hip fracture before the X-ray was done, but they never received osteoporosis treatment." Majumdar estimates the healthcare system could save $1,000 per patient, if high-risk patients like the ones in this study received proper follow-up testing and treatment for osteoporosis. Hip fractures alone cost about $50,000 each to treat, and osteoporosis costs the Canadian healthcare system about $1 billion a year. When compared to the costs of the education intervention – $34 per physician and $42 per patient – "it's the equivalent of one month's supply of osteoporosis medication," says Majumdar. One concerning revelation he noted in the study was that 25$ of the patients were men and none of them received followed-up treatment or testing as part of usual care. Majumdar attributes this to the fallacy that "osteoporosis is considered a disease of older women." In fact, men have worse fractures and are more likely to die of hip fractures than women, said the researcher. The research was funded by Knowledge Translation Canada, the Canadian Institutes of Health Research (CIHR) and Alberta Innovates – Health Solutions. Majumdar hopes this educational intervention program could be a model for other conditions that could be identified in the ER, with follow-up care being co-ordinated by nurses or pharmacists.
— Compiled by Holland Johnson, MDD Executive Editor