Other Articles

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.

Carpal Tunnel Syndrome: The Causal Controversy
An issue important to big business, the little guy, and insurers alike, the cause of carpal tunnel syndrome (CTS) is a hot potato. According to two orthopedic surgeons familiar with the issue, CTS is largely idiopathic. Here we examine the medical, sociological, biopsychosocial, and behavioral issues related to the problem.

Transitioning to Post-Graduate Year Two: Residents Speak
Going from PGY1 to PGY2 is like going from being robotic to being a decision maker. So say two PGY2 residents, whose experiences transitioning to their second year are telling and instructive for those designing curricula.

Chiropractic: When BS Becomes Rx
Increasingly, spine centers are incorporating chiropractic services as part of their “one-stop-shop” market positioning. This is an interesting issue for surgeons—particularly if the surgeons have a financial interest in the center. Should $30 billion BS become Rx? Maybe.

Off-Label BMP Warning Fallout
FDA’s warning last week about off-label use of rhBMP products should be fair warning to companies developing a new biologic product to be prepared to go through the regulatory ringer. What happened and what’s next? Read on.

Tissue Engineering: The View From Cincinnati
David Butler, Ph.D., a Professor of Biomedical Engineering at the University of Cincinnati, is working to shift the field of tissue engineering. He and his colleagues have set out to determine how much force a given tissue experiences and what the patterns of those forces are. The answers would then provide information for designing new products. And they’re up to much more….

Breaking the Rules to Success
On January 10, 1994, Kyphon became a corporation. That was a defining moment in corporate medical history—not because the company would sell 13 years later for $3.9 billion—but because Kyphon would eventually break almost every rule of medical technology company success. Kyphon was, we now realize, an All-American rebel and its influence is spreading to Medtronic and other companies.

U.S. Senate Fails to Stop Physician Pay Cuts; CMS Stops Processing All Claims
Congress goes on recess leaving physicians with a 10.6% pay cut from Medicare. In response, CMS halts all claims processing for two weeks. Congressional Physician’s Caucus Founder Phil Gingrey, M.D., tells us what happened and what will come next. Read here.

Biologics for Spine: Where We Are Now
Dr. Jeffrey Wang, Chief of the UCLA Spine Service and Director of the UCLA Spine Surgery Fellowship, discusses the exciting happenings in spine biologics, including growth factors, the use of different genes, and injecting stem cells into the disc. And then there are the challenges, namely the disc environment and the funding environment.

Physician Medicare Payments: Grandma vs. Docs
The fight over Medicare physician payments in Congress has been reduced to a fight over limited public dollars between Grandma and her physician. Is this a prelude to how public health care policy will be decided in the future? Read about the tussle here.

Spine Niche! Opportunity in the Spinal Deformity Market
Given the myriad of start-up companies pursuing the same patients, product differentiation and solutions for specific target markets could be the key in the future. Using the PearlDiver Patient Records Database we estimate procedure volumes for posterior fusion as a treatment for scoliosis—followed by the results of a study identifying complications associated with instrumented posterior thoracic fusion in treating scoliosis.

AAOS Political Action Committee
Active players in the orthopedic field know the importance of the AAOS Political Action Committee (PAC). On the cusp of hot topics affecting physicians and patients, the AAOS PAC works diligently to provide data to members of Congress and improve the present and future of orthopedics.

Who ARE These Guys?
Every 60 seconds or so a surgeon tears the cover off an Integra LifeSciences package. Quietly, this company has become the seventh largest medical implant manufacturer serving orthopedic surgeons in the world. Where to now? Would you believe $1 billion in two years? How about $2 billion by 2015?

Redemption in a Mechanism of Failure: The TOPS™ Story
Impliant’s TOPS™ System had a “squeaker” in its clinical study. After a voluntary suspension of the study by the company and finding the mechanism of failure, the FDA has approved a resumption of the study. What insider lessons were learned? Class starts here.

Who is Numero Uno in the PearlDiver Database!! Are You Surprised?
The answer may surprise you. Is it sore backs, aching hips, sore knees, fingers? PearlDiver details 3.8 million spine related complaints—complete with demographic information and charging information. But that’s not #1. PearlDiver also lists 3.5 million large joint complaints. Sorry, still not #1. What could the most common orthopedic complaint possibly be? To get the surprising answer…read on.

ConforMIS has announced the launch of the iUni™ unicompartmental knee resurfacing implant and its accompanying iJig™ disposable instrumentation. The iUni, to be used for osteoarthritis of the knee, is a unicompartmental resurfacing implant designed for patients whose arthritic damage is isolated to either the medial or lateral compartments of the knee, with little to no damage present in the other compartments. The implant is 510(k) cleared for marketing by the U.S. Food and Drug Administration and CE Marked for sale in Europe.

Commenting to OTW was Dr. Philipp Lang, Chief Executive Officer and Chairman of ConforMIS: “The ConforMIS patient-specific approach provides notably more bone preservation than traditional knee replacement options by resurfacing, rather than removing, healthy bone. ConforMIS is able to provide resurfacing implants by utilizing a software-enabled design process called iFit technology. The iFit process begins when a patient receives a CT or MR scan. Our proprietary algorithms convert the imaging data into a 3D representation of the patient’s knee. With this representation, we can map the patient’s articular surface, define the area of disease, and create an implant design that is precisely matched to the patient’s anatomy. Because the implants are customized for each patient, we can design each implant to conform to the patient’s joint topography (the contours of the subchondral bone), thereby avoiding the bone cutting and resection required by traditional knee replacement. Only the damaged cartilage needs to be removed. Essentially, the implants are designed to fit the patient, rather than the surgeon having to fit the patient to the implant via extensive remodeling of the joint.
Ultimately, minimizing the amount of bone loss for the patient through this resurfacing technique preserves their [the patient’s] ability to move to other surgical treatment options in the future. This is particularly important for younger or more active patients.”

In the news release, Dr. Wolfgang Fitz of Brigham and Women’s Hospital in Boston, a member of the faculty at Harvard Medical School and part of the surgeon design team for the iUni, noted, “Being able to utilize imaging data to develop patient-specific knee implants provides a significant advantage over existing traditional knee replacement techniques. The ability to take advantage of this technology for new and unique implant designs and improved surgical techniques should expand both the patients and surgeons who can successfully utilize a partial knee resurfacing product.”

The iUni comes with disposable 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.

Commenting to OTW regarding the iUni development process, Dr. Lang stated, “The original concept for the iUni evolved from discussions between me and the head of R&D (Daniel Steines) and our surgeon design team (Dr. Thomas Thornhill, Dr. Wolfgang Fitz, and Dr. Tom Minas). It began with several ideas for how our patient-specific technology could provide a bone-preserving and simplified solution to the problem of osteoarthritis in patients with disease limited to specific regions. Building on the foundation of learning in previous unicompartmental knee replacements, the team developed various prototypes which were tested for ease of surgical technique and implant function in numerous cadaver labs. Ultimately, the team settled on an optimal combination of a bone-preserving, resurfacing femur matched to an individual patient’s anatomic shape and size, and a tibial implant that provides the unique advantage of having complete cortical rim coverage for every patient.”

Dr. Lang then elaborated, “We have built in the decision rules and design principles used in developing the iUni implants into our proprietary iFit technology. The technology now allows us to efficiently extract patient-specific data from imaging studies and use that data in our design process. During the process of developing the iUni implants, the design team also began exploiting the potential of patient-specific data to develop disposable cutting and placement guides that we call iJig instrumentation. With a multidisciplinary background that combines an understanding of imaging technology, orthopedic surgery, and software development, the team was able to match the implants with instrumentation that allowed for far fewer steps, much less instrumentation, and an easier technique than traditional orthopedic surgery. The goal was to create instrumentation that allowed for more accurate placement and increased reproducibility. The team found that the best ways to do that using the patient-specific data also simplified the steps and necessary instruments.”

Dr. Lang also credits a newcomer to the company for taking up the release of the new products. “More recently, John Slamin joined us as the VP of Knee Implant Engineering. Mr. Slamin spent more than 30 years in Research & Development at DePuy and was responsible for the development activities that led to the P.F.C.® Total Knee System in 1986 and the Sigma™ Total Knee System in 1996. He is also the recipient of the Johnson Medal for outstanding Research and Development achievements. Working with original design concepts, John is now leading the team that has developed the broad commercial release version of our implant and instrumentation that we will be launching at AAOS.”

As for surgeon reaction, Dr. Lang notes, “The surgeon response to the iUni, and actually the full line approach we are taking to the treatment of knee osteoarthritis, has been incredibly positive. We are offering them an implant with truly anatomic shape and fit, unique load-bearing advantages on the tibial side, and a true resurfacing approach on the femoral side. For younger patients, there are few options that can really offer a true long-term solution to pain and debilitation while also offering the bone preservation and ability to revise to a standard, primary total [knee replacement] later on in life that our resurfacing implants can offer.”

He continued, “The real surprise for many who explore our technology or perform an iUni [implant procedure], however, has been just how easy and reproducible the surgical technique is. Our instrumentation offers the ability to digitally capture things like axis alignment, fit, and orientation pre-surgery so that the image guidance is built-in to the instrumentation. We offer these advantages without having to invest in expensive robots or computer navigation systems that add time to the procedure and costs to the hospital. In fact, since our instruments are disposable and come in a single case, there are real efficiencies in instrument handling, transport, reprocessing, and storage—which can affect OR turnover and hospital costs.”