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Elegance in Spine: Extracavitary Approaches
The delicate task of dealing with spinal problems is getting a bit less complex, says Dr. Francis Shen. Orthopedists can now remove a section of rib and approach the front of the vertebrae from the back in an oblique direction.

Endotec Beats FDA, Strikes Blow for Innovation
Endotec has struck a blow for every orthopedic surgeon who wants to develop a better device. See how the company’s founders took on the FDA and got a federal judge to charge the agency with “stymieing progress and technological advancement.” How did they do it? Read on.

From Obesity to Osteoarthritis, the Carpal Tunnel Connection
It’s certainly no surprise that Carpal Tunnel Syndrome (CTS) is an exceedingly common orthopedic malady. But, as PearlDiver’s data show, the linkage between obesity, osteoarthritis and other conditions to CTS is most surprising. Check it out.

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.

It’s a jubilee for the knees…ConforMIS, Inc., manufacturer of minimally invasive medical devices for the treatment of osteoarthritis and joint damage, today announced the release of the first and only patient-specific bicompartmental knee resurfacing implant on the market. MI specialists, ConforMIS indicates that the iDuo™ is the third in the line of minimally invasive, patient-specific implants developed by the company for the treatment of osteoarthritis of the knee.

The iDuo, 510(k) cleared for marketing by the FDA, is a bicompartmental resurfacing implant designed for patients whose arthritic damage is limited to either the medial or lateral compartment of the knee, in addition to the patellofemoral compartment. ConforMIS designed the iDuo to resurface only the affected areas, and states that it preserves far more bone on both the femur and tibia than traditional knee replacement surgery. The iDuo also preserves both the anterior and posterior cruciate ligaments, helping to maintain natural knee kinematics. The extent of tissue preservation with the iDuo helps patients retain their future surgical options.

In the news release, Dr. Philipp Lang, CEO and Chairman of ConforMIS, stated, “The iDuo significantly advances the range of treatment options for patients who suffer from knee osteoarthritis. Traditionally, a patient with bicompartmental disease had total as the only option. For young and active patients, the iDuo provides a less invasive alternative that maintains their ability to move to a total knee in the future, if necessary.”

Customizations reigns here, where each iDuo is designed from an individual patient’s CT scan using the company’s proprietary iFit™ technology and made specifically for that patient. This personalization allows for individualized fit, including full coverage of the tibial cortical rim and a simplified surgical technique.

Detailing the inner workings of the product, Jong Lee, the company’s Senior Vice President of Marketing told OTW, “ConforMIS iFit™ Technology takes CT scan data and converts it into a virtual 3D representation of the patient’s knee. Our software maps the topography of the articular surface and establishes the biomechanical axis from the scan data. Based on this data, our design engineers work with the software to produce a bicompartmental femoral implant and a tibial implant designed for that unique anatomy.”

Commenting to OTW on surgeon interest in the product, Lee noted, “The iDuo has generated a lot of interest from surgeons who have focused on the uniqueness of the concept. It is one of only two bicompartmental implants available on the market, and the only one that takes advantage of patient-specific data to ensure optimal fit. The patient specific instrument set has also generated quite a lot of interest as a much more intuitive way to approach the technique for dealing with technically challenging partial knee procedures.”

In the news release, Dr. Tom Minas, Director of the Cartilage Repair Center at Brigham and Women’s Hospital in Boston and part of the surgeon design team for the iDuo, stated, “The move toward patient-specific approaches enables the possibility of a minimally invasive, bone preserving, resurfacing procedure that allow patients to avoid a traditional total knee replacement, particularly if they are young and active. As a surgeon, though, what has been especially intriguing for me is how much this approach has simplified and improved the surgical technique that can be employed for partial knee procedures.”

The company has packaged the iDuo with patient-specific instrumentation called iJigs™, which are designed from the same scans as the implant, including data on the patient’s biomechanical axis. The iJig cutting and placement guides eliminate manual sizing during surgery and provide tactile guidance to precisely place the instruments, simplifying the surgical technique. One tray of disposable iJigs replace multiple trays of traditional instrumentation that would typically have cost a hospital several hundred dollars per surgery in instrument handling, storage, sterilization, and lost operating room time.

Regarding the sales strategy, Lee told OTW, “We began a limited release of our partial knee resurfacing system, which includes the iUni™ and iDuo, to a small group of surgeons in the second half of 2007. With their help, we have really refined the instrumentation and approach to create what we think is one of the simplest and most reproducible surgical techniques available for a partial knee procedure. We introduced the iUni in March of this year with the benefit of that feedback and are now introducing the iDuo for broad release, fully incorporating all of the learnings we have gathered over the last year.”