Other Articles

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.

Arthroscopic Treatment for Tennis Elbow: Coming on Strong
“Tennis elbow” or lateral epicondylitis is, according to our PearlDiver database, one of the most reported diagnosis for problems with the elbow. Lately clinical evidence has shown that arthroscopic treatment for tennis elbow can provide long-term stability and, in most cases, return of the elbow to its optimal function. Check out the data from PearlDiver.

Do Republicans Make Better Orthopedic Surgeons?
A recent Nature Neuroscience journal study of the decision making differences between liberals and conservatives appears to argue in favor of Republican surgeons! Which, frankly, explains a lot—to BOTH sides and, to stretch an analogy almost to its breaking point, it may also explain why McCain’s health care plan is different from Obama’s. Read OUR take here.

"Sound of Music" Turns to Greek Tragedy for Smith & Nephew
Smith & Nephew’s Swiss (mis)adventure with Plus Orthopaedics is turning into a Greek Tragedy. The company’s whole acquisition strategy is being called into question. Read how CEO Illingworth explained it to the brutal British press.

“Dear John Letter” for Hip Resurfacing?
“Dear John H. Resurfacing: I hope this little note finds you well. We certainly have had some great times and, gosh, I’ll never forget those wonderful moments when the FDA approved your PMA. We’ve just celebrated our second anniversary together and, well, I’m just not feeling the magic anymore….” Two years after FDA approval, how happy are orthopedists with hip resurfacing? Read our analysis here.

In the Beginning, There Was the End: Manuscripts 101
Dr. Paul Manske, Professor of Orthopaedic Surgery at Washington University School of Medicine in St. Louis and Editor-in-Chief of The Journal of Hand Surgery, shares his thoughts and experience on the details of shepherding a manuscript through publication.

Did ConMed Get Re-Wired?
Ever hear about the neurosurgeon who used an $80 Bosch power drill to do brain surgery? It really happened. Surgeons like their power tools. Increasingly they also like a particular line of sterilizeable power tools from ConMed’s Linvatec unit. Did ConMed get re-wired? We have the details here.

The spine and orthopedic biosurgery experts at Orthovita, Inc. announced that they have obtained certain rights to distribute an absorbable hemostat product developed by Medafor, Inc., a Minneapolis-based medical device company. The product is approved for use as a hemostat in certain surgical procedures under a pre-market approval granted by the U.S. Food and Drug Administration in 2006 and a CE Mark granted in 2003. Orthovita plans to rebrand the product as VITASURE™ Absorbable Hemostat.

VITASURE’s hemostatic mechanism of action is based on Medafor’s exclusively licensed microporous polysaccharide hemosphere technology. Through this technology, says Orthovita, VITASURE acts as a molecular sieve to instantly extract fluids from blood, creating a powerful osmotic action that causes the particles to swell and concentrates serum proteins, platelets, and other formed elements on its surface. The VITASURE particles and their coating of compacted cells then create a matrix for the formation of a tenacious fibrin clot. The VITASURE particles are fully absorbed and enzymatically cleared within 24-48 hours.

In the news release Antony Koblish, President and CEO of Orthovita, stated, “VITASURE is an easy-to-use, cost-effective hemostat that can be used throughout the surgical procedure. Application of the product requires no mixing, reconstitution or preparation assembly. The addition of VITASURE complements our existing VITAGEL® Surgical Hemostat product, which is used primarily at the end of a surgical procedure to stop bleeding. The introduction of VITASURE to our specialized sales force will allow us to offer a complete hemostasis product portfolio to our customers. We also believe VITASURE fits exceptionally well with our sales force’s call pattern focus on spine and orthopedic surgeries and will complement the use of our VITOSS® Bone Graft Substitute product line, including our newly launched VITOSS Bioactive Foam Bone Graft Substitute product. We are pleased to have the opportunity to launch these two important new products into our specialized sales force in 2008.”

Under its distribution agreement with Medafor, Orthovita has the non-exclusive right to sell VITASURE in the spine and orthopedic fields in the United States and certain territories outside of the United States. Medafor has responsibility for manufacturing and maintaining regulatory approvals for the product. The initial term of the agreement is scheduled to expire in December 2013; Orthovita has the right to renew the agreement for an additional three-year period if certain purchase obligations are met during the fifth year of the agreement.

Commenting to OTW on physician reaction to VITASURE was Albert Pavucek, Jr., CFO of Orthovita: “As part of our due diligence process before we signed the distribution agreement, we introduced the current commercially available version of the product to several of our key spine surgeons to generate feedback and comments. In addition, each surgeon used the product in a series of live surgeries and was impressed with VITASURE's simple preparation and effectiveness as a hemostasis product. Our test group of surgeons was very positive and interested in the unique attributes of VITASURE. We look forward to fully releasing VITASURE in the U.S. market in the third quarter of 2008 with the full weight of our sales force behind it.”

He also told OTW, “VITASURE will not require much new training for our biomaterials sales force. The preparation and delivery of VITASURE is very simple. There is not assembly, mixing or blending at the time of use. The package is simply opened and the product is directly applied to the bleeding site. There are no proteins or animal-derived materials in VITASURE. VITASURE is based on plant-derived technology that effectively and simply controls bleeding. We believe this product will be an exceptionally good fit with our current sales force with minimal adjustment. We will be able to drop the product into the portfolio and go.”

Orthovita expects to launch VITASURE by the third quarter of 2008 in the United States and during 2009 in its territories outside of the United States.