A Medical Device Daily
At this year's annual meeting of the American Academy of Orthopedic Surgeons (AAOS; Rosemont, Illinois) in San Diego —beginning yesterday and running through Sunday — the usual flow of new product announcements is in full swing, with companies both large and small hawking their latest wares to an attentive audience.
Zimmer Holdings (Warsaw, Indiana) reported that it will advance its Zimmer Gender Solutions technology with expanded research data and product solutions for gender-related issues in hip replacement at the meeting, with several presentations through Friday. It is emphasizing the evidence-based support for this line since the need for gender-specific devices in orthopedics has not been universally accepted.
During the meeting's exhibit periods, Zimmer also will feature the upcoming introduction of the Gender Solutions Natural-Knee Flex System and surgeon clinical experiences with the Zimmer Gender Solutions Knee that was released last year, it said. Data results from several new clinical studies on the Zimmer Gender Solutions Knee also will be available soon, it said.
"Our gender-focused hip research reflects the ongoing efforts at Zimmer to address very real anatomical differences with product designs and corresponding surgical techniques that help surgeons continue to improve clinical results for their patients," said Ray Elliott, Zimmer chairman, president/CEO. "We will be demonstrating to surgeons the products, technologies and design concepts we have developed to address these issues including the effects of osteoporosis. We are committed to expanding our leadership in understanding and addressing women's musculoskeletal health and are working to apply our gender-specific design philosophy wherever it is appropriate across our complete product line."
Zimmer gender-related hip research has focused on three scientific and clinical issues with identified differences between male and female hips. These are femoral head center location, femoral canal shape and femoral canal size.
"Femoral head center location" is important, the company says, because traditional implants often don't easily accommodate the shorter head heights and offsets in women, the company noted. This can increase surgical complexity, raising the risk of leg length discrepancy, impingement, and dislocation, according to Zimmer.
The Zimmer Gender Solutions M/L Taper Stem with Kinectiv Technology is designed to address the issues of offsets, head height and anteversion independently, such that an adjustment to one does not affect the others, offering the surgeon greater options in addressing specific patient anatomies.
"Canal shape" is important because in many females there tends to be greater variation between the proximal and distal width of the femoral canal. This mismatch, the company said, creates a "stove pipe" effect that forces the surgeon to use a larger diameter implant that also has more head height and more offset, a common design philosophy in many of today's implants. As a result, patients may suffer leg length discrepancies that hamper the restoration of proper joint kinematics.
According to the company, patient satisfaction research has indicated that maintaining proper leg length is especially important for women compared to men.
A new gender-specific hip stem incorporating Zimmer's Epoch composite hip technology is being developed to address femoral canal size and shape differences. Because stems utilizing Epoch technology are made from medical grade PEEK, they are more flexible than traditional implants, the company said. Zimmer said it believes the reduced bending stiffness can be helpful in situations where more "canal fill" is needed but a large metal stem could pose stress shielding risks.
A special Gender Solutions hip research area and a surgeon education presentation on gender issues in the hip is being featured in the Zimmer AAOS exhibit.
In Gender Solutions for the knee, the company recently reported that nearly 10,000 surgeries implanting the Zimmer Gender Solutions Knee were performed in 4Q06, which exceeded company expectations by more than 30%.
Zimmer launched its first-ever major direct-to-patient marketing program last fall in support of the Gender Solutions Knee.
"We are extremely pleased with how well our Gender Solutions Knee has been received by surgeons and patients since its release last year," Elliott said. "We believe this further validates our science-based approach to important gender differences, which can be addressed in total joint replacement surgery to help surgeons optimize their clinical results. Since women make up about 60% of all total knee replacement patients, the ability to expand our Gender Solutions technology to both of our two main knee product lines is an important step for us."
In other reports from the meeting:
Conmed (Utica, New York) reported that its Conmed Linvatec business unit is launching several new products at the meeting.
Among these new releases are the IM4000 TrueHD high definition camera system, the 24K irrigation system, and a new hip arthroscopy Kit. The IM4000 is designed for use in many types of endoscopic surgery including arthroscopy, laparoscopy, urology and OB/GYN.
The company said the camera system gives surgeons an increased horizontal field of view with a wider screen image to provide a much fuller visualization of the surgical site. With the greater number of pixels, the company said this system has significantly increased resolution and 3-D perception that offers surgeons greater image quality to a level previously unattainable.
The 24K irrigation system is the company's newest high-end fluid management system that provides fluid to the joint space for irrigation, distention and hemostasis during arthroscopic procedures. This system includes an inflow/outflow/suction tube set, a shaver sensor, an interarticular pressure sensor, and a remote control.
The new hip arthroscopy kit includes two 120 mm disposable operative cannulas, a 17 g hip distention needle, 40 cc syringe, guidewires, switching stick, extended length banana knife and skin marker/ruler.