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Procedure of the Month

This is the case of a 68 year-old male suffering from severe back pain for 3 months. Patient failed conservative treatment with high doses of analgesics. MRI was performed, as shown in Figure 1 below. This T2-weighted image clearly revealed evidence of acute fracture with bone marrow edema at the L1 level. Which choice do you think best describes the patient's treatment options (click on the x-ray below to take the multiple choice/guess test)?

Figure 1: Preoperative T2-weighted sagittal MRI showed evidence of bone marrow edema indicative of acute fracture at the L1 level (arrow).

Case review and x-rays courtesy of
Dr. Bassem A Georgy.
Interventional Radiologist Valley Radiology Consultants Assistant Clinical Professor University of California, San Diego

SPONSORED BY:


Procedure of the Month Sponsored by DePuy Spine, Inc.


 

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Using DNA to Predict Scoliosis
Six million people (estimate from the National Scoliosis Foundation) have scoliosis in one form or another. The primary age for onset of idiopathic scoliosis is 10-15 years old. Finally, there is a test which can reliably predict scoliosis. Fewer X-rays. Lower cost. Better outcomes.

New Capital, New Science for Cartilage Repair
$36 million invested in the last couple of months. TiGenix has more than that in the bank to fund market penetration. Then a new paper last week finds molecular cause of OA. Cartilage repair momentum is building.

Should I Become a Physician-Employee?
Large healthcare institutions are increasingly purchasing orthopedic practices. What does this mean for patient referrals? How beneficial can it be for orthopedists? The upside is more stability, among other things…and one of the downsides is loss of freedom.

Outrageous Whistleblower Lawsuit Challenged
Spine surgeons sued by whistleblowers in Boston are fighting back. Their lawyer is outraged and says the claimants are just shopping an old and settled case to another judge. Is this the proverbial lipstick on a pig? Find out.

Medical Education Under the Microscope – Is It Up to Today’s Challenges?
Where is the line drawn between what medical schools, residencies, and professors should provide to students and what doctors-in-training should reach for themselves? Here are the results of interviews with three senior surgeons, who opine on things such as attitudes, how people learn, and the possible effects on the field.

The Underlying Meaning of Zimmer’s Purchase of Abbott Spine
From the price paid to the timing, this transaction held an underlying meaning for the entire spinal implant industry. Zimmer, the $4.2 billion (revenue) diversified orthopedic company is now #5 in spine. More to come?

Resurging Lumbar and Cervical Total Disc Replacement Markets! New PearlDiver Estimates
Rumors of the TDA market’s demise were premature. Increasingly positive long term patient data is at the core of a resurging lumbar and cervical TDR market. Senior analyst Matt Menze tackles the TDA market and interviews one of the fathers of TDR, Dr. Scott Blumenthal from the Texas Back Institute. Where is this market actually heading? We think to the $2 billion range by 2015. All details here.

Six Days in June – Biomet and Zimmer Battle for Distributors in Kentucky
Documents filed recently in a Kentucky lawsuit pull the curtain back on an epic battle between Biomet and Zimmer. For six fevered days in June 2007, Biomet CEO Jeff Binder and founder Dane Miller went into the trenches to save one of their own. For all the details, read on.

Multicenter Clinical Trials: Do They Get the Respect They Deserve?
They’re not fast or sexy, but they are critical…large trials, that is. With multiple sites and principal investigators who donate their time, large trials are more complex—and normally yield more actionable data—than smaller, quicker studies. But large trials don’t always get the respect they deserve. And, says at least one physician-researcher, this could affect the future of the field.

Patent Wars: Medtronic Attacks NuVasive
MSD’s lawsuit came amid a period of declining spinal implant market share – from a peak of 60% in late 1998 (just prior to being acquired by Medtronic) to, we estimate, 36% currently – and a growing sense that MSD’s reign as the king of spine was coming to a close. What’s really behind Medtronic’s attack on its former senior exec? Read on.

Spine Gainsharing Through the Looking Glass
The feds have issued their first opinion allowing a spine gainsharing proposal. In Alice in Wonderland style, Through-the-Looking-Glass logic, they said the proposal was improper but would not impose sanctions. Who is the author of such a plan and what’s her secret? Read here.

PearlDiver Data Raises New Questions About Synovial Injections
Synovial injections for painful knees have been approved for use since 1997. If the goal is to improve the quality of life for the patient, is that being accomplished? The latest numbers from the PearlDiver Patient Records Database cast doubt.

Plantar Fascia: The Annual 3 Million Patient Market
“Plantar Fascial Fibromatosis (ICD-9-D-728.71) is right up there in frequency with pain in the shoulder joint, degeneration of lumbar intervertebral discs, pain in the lower leg joint, and carpal tunnel syndrome. As usual, PearlDiver has this market mapped out.

Orthopedic Incubators: Where Little Ideas Grow Up
Business incubation, also known as acceleration, can be a wild ride. Thus it’s best to approach it armed with the solid advice of experienced professionals. Who should take this ride? What can venture financiers bring to the table? These questions and more are answered by two seasoned VC professionals.

Just Say No to CMS Potential Coverage Decision List
Unless you want to be on the receiving end of a non-coverage letter, just say no to CMS’ proposed list of potential National Coverage Decisions. You’ve got until September 28 to make your case. Read what a leading industry consultant and analyst have to say.

Staking a BIG Claim
Alphatec, the company whose IPO collapse served as an object lesson for all medical device companies, has nearly completed its turnaround. The key? New management and new technology. Exhibit A: OsseoFix™—with it Alphatec stakes a claim to the next big spinal implant market.

St. Francis Founder Joins Active Implants’ Board
By Walter Eisner
April 25, 2008

Active Implants Corp. (AIC), the Memphis, Tennessee, company that is developing flexible polymer products used in hip replacement surgery, has added two big-time names in orthopedics to their Board of Directors.

Henry Klyce, the founder of St. Francis Medical Technologies, and Michael Mainelli, Jr., the former President of Stryker Spine and Stryker Japan, will give AIC plenty of experience and gravitas in its board room.

The company gained approval in Europe for its first product, the TriboFit™ Hip System, in 2006. The product is a polycarbonate cup that replaces the large metal and plastic implant that is the standard upper portion of a total hip. AIC is beginning the process of commercializing the TriboFit and is preparing to raise more money to grow and expand.

It's a homecoming of sorts for Klyce, a native of Memphis, and ironically, now the home of the X-STOP®. Klyce has plenty of experience with growing companies. Along with founding St. Francis Medical, he was also its President/CEO and Chairman. St. Francis developed and marketed the X-STOP Interspinous Process Decompression System and in January 2007, sold the company to Kyphon for $725 million. Kyphon was then acquired by Medtronic, whose spine business is in Memphis.

Currently, Klyce is the founder and President/CEO of Spartek Medical, Inc., a developer of spinal implants. Prior to St. Francis, he started and built several medical device companies in ophthalmics, neurosurgery and orthopedics. Klyce has a Bachelor of Arts degree from Cornell University and is an inventor with over 30 issued patents to his credit.

Michael R. Mainelli has had several management roles in orthopedics including President, Stryker Japan and President, Stryker Spine, as well as Sector President, Medical Devices for Intermagnetics General Corporation. Mainelli also serves on the Board of Directors for Autocam Corporation. He holds an MBA from the University of Chicago, an MSE from the University of Pennsylvania and a BMSE from Northeastern University.

“As a former President of a leading orthopedic company, Michael has experience and contemporary views of the rapidly evolving global orthopedic space that can help position AIC successfully for long-term growth,” said AIC’s President and Chief Executive Officer, Stephen Bradshaw. “Henry Klyce provides a wealth of knowledge in the areas of start-up companies, early capitalization and the creation of new technology. Having the opportunity to learn from Michael and Henry at this important time will be beneficial to the future of AIC.”

 

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