Other Articles
 Oxiplex® – “Not Approvable”
The FDA’s Orthopaedic and Rehabilitation Devices Advisory Panel said FzioMed’s Oxiplex gel was safe but not proven to be effective, and therefore, not approvable. Did statistics get in the way of something that’s needed, works for some and is safe? Decide for yourself.
Tiger’s Knee and the Cruel Twist to the Sport of Golf
At the U.S. Open in June, Tiger Woods played through intense knee pain to stay on the leader board. His next appointment is with an orthopedic surgeon. Last year there were 103,000 golfing related orthopedic injuries reported. That’s $2.4 billion in medical care. For more on this important and growing market segment read on.
Carpal Tunnel Syndrome: The Causal Controversy
An issue important to big business, the little guy, and insurers alike, the cause of carpal tunnel syndrome (CTS) is a hot potato. According to two orthopedic surgeons familiar with the issue, CTS is largely idiopathic. Here we examine the medical, sociological, biopsychosocial, and behavioral issues related to the problem.
Transitioning to Post-Graduate Year Two: Residents Speak
Going from PGY1 to PGY2 is like going from being robotic to being a decision maker. So say two PGY2 residents, whose experiences transitioning to their second year are telling and instructive for those designing curricula.
Chiropractic: When BS Becomes Rx
Increasingly, spine centers are incorporating chiropractic services as part of their “one-stop-shop” market positioning. This is an interesting issue for surgeons—particularly if the surgeons have a financial interest in the center. Should $30 billion BS become Rx? Maybe.
Off-Label BMP Warning Fallout
FDA’s warning last week about off-label use of rhBMP products should be fair warning to companies developing a new biologic product to be prepared to go through the regulatory ringer. What happened and what’s next? Read on.
Tissue Engineering: The View From Cincinnati
David Butler, Ph.D., a Professor of Biomedical Engineering at the University of Cincinnati, is working to shift the field of tissue engineering. He and his colleagues have set out to determine how much force a given tissue experiences and what the patterns of those forces are. The answers would then provide information for designing new products. And they’re up to much more….
Breaking the Rules to Success
On January 10, 1994, Kyphon became a corporation. That was a defining moment in corporate medical history—not because the company would sell 13 years later for $3.9 billion—but because Kyphon would eventually break almost every rule of medical technology company success. Kyphon was, we now realize, an All-American rebel and its influence is spreading to Medtronic and other companies.
U.S. Senate Fails to Stop Physician Pay Cuts; CMS Stops Processing All Claims
Congress goes on recess leaving physicians with a 10.6% pay cut from Medicare. In response, CMS halts all claims processing for two weeks. Congressional Physician’s Caucus Founder Phil Gingrey, M.D., tells us what happened and what will come next. Read here.
Biologics for Spine: Where We Are Now
Dr. Jeffrey Wang, Chief of the UCLA Spine Service and Director of the UCLA Spine Surgery Fellowship, discusses the exciting happenings in spine biologics, including growth factors, the use of different genes, and injecting stem cells into the disc. And then there are the challenges, namely the disc environment and the funding environment.
Physician Medicare Payments: Grandma vs. Docs
The fight over Medicare physician payments in Congress has been reduced to a fight over limited public dollars between Grandma and her physician. Is this a prelude to how public health care policy will be decided in the future? Read about the tussle here.
Spine Niche! Opportunity in the Spinal Deformity Market
Given the myriad of start-up companies pursuing the same patients, product differentiation and solutions for specific target markets could be the key in the future. Using the PearlDiver Patient Records Database we estimate procedure volumes for posterior fusion as a treatment for scoliosis—followed by the results of a study identifying complications associated with instrumented posterior thoracic fusion in treating scoliosis.
AAOS Political Action Committee
Active players in the orthopedic field know the importance of the AAOS Political Action Committee (PAC). On the cusp of hot topics affecting physicians and patients, the AAOS PAC works diligently to provide data to members of Congress and improve the present and future of orthopedics.
Who ARE These Guys?
Every 60 seconds or so a surgeon tears the cover off an Integra LifeSciences package. Quietly, this company has become the seventh largest medical implant manufacturer serving orthopedic surgeons in the world. Where to now? Would you believe $1 billion in two years? How about $2 billion by 2015?
Redemption in a Mechanism of Failure: The TOPS™ Story
Impliant’s TOPS™ System had a “squeaker” in its clinical study. After a voluntary suspension of the study by the company and finding the mechanism of failure, the FDA has approved a resumption of the study. What insider lessons were learned? Class starts here.
Who is Numero Uno in the PearlDiver Database!! Are You Surprised?
The answer may surprise you. Is it sore backs, aching hips, sore knees, fingers? PearlDiver details 3.8 million spine related complaints—complete with demographic information and charging information. But that’s not #1. PearlDiver also lists 3.5 million large joint complaints. Sorry, still not #1. What could the most common orthopedic complaint possibly be? To get the surprising answer…read on.
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