Other Articles

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.

What the Knees Need: Baby Boomers and Their Options
Knee patients often show up at the doctor’s office with recurrent mechanical symptoms. It is up to the orthopedist, says Dr. Giles R. Scuderi, Director and orthopedic surgeon with the Insall, Scott & Kelly Institute in Manhattan, to thoroughly assess the patient and then determine if nonoperative treatment will do, or if the person needs a unicompartmental or total knee procedure.

Physician: Report Thyself
The government says its healthcare anti-fraud efforts are working and it wants to encourage physicians to self-report possible fraud. How well did the government do in 2007 and what about those deferred-prosecution deals with undisclosed evidence? Read about it here.

Revising the Statistics
The word that orthopedic patients least want to hear is “revision.” Who, in the universe of large joint patients, do we expect to see on the receiving end of this news? If you guessed “the elderly” you would have been wrong. The reality of who is hearing “revision” may come as a surprise. Read what we found when probing PearlDiver’s database.

Where Is Ben Now? Trends in Venture Capital
What is being funded by VCs and why? First of all, spine is having to share the spotlight, says Gary Stevenson, Managing Partner at MB Venture Partners, LLC. Here Stevenson outlines what constitutes an attractive investment…he also highlights issues that are affecting the distribution of VC funding.

The Hounds of Wall Street
Conventional wisdom on Wall Street is that ArthroCare is in a bare-knuckle fight to the finish with short sellers. Which leaves us with the dominating question: If ArthroCare is essentially a “lame duck” growth stock, then why are sales, earnings, and the stock price contradicting the short seller’s dire predictions and even outperforming consensus analyst forecasts? We have the answer.

The Era of “Tell Me Right Now” Dawns at FDA
The FDA wants the next phase of post-market oversight to change from self reporting to proactive surveillance. How? Through the Sentinel Initiative. Read what it means to device manufacturers here.

The Day After Tomorrow: Complication Rates and Instrumentation Trends in Posterior Lumbar Fusion
Could PearlDiver be the Nostradamus of spinal instrumentation? This most commonly performed surgery on the lumbar region of the spine increases fusion rates and improves spinal stability—but what about complications? Using PearlDiver’s database we find the answers. Are you ready for some quatrains about what happens next?

You Try It. No You Try It First: New Technology Adoption
What are the forces working for and against new technology adoption? Youth versus age, risk taking versus conservatism, and the economic realities of the day, says Dr. Rick Guyer, President of the Texas Back Institute.

Cheaper, Thinner, Faster, Stronger
In this, the second of our series of three articles on innovation, we tackle the question: How do you measure medical technology innovation? While difficult, measuring innovation is NOT impossible. Why? Well to start, and in the immortal words of Supreme Court Justice Potter Stewart, “We know it when we see it.”

SAS Crosses the Rubicon in Miami Beach
The SAS 8th Annual Global Symposium in Miami Beach may have crossed the Rubicon. How? Read about the Society’s opportunities for growth and collaboration as its new President lays out a vision for the future.

Some patients may be walking on pins, but that doesn’t mean they’re not walking with confidence. Small Bone Innovations, Inc. (SBi) is announcing the launch of the next-generation model of its RingFIX™ Circular Fixation System to treat diseases and trauma of the lower limb such as Charcot foot. The company is also celebrating the FDA market clearance of a series of “FootFIX” forefoot fixation pins, staples and screws to expand its lower limb portfolio.

In the news release, Anthony G. Viscogliosi, Chairman and CEO of SBi, said: “With RingFIX as the focal point of our drive toward total technology coverage in foot and ankle treatment, these next-generation, surgeon-innovated versions of clinically proven external fixation systems put SBi ahead of schedule in its goal to be the provider of choice in the small bone and joint sector.”

With expanded applications, the RingFIX System can now be used to treat a wider range of foot and ankle conditions than could its predecessor. European patients may have recognized it under the Fixano brand, a French company acquired by SBi in 2005. According to SBi, the device had an 18-year successful clinical record using the principles of the Ilizarov technique for limb preservation and correction of deformity through reconstruction and restoring function using external fixation. The current system, cleared for marketing by the FDA earlier this year, is made up of 208 components, including stainless steel half pins, rods, drill and bayonet tip wires, 53 light alloy rings, and aluminum or carbon fiber foot plate options.

Michael S. Pinzur, M.D., Professor of Adult Orthopaedics & Rehabilitation, Foot & Ankle Surgery, at Loyola University Medical Center in Chicago, said in the news release: “There is a growing body of clinical evidence that the use of sophisticated external fixation technology such as the RingFIX Circular Fixation device represents a tissue sparing and function restoring alternative to amputation for diabetic patients.”

According to SBi, the new “half pins” and aluminum footplate, which provides more “fixation points” than the prior model, responds to comments and design suggestions from several podiatric surgeons in the U.S. with expertise in circulation fixation techniques. Dr. Gary Jolly, recent past President of the American College of Foot and Ankle Surgeons (ACFAS) notes that the RingFIX™ System has been re-designed to meet the specific requirements of lower limb surgeons to make it more user friendly in the OR, compared with systems designed for a broader anatomic focus.

SBi quotes a statistic from the U.S. Centers for Disease Control that indicates more than 60% of non-traumatic lower limb amputations occur in people with diabetes—approximately 75,000 in 2003.

Mr. Viscogliosi added: “An even more distressing statistic is that 85% of amputations could be avoided through early intervention and diagnosis. Of all treatment methods offered by SBi and the industry generally, this is a huge opportunity to dramatically alter outcomes and, in essence, restore hope by saving both the form and function of the lower limb.”

SBi’s newly cleared foot and ankle management products include: StaFIX™ threaded staples; PercuFIX™ threaded pins; and TwistoFIX™ compression screws in a complete forefoot fixation set. SBi is also planning more additions to its foot and ankle portfolio following the completion of several transactions during the past year involving licenses and technology acquisitions.

The StaFIX stainless steel threaded staple set is designed for repair of small bone fractures in the foot, osteotomy, fusions and soft tissue re-attachment. The set contains three sizes of staple in a straight and angulated configuration, while the straight soft tissue staple comes in four sizes.

The PercuFIX “break-away” percutaneous titanium alloy pins are threaded (in 5 lengths, 1.8 mm dia.) and require no use of a wire cutter. The TwistoFIX self-drilling/self-tapping screw set (in 5 sizes, 2 mm dia.) with accompanying clamp enables the surgeon to determine precisely screw length and placement.

Speaking to the company’s comprehensiveness, CEO Viscogliosi added: “We are determined to offer the widest, deepest and most anatomically focused portfolio of products to cover the entire continuum of foot and ankle care and these new product launches are a major step in that direction.”