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Procedure of the Month

This month's Procedure of the Month patient presented with chronic low back pain (3/10), with acute onset of right lower extremity pain (5/10). A physical exam showed weakness (4/5) of Rt. Extensor Halitus Longus, otherwise normal. X-ray images show Degenerative Disc Disease at L4/5. Provided below are two images of the patient’s lumbar spine.

Pre-op images - AP and Lateral View


Which choice do you think best describes the patient's treatment options (click on the x-rays above to take the multiple choice/guess test)?

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Procedure of the Month
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Orthopedics News

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Two Patients in One: Working With Pregnant Patients
By Elizabeth Hofheinz (posted December 16, 2008)
It’s an unusual day when a pregnant orthopedic patient shows up in the ER. Critical to a successful outcome is an appropriate treatment algorithm, along with being cared for in a center that has some experience with such cases.

Stem Cells What is the immutable 20-year rule and how does it apply to the commercialization path for the next great biologic technology, stem cells? Find out at the 4th Annual Stem Cell Sumit - February 17, 2009.


FDA Misbehaviors
By Robin Young (posted December 16, 2008)
In a handful of recent cases, the FDA has been downright Kafkaesque. Recently, a small supplier of medical products, Shelhigh, Inc. was brought to its knees by the FDA—but then turned the tables.  Find out more here.

"SpinalMotion conducts the first ever artificial lumbar disc-to-disc clinical trial in the U.S. But there's much more to its technology platform. Its Kineflex® technology is bringing new designs for a posterior disc, a shock absorption disc, and a laterally placed lumbar disc. Check out this company in motion."

A Look Back on 2008: A Year of Disrupted Relationships
By Walter Eisner (posted December 16, 2008)
Relationships between physicians and industry were disrupted in 2008, as the government acted to protect the patient/physician relationship. What will this “Era of Disrupted Relationships” mean for physicians, industry, and patients in 2009? Read our take here.

Don’t Dump, Delegate
By Elizabeth Hofheinz (posted December 9, 2008)
Assessing the task at hand and planning for delegation are just two things that make the delegation decision process complex. Done incorrectly, says Dr. Brian Cole, Professor at Rush University Medical Center, and delegation can be construed as “dumping.”

The Cheapest Orthopedic Company Ever
By Robin Young (posted December 9, 2008)
The market for equities has become a flea market, a thrift shop, a place where cheapskate buyers pick through piles of discarded, broken and ignored pieces of companies. Like Osteotech—the cheapest orthopedic company ever.

“Pirates” of the Caribbean Attack Orthofix
By Walter Eisner (posted December 9, 2008)
Caribbean-based Orthofix International is under threat of being boarded by hedge fund pirates who want it to toss Blackstone Medical overboard. Read about this swashbuckling drama here.

Spine Market Share Changes This Year
By Matt Menze (posted December 9, 2008)
Sales reports for the first nine months of this year confirm that, with only two key exceptions, major spine companies are losing share to smaller players. Can they reverse these trends? Or, will the big guys resort to acquisition and consolidation strategies?

Ins and Outs of Outsourcing
By Elizabeth Hofheinz (posted December 2, 2008)
When, how, and why should an OEM select an outsourcer? Kelly Lucenti, President of Millstone Medical Outsourcing, explains which activities are being outsourced and why…and how to choose an outsourcer.

Off-Label Use of InFuse® Bone Graft
By Robin Young (posted December 2, 2008)
InFuse® is used off-label—perfectly legally. Why? It works really well and the FDA screwed up the label. Now that the DOJ is subpoenaing Medtronic over off-label use of Infuse, have two federal agencies screwed up?

Mutiny on the FDA
By Walter Eisner (posted December 2, 2008)
A mutiny on the good ship FDA by scientists is prompting Congress to investigate allegations about the “corruption” of the scientific review process by agency civilians. Read about the high drama here. 

Cartilage Repair – Replacing Joint Arthroplasty?
By Scott Ellison (posted December 2, 2008)
The horse-drawn carriage was replaced by the automobile. Could cartilage repair technologies ever make knee replacement/reconstruction obsolete? New technologies make that idea not be so far-fetched.

Orthopedics in China. Wow!
By Robin Young (posted November 17, 2008)
The Chinese Orthopedic Association (COA) is setting its sights on becoming the AAOS of Asia, if not the globe.   Thirty thousand members, 7,200 papers and surging patient demand.  Who are the leaders? Who are the laggards? Check it out.

Healthcare 2009: A Crisis Is a Terrible Thing to Waste
By Walter Eisner (posted November 17, 2008)
Congress and the president-elect are promising healthcare reform for 2009. No doubt next year will be a big one for the American healthcare system. But, not everyone agrees on the prescription.

What Do the Foot and Ankle Surgeons Have to Say?
By Dev Joshi (posted November 17, 2008)
New survey of 800 foot and ankle surgeons tells PearlDiver which companies are most innovative, most responsive and have the best training programs.  Interested? PearlDiver has the data.

Kandahar Days: Orthopedics Under Fire
By Elizabeth Hofheinz (posted November 13, 2008)
“Here’s what to do if captured.” Fortunately, Dr. Michael McKee, from St. Michael’s Hospital in Toronto, didn’t have to worry about that. He just focused on helping soldiers and civilians in Afghanistan.

Rough Economy, Fewer Ortho Surgeries?
By Robin Young (posted November 11, 2008)
Does 6%, 7%, 8% or 9% unemployment mean a decline in hip, knee or spine surgery? Kristen Stewart, Catherine Hu and Li Cal of Wall Street bank Credit Suisse recently checked and concluded that this recession may well be different from past downturns and undercut demand for orthopedic procedures.

Partnering: How Companies Can Work With a Recruiter
By Elizabeth Hofheinz (posted November 10, 2008)
Cherie Friedman of Friedman Search Group sheds light on the nuances of candidate selection, offer negotiation, and why existing rep-surgeon relationships aren’t necessarily a good thing. Learn the importance of realistic expectations and how to keep candidates engaged throughout the process.

Medtronic Disputes NASS’ Kyphoplasty Letter
By Walter Eisner (posted November 10, 2008)
Medtronic disputes the letter NASS (and four other spine surgeon societies) sent to Medicare. The written language was diplomatic but the body language was not. For the record, Medtronic called NASS’s characterization of kyphoplasty “somewhat out of place.” The controversy grows.

 

   

News Shorts
Complete Issue - PDF Past Issues

Pioneer Raises $15 Million for NuBac IDE Study
Pioneer Surgical is getting a helping hand from the State of Michigan. The Upper Peninsula device company has raised $15 million in new investments to pay for an FDA pivotal study for its NuBac nucleus replacement device.

FDA Holiday Present for ReGen Biologics
Merry Christmas, Happy Hanukah and Happy New Year ReGen Biologics shareholders. We’ll also throw in a Happy Kwanzaa and Solstice for good measure. ReGen needs all the friends it can get.

Synovial Celebration: MabThera Inhibits Joint Destruction in RA
Hope flowing from the lab…MabThera. Roche is announcing today that MabThera (rituximab) has been shown to significantly inhibit structural damage to joints in patients with early rheumatoid arthritis (RA) who have not been treated with methotrexate (MTX), the current standard of care for RA treatment.

Canadians Receive $1.3 Million for Engineering
Taking a bite out of arthritis, osteoporosis, etc…Dr. Douglas Hamilton, a dental researcher with the University of Western Ontario, has received substantial funding from The Canadian Foundation for Innovation (CFI) to engineer stronger bone and cartilage tissue to treat patients with traumatic injuries or bone disease.

Congressional Healthcare Reform: Irresistible Forces and Immovable Objects
Those who believe that Congress will move quickly and dramatically during the first days of the Obama Administration on comprehensive national healthcare reform got a cold shower on December 19.

Study: Pycnogenol® Reduces Marker in OA
Another reason to make a pilgrimage to France…Horphag Research Ltd. is announcing that the third osteoarthritis (OA) study this year is showing that Pycnogenol® lowers the inflammatory marker C-reactive protein (CRP).

Daschle Will Lead Health Care Reform for Obama
Former Senate Majority Leader Tom Daschle of South Dakota will be the country's new health care czar. He’ll be health care czar who has written that “doctors and patients might resent any encroachment on their ability to choose certain treatments, even if they are expensive or ineffective compared to the alternatives.”

Medtronic’s Excellent China Spine Adventure
Medtronic's toe in China just got a little wetter. The company announced on December 18th that it had completed its equity investment in China's Weigao Group Medical Polymer Company Limited.

Baring the Medical Soul: Disclosure Summit
The first annual summit on disclosure, transparency and aggregate spend for drug, device and biotech companies will be held March 5 and 6, 2009 at the Renaissance Washington D.C. Hotel…and now they are announcing the keynote faculty, agenda and Disclosure Training Program.

Centinel Spine Continues Transformation
Centinel Spine, the descendant of Raymedica, continues to morph into its new form. On December 16, Centinel Spine announced that the company was on track to see increased revenue by early 2009 due to having secured exclusive distribution rights to market STALIF TT™ (Stand Alone Lumbar Interbody Fusion) products for the entire globe.

Orthofix Defends Itself and Dumps Debt
As Orthofix fights off a hedge fund threatening to board its corporate ship, the company announced that it was going to dump some ballast by paying off some debt early.

New AAOS Guideline for Knee OA
Before you cut…AAOS is announcing the release of an evidence-based clinical practice guideline on “Treatment of Osteoarthritis of the Knee,” a protocol that was explicitly developed to include only treatments which are less invasive than knee replacement surgery.

Nose to Bones: Tentative FDA Nod for Osteoporosis Spray
MDRNA, Inc., a company focused on products based on RNA interference (RNAi), has announced that the FDA has granted tentative approval of its Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis.

Cool Discovery: New Genetic Info on Low BMD
Icelandic researchers from deCODE genetics, along with colleagues from Australia and Denmark are reporting the discovery of common single-letter variations (SNPs) in the human genome linked to low bone mineral density (BMD).

MA Plans Bring $1.3 Billion Extra Profits to Insurers
Congress stuck another fork into the Medicare Advantage (MA) program on December 11. House Ways and Means Health Subcommittee Chair, Congressman Pete Stark of California, had requested an analysis from the Government Accountability Office (GAO) about the MA plans' profits for 2006.

Gang of Four Named To Challenge Orthofix Directors
We recently reported that hedge fund Ramius LLC was threatening to call a special meeting of Orthofix shareholders. At the meeting, if called, they would vote to throw four of ten current Orthofix board members overboard and replace them with Ramius' own slate of candidates.

Direct Hit: BioMimetic Achieves Enrollment Target
BioMimetic Therapeutics, Inc. has announced that the company has completed the enrollment of 396 patients in its North American pivotal clinical study for its lead orthopedic product candidate Augment™ Bone Graft. The study is designed to assess the safety and efficacy of Augment for the treatment of hindfoot and ankle fusions as compared to autograft.

U.S. Army Aiming for ‘Disruptive Technologies’
Who knew there was a U.S. Army Science Conference?  In the shadow of Disneyworld no less. But, sure enough, it does exist and this past week a number of cool, futuristic, and potentially “disruptive” medical technologies were on display at the U.S. Army Science Conference in Orlando, Florida.

People in the News

Dr. Andrew Lynn Garners Entrepreneurial Award

Dr. Richard D. Scott Joins ConforMIS Board

Pete Wehrly Lands at Medingo

Upcoming Conferences

5th Annual Emerging Technologies Spine Education Summit
February 4 - 7, 2009 – Steamboat Springs, Colorado

4th Annual Stem Cell Summit
February 17, 2009 – New York

   

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