LDR Spine has received FDA clearance for a partial vertebral body replacement device, the Austin Business Journal reports. The ROI-T device has a shape that conforms to the anterior vertebral body. But it is thin and its end is tapered, so it can be implanted in a minimally invasive procedure. The company says more new product approvals should come by the end of the year.
Obese men are 70% more likely to have their hips replaced as a result of osteoarthritis than men within a normal weight range, according to a recent study. Researchers from the Lund University Hospital in Sweden also found that overweight men are more prone to having some type of joint replacement. The study is the first to show the risky relationship between being an overweight male and having hip osteoarthritis. And while it found that having a high body mass index is a risk factor for knee osteoarthritis (which leads to a total knee replacement) in both men and women, only men with a high body mass index were found to be at high risk for a total hip replacement.Â
Obese men were also five times more likely to have knee replacement surgery, and women were four times more prone to have the procedure.
The device industry and its backers have made lots of money off minimally invasive surgery in the past 20 years. It is no surprise, then, that there would be a lot of interest in the next frontier: incision-free surgery. The Pioneer Press of St. Paul, MN has a feature about the potential of surgical procedures that don’t leave even a single scar. They are known as NOTES, which stands for natural orifice transluminal endoscopic surgery. Typically, they involve using the mouth, anus, or vagina as entry points into the body. Early applications are focusing on organ-removal procedures. If NOTES takes off, the procedures would likely be performed with existing endoscopic instruments that have been modified for use with natural orifices.
The question yet to be answered is how much these procedures benefit patients. Minimally invasive surgical procedures caught on after years of skepticism because they produced similar or better results as conventional surgeries with much less trauma to the patient. It’s not yet clear whether NOTES procedures will bring that kind of substantial improvement. But if they do, a number of companies will be ready to pounce.
– From DeviceTalk.
Invibio Biomaterial Solutions, a global provider of high-performance implantable biomaterials to the surgical and medical device markets, has entered into a collaboration program with Smith & Nephew for the development of structural bioresorbable polymers.
The firms plan to develop a materials with the performance specifications needed for rigid, load bearing applications typically not achievable by resorbable biomaterial technologies currently on the market.
The development collaboration between Invibio and Smith & Nephew is an initial three year project, and is cofunded by the Technology Strategy Board’s Collaborative Research and Development program, following an open competition. The Technology Strategy Board is an executive body established by the Government of the United Kingdom to drive innovation. It promotes and invests in research, development and the exploitation of science, technology and new ideas for the benefit of business - increasing sustainable economic growth in the UK and improving quality of life. For more information visit www.innovateuk.org.
– From Biomaterials Talk.
ConforMIS Inc. has been named a winner of the 2008 Red Herring North America 100 Award. The award honors 100 companies each year that have promising technology and the potential to lead the next wave of innovation. Criteria include uniqueness of technology, experience of management team, strength of customer base, strength of business model, and financial performance.
ConforMIS developed the first personalized knee resurfacing implants. Advantages include superior fit, significant bone preservation, less trauma, and potentially faster recovery. A Q&A with ConforMIS Vice President of Knee Implant Engineering John Slamin appears in the debut issue of Med-Tech Precision.
The New England Journal of Medicine has published an editorial written by two doctors that is critical of the television ads featuring Johnson & Johnson’s Cypher drug-eluting stent. William Boden of the State University of New York at Buffalo and George Diamond of the Cedars-Sinai Medical Center in Los Angeles say the ads have not been properly evaluated and until they are, must be considered “as a `device’ of potentially deceptive advertising and as a bold, preliminary experiment in interventional psychology.” They say that the ads don’t go into enough detail about potential complications. J&J says FDA reviewed the ad prior to broadcast, and that the ads tell viewers where to find more information about risks.
Interestingly, Boden has in the past received funds from Abbott, whose Xience V could soon be a competitor to Cypher, Bloomberg reports.
Abbott says that two-year data from a head-to-head trial of its Xience V drug-eluting stent and Boston Scientific’s market-leading Taxus show that patients with Xience had significantly better clinical outcomes than patients with Taxus. Xience patients had a 45% reduction in major events such as death, heart attack, and repeat procedures, and a 32% reduction in cardiac events related to the treated vessels. Xience patients also had less stent thrombosis between one and two years after implantation than Taxus patients. FDA approval for Xience is expected to come sometime this year.
Some patients who have ceramic-on-ceramic artificial hips are finding that they squeak, and it’s becoming more than just a mere annoyance, reports the New York Times. Reports of squeaking have gone up dramatically since 2003, when ceramic-on-ceramic hips were extensively marketed in the United States for the first time. One study found that 7% of patients with ceramic hips implanted between 2003 and 2005 experienced squeaking, compared to none with hips made of metal and plastic. FDA last year gave Stryker, the U.S. market leader in ceramic-on-ceramic hips, a warning letter over failure to prevent several problems, including squeaking. Stryker says that squeaking happens to less than 1% of its patients, and is a less frequent problem than more serious ones such as infection and dislocation.
It has not been definitively determined what causes the squeaking, or if the squeaking is an indicator of more serious problems. Some think it is associated with extreme flexing, but exactly how is unclear. There does not appear to be a correlation between squeaking and misalignment, or between squeaking and increased pain.
Naturally, this won’t stop plaintiffs’ lawyers, who seem to be getting ready to bring cases claiming that squeaking is not just a minor problem. That may cause as many headaches for orthopedics companies as the squeaking itself.
Covidien announced the introduction of LigaSure Advance, which the firm says is the first multifunctional laparoscopic instrument that offers surgeons fingertip control of both tissue fusion and monopolar dissection. It is a 5 mm hand-activated instrument that provides surgeons with the ability to create fusion cycles in 2-4 sec. If used properly, it reduces the need for instrument exchanges, which could in turn reduce procedure time.
Smith & Nephew plc said an internal probe turned up “unacceptable” sales practices at Plus Orthopedics, a Swiss firm it bought last year for about $1 billion, reports Reuters. The firm did not reveal much about the problem other than that it occurred mostly in Greece. The firm said that the problem will cost it about $100 million in sales and $25 million in profits this year. That news prompted its stock price to sink 11% yesterday. Analysts were quite surprised that Smith & Nephew hadn’t turned up the problem during due diligence last year. Perhaps it got more diligent after settling with the U.S. government for $29 million late last year over kickback charges.
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