Other Articles

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.

The Pennsylvania Orthopaedic Society
The Pennsylvania Orthopaedic Society, 1,000 members strong, tackles a variety of challenges on behalf of patients and surgeons alike. According to AAOS, they were the top state professional society in 2007. Fifty-two years in the making, here is how they did it.

Percutaneous Spine Procedures: Just Setting the Stage for Fusion?
Selective nerve root blocks, laminectomies, and percutaneous discectomies. How many times do these procedures lead to a full blown spine fusion? Using PearlDiver’s Patient Records Database, we longitudinally tracked patients to find out. All we can say is that after surveying the 3.9 million spine patients in the PearlDiver database, the answer may be different from what you’d expect!

Physicians Targeted by Whistleblowers
The whistleblowers that targeted Medtronic in 2006 are now aiming their guns on 136 physicians and distributors as we move into the next era of the “Great Disruption.” Read about their qui tam lawsuit in Boston and what it means for industry and surgeons.

Zimmer’s Bet on Compliance
Is Zimmer’s Enhanced Compliance Program going to cost it market share? Analysts demanded answers from CEO Dave Dvorak during the quarterly conference call on July 23 that also included the announcement of the Durom® cup suspension. Dig in here.

Faculty Compensation in Academic Medicine
Dr. Sanford Emery, Chair of Orthopaedics at West Virginia University, has put his M.B.A. to good use. Delving into the issue of compensation in academic medicine, Dr. Emery and his colleagues surveyed 31 orthopedic programs and conducted in-depth interviews with leaders of eight programs. Their findings include information on the compensation structure and point systems.

Engineering an Unfair Advantage
After $1.2 billion in equity capital, what did the tissue engineering pioneers accomplish between 1990 and 2000? For one thing, LifeCell, Integra and Osiris. For another, a generation of wiser, tougher managers who are targeting the big orthopedic markets. Now all they ask for is an unfair advantage. Are the big guys ready?

The Pain of Fashion! 4 Million Patients Every Year and Growing
Eighty-eight percent of all women wear shoes that are too small. Fifty-five percent developed bunions. Despite costs that can reach as high as $20,000 per procedure, four million patients every year seek surgical relief. Want to know the footprint of this market? Read on.

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.

Squeaky hips have gotten Stryker in trouble with the FDA, which has sent the company a series of warning letters.

We reported on the squeaky hips in December 2006 from the 23rd annual Current Concepts in Joint Replacement meeting. Three patients, called "Squeakers," were shown and heard in a video with the noisy hips. We know, it made us chuckle, too, as we imagined Uncle Charlie trying to sneak into the kitchen for a midnight snack.

However, the situation is serious enough that some patients had to go back under the knife, and now the FDA has posted a warning letter it sent to Stryker about the hips.

In fact, the agency has sent Stryker a series of warning letters regarding problems with products including the Solar Shoulder™ implant, the Trident Acetabular Cup™ and ceramic bearing, and the Duracon TS™ knee. Stryker is also investigating a separate issue with its Trident™ cups produced in County Cork, Ireland.

A copy of the warning letter was posted on the FDA site this past week. It said infractions at the company's Mahwah, New Jersey, plant encompassed failure to fix quality problems, including those related to its Trident hip replacement systems. The 11-page letter was dated November 28, 2007.

According to the letter, Stryker has been receiving complaints about components made at the New Jersey factory, including hip joints that did not fit properly, since 2005. Patients had been complaining about a range of problems, including pain, difficulty walking and “squeaky” joints, and some have had pieces of implant parts break off or wear down unevenly.

FDA officials had spent six weeks over the summer inspecting the plant, where a range of problems were found such as bacterial contamination. The contamination included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections.

This is the second time that Stryker has been warned by the FDA as a result of those inspections, and Stryker was chastised for sending the FDA inadequate responses to the initial warning between August 1 and November 1, 2007.

"Your firm has failed to implement adequate corrective and preventive actions in order to prevent recurrence of nonconforming product and other quality problems," said the letter.

More than half of the company's reconstructive products are made in New Jersey and at the facilities in Ireland. The FDA sent Stryker a separate warning about the plant in Ireland last March, citing the company's failure to remedy quality problems there.

Stryker officials responded with a written statement: "We take these matters very seriously and are committed to developing, manufacturing and marketing medical products that are safe and effective and that comply with applicable laws and regulations. We have been working diligently since July 2007 to respond to the FDA and will continue to work closely with them to address these matters."

The agency said one system was unstable, subject to shifting and loosening, and in a number of cases it failed to function. "In some instances, these problems have required revision surgeries," stated the letter.

Robert Cohen with the Newhouse News Service wrote recently about Markus Junkur, a 52-year-old construction contractor from West Chester, Pennsylvania, who said after a Stryker ceramic hip was implanted in 2006, he experienced constant squeaking and grinding sounds and a great deal of pain. He finally resorted to a follow-up surgery this past November.

Cohen reported that Joshua Jacobs, a Professor of Orthopedic Surgery at Rush University Medical Center in Chicago and member of the American Academy of Orthopaedic Surgeons, said device failures are "complex" and can result from faulty manufacture, surgical techniques, bone quality, patient medical conditions, and individual activity levels.

According to Cohen, Jacobs said "device failures are very common," adding that “the complaints against Stryker highlight the need for creation of a "national joint replacement registry" that would track device problems and provide an early warning system for doctors, patients, manufacturers, and the FDA.”

So what was the response on Wall Street?

Mike Matson of Wachovia reported that they were upgrading Stryker shares because "Stryker looks set to remain the fastest growing large-cap orthopedic firm in 2008."

That’s nothing to squeak at.