Other Articles

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.

Biocomposites, a company headquartered in the U.K., has announced that its bone graft substitute, geneX® putty, has received FDA 510(k) clearance. geneX is a resorbable bone graft material manufactured through a proprietary process that confers the product with a reproducible negative surface charge. This property stimulates bone cell activity, accelerating bone formation by harnessing key proteins and directing osteoblast adhesion and proliferation for rapid osteogenesis.

Commenting on the FDA clearance in the news release, Biocomposites’ President Stephen Bratt said, “geneX is derived from years of peer reviewed science and extensive in-vitro and in-vivo research. By exploiting our unparalleled expertise in synthetic calcium composite technology, we have developed a new class of biomaterial, which represents a significant advance in bone grafting options for the surgeon.”

According to the company, geneX, which comes in a pre-loaded syringe, combines optimized handling and unmatched migration resistance with unique surface chemistry to trigger osteoblast differentiation for superior bone growth.

In the news release, Dr. Mark Rodger, a leading spinal surgeon based in North Carolina stated, “The negative surface charge technology of the geneX product is a very exciting development in the field of synthetic bone grafts. The clinical results I have seen to date using geneX convincingly demonstrate appositional growth of new bone. This appears around the ‘outside’ of the original material, which suggests osteoinduction due to the product’s novel surface chemistry. What is also impressive about this bone graft is that we are seeing complete resorption of the material and replacement by new bone.”

Stephen Bratt added, “geneX is the only synthetic biomaterial to show spine fusion equivalent to autograft when used as a stand alone graft material in the clinically relevant ‘Boden’ rabbit model. This response has previously only been demonstrated using BMP’s. Biocomposites has again shown its capability to offer innovative and cost effective products to the surgeon. We were the first company to bring resorbable calcium composite devices to the field of arthroscopic sports medicine and this latest first in bone grafting for spine and trauma is a reflection of the company’s focus to develop biomaterials that stimulate the appropriate cell response in-vivo.”

The company told OTW: “In the US our plans are to roll out geneX putty through our independent distributor network. In Europe, the Middle East, Africa and Asia our plans are to sell the product through independent distribution companies that are already carrying our existing bone graft products. In the UK geneX putty will be sold though our direct sales force.”

They then added, “geneX putty has been released in response to demand for new and varied forms of our already existing geneX paste. geneX paste has been extremely successful in trauma especially long bone delayed unions and non unions, and geneX putty is expected to significantly increase company sales in spinal fusion.”