Medical Device Daily Washington Editor

WASHINGTON — The orthopedic sector will see a ramp-up in announcements of new technology and other company news as the 72nd annual meeting of the American Academy of Orthopaedic Surgeons (AAOS; Rosemont, Illinois) gets under way here this week.

According to meeting planners, more than 460 companies will be exhibiting, up from around 420 at last year's meeting in San Francisco. More than 12,000 attendees are expected to descend upon the Washington Convention Center to visit company booths, attend educational programs and participate in virtual technology seminars.

Among the technology to be featured at this year's gathering, Exactech (Gainesville, Florida) reported on Tuesday the successful initial implantation of its Optecure bone graft extender for spinal fusion.

The surgery was performed by Hansen Yuan, MD, professor of orthopedic and neurological surgery and director of spine research at the State University of New York. He reported that Optecure worked well as a bone graft extender for spinal fusion, was easy to use and mixed well with autogenous bone.

Optecure is demineralized bone matrix (DBM) in a synthetic bioabsorbable polymer carrier, the first FDA-cleared medical device that includes human DBM as a component, the company said.

Earlier this month, Exactech introduced OpteMx, another biomaterial designed for spinal and general orthopedic applications. It is an engineered composite designed to chemically and structurally mimic cancellous bone, providing a conductive scaffold for bone restoration.

The company estimates that its products give it a share of an estimated market of about $200 million, representing more than 100,000 surgeries a year performed in the U.S. using DBM products. The market for all applications of synthetic biomaterials is estimated to be $75 million.

In a company statement, Bill Petty, Exactech CEO, called Optecure an “important step“ in his company's strategy to “strengthen its focus on biologic solutions to orthopaedic problems.“

Another company making news at this year's AAOS meeting is LDR Spine (Austin, Texas). The company reported receiving 510(k) clearance from the FDA for two of its fusion spine products.

LDR Spine said it would formally introduce its product line during this week's meeting.

FDA gave the nod to the company's Easyspine posterior osteosynthesis system and the BF+ complementary synthetic bone substitute, comprised of beta tri-calcium phosphate featuring outstanding biocompatibility characteristics.

LDR Spine was formed earlier this year to serve the U.S. market. A division of French company LDR Medical (Troyes, France), the company said its products have been used successfully in more than 2,200 procedures throughout Europe.

In other AAOS news:

• dj Orthopedics (San Diego), which specializes in rehabilitation and regeneration products for the non-operative orthopedic and spine markets, said it would highlight new products for orthopedic rehabilitation and bone growth stimulation at the meeting.

The company said it also would host six noted orthopedic surgeons and one noted athletic trainer at its booth, who will discuss current rehabilitation trends for the ankle, shoulder, and knee, as well as conduct product demonstrations.

There also will be a discussion on the use of bone growth stimulation devices in clinical practice.

dj Orthopedics said it would introduce its first functional brace designed specifically to help prevent ACL injuries in active females. The DonJoy Female Fource addresses biomechanical factors that have been implicated in the high incidence of anterior cruciate ligament (ACL) tears in females. The device incorporates the company's FourcePoint hinge technology, which has been clinically demonstrated to increase knee flexion angle, an important biomechanical variable for reducing ACL injury potential.

The company will introduce its new Velocity ankle brace, a low-profile, lightweight ankle brace designed to prevent abnormal ankle inversion, eversion, and rotation while allowing natural, unrestricted dorsi- and plantar-flexion. The combination of soft goods with a rigid, hinged footplate and calf cuff provides unsurpassed levels of control, fit, and support. Three Velocity versions are available.

dj Orthopedics also reported that it is launching a new soft goods accessory for its DonJoy SpinaLogic bone growth stimulator, which is designed to improve patient ease of use and comfort. The SpinaLogic device incorporates a patented bone-healing signal that only requires a 30-minute daily treatment time to improve spinal fusion outcomes, while competitive devices require hours of daily treatment time.

• PhDx Systems (Albuquerque, New Mexico), a provider of technology services for medical outcomes, reported the release of version 2 of its Hip and Knee Arthro-plasty outcomes data measurement software.

The company said Hip and Knee v2 incorporates physician requests for fewer forms, more comprehensive device data, optional radiographic data and a longer follow-up period. It also incorporates more in-depth cost-driver information, providing better assessment of the economic impact of new procedures and products.

PhDx said the Hip and Knee v2 will allow physician practices to develop their own in-house benchmarks and patient registries. It will provide healthcare organizations with comparative product and economic data and it will provide a cost-effective basis for post-market studies for device companies.

Hip and Knee v2 outcomes include an optional radiographic evaluation and tracking module that shows when X-rays should be scheduled. Practices can upgrade both the Hip and Knee v2 to include PhDx DRPro Ortho, radiographic image transmit, storage and retrieval software, which allows images to be analyzed online along with corresponding clinical data.

Orthopedic surgeons can choose from PhDx's two delivery models. The Internet-based Subscription Service, delivered through an Application Service Provider (ASP) model, gives surgeons the ability to manage their data entry, tracking and reporting through a secure web connection to the PhDx software. PhDx retains responsibility for providing and maintaining the database and IT infrastructure. This ASP model offers cost-effectiveness and simplicity of use, implementation and maintenance for single or multi-center users.

As an alternative, surgeons can elect to use the paper-based PhDx Data Service Center to outsource the collection, tracking and management of their data with reports sent monthly to the surgeon's office. PhDx offers PhDx(R) e-View to its paper users to access all of the standard patient reports.

• Zimmer Holdings (Warsaw, Indiana) said it has funded the expansion of a cross-cultural training program, created by the AAOS, which will be made available to its members and the healthcare community at the organization's meeting.

“Based on the success of our collaboration with the AAOS in 2004 with a cultural competency pilot program, we are pleased to support expansion of the program in 2005,“ said Ray Elliott, Zimmer chairman, president and CEO.

He added: “The project supports the goals of the Zimmer Minority Initiatives Program, which provides grants and coordination in the areas of minority representation in medicine and cultural competence among health care professionals.“

The goal of the AAOS program is to minimize any disparities in treatment across different patient populations that might arise from cultural misunderstandings.