Zimmer Launches Plethora of New Products at AAOS

Zimmer Holdings Inc. has always had a major presence at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting. This year was no different, though it seemed the company made an extra effort to stay in the spotlight with daily product releases and clinical trial news.

Before the San Francisco, Calif.-based event even started, the orthopedic manufacturing behemoth joined with ISTO Technologies Inc. to announce a Phase III clinical study to evaluate DeNovo ET Engineered Tissue Graft, a cartilage implant designed to repair knee cartilage damage. The graft is being developed under a collaborative relationship between Zimmer and ISTO, a St. Louis, Mo.-headquartered orthobiologics firm that develops products to regenerate and restore function to damaged cartilage and bone.

The Phase III study will comprise a randomized, controlled clinical trial involving 225 patients at up to 25 centers in the United States. The study is designed to demonstrate superiority of the DeNovo ET Graft compared with the current standard of care (microfracture) for articular cartilage defects, according to both companies.

“The DeNovo ET Graft program represents a natural extension to our early intervention and joint preservation portfolio,” said Cheryl R. Blanchard, Ph.D., senior vice president and chief scientific officer at Zimmer. “This Phase III study will generate meaningful data on the potential of this biological solution for treatment of cartilage lesions earlier in the continuum of care.”

In preclinical studies, cartilage cells derived from juvenile tissue showed a significantly greater capacity for regenerating cartilage compared to cells derived from adult cartilage. Recognizing and harnessing the significant regenerative capacity differences between adult and juvenile cells is an underlying principle of ISTO’s platform for cartilage repair. In addition, through a proprietary scalable manufacturing process, ISTO has developed a platform technology for cartilage regeneration using juvenile cartilage cells.

Zimmer’s marketing department worked overtime during the opening day of this year’s AAOS meeting, issuing several news releases about new products. One of those novel items was a patient education application for the Apple iPad called Arthritis 411. The free application—available in the Apple iTunes story—was created to help patients learn more about arthritis pain and explore treatment options, including knee and hip replacement procedures.

“Because arthritis is a medical condition for which there is presently no cure, patients spend years or even decades searching for information about treatments to manage their pain,” said Charlie Young, Zimmer’s vice president of corporate marketing. “Arthritis 411 is the first comprehensive, personalized and interactive solution for patients and their medical professionals to access constantly updated information to help navigate their treatment options.”

Company executives claim Arthritis 411 addresses two critical unmet needs:
• For patients, the application serves as an interactive, customizable way to explore various videos, images and data about joint pain and treatment options.
• For medical professionals, the program provides a point-of-care tool to help primary care physicians explain the causes of joint pain and treatment options. Surgeons can leverage simple animations and other interactive tools to help patients better understand their diagnosis and X-rays as well as surgical and rehabilitation options.

To use Arthritis 411, patients simply enter the site of their pain (knee or hip, for example), their age range and their gender to look at a comprehensive array of personalized multi-media content about arthritis and human anatomy; treatments; testimonials from other patients who have undergone similar procedures; preparation and recovery strategies; and other data about surgery or rehabilitation. The company is working to develop future versions of Arthritis 411 for smart phones and other mobile platforms.

Just in case Arthritis 411 wasn’t enough to keep journalists busy, Zimmer announced the availability of personalized surgical cutting guides for partial knee replacement procedures and introduced its Universal Power System and Stablecut line of surgical saw blades on that busy first meeting day.

Building on its platform of patient specific instruments (PSI) for the NexGen Complete Knee and the Gender Solutions Natural Knee replacement systems, Warsaw, Ind.-based Zimmer now is extending its PSI technology to partial knee replacements.

“Zimmer Patient Specific Instruments have been used to provide total knee replacement patients with a personalized surgical plan and procedure,” said Jeff McCaulley, president of Zimmer Reconstructive. “The technology is designed to ensure accurate placement of the knee implant for an optimal fit, feel and function. PSI also helps streamline the surgical procedure by eliminating numerous steps in the conventional knee replacement process, potentially reducing surgery time and increasing operating room efficiency. We are excited to now make this technology available for partial knee replacement procedures.”

Zimmer’s patient specific instruments utilize magnetic resonance imaging technology and pre-operative planning tools to create personalized guides that are tailored to each patient’s unique anatomy. Surgeons can obtain pre-operative views of a patient’s knee to construct a personalized surgical plan, including identifying the precise position and angle of numerous bone cuts.

To help with those bone cuts, Zimmer offers surgeons the Universal Power System, a device billed as a single, comprehensive large bone surgical power system, and the Stablecut portfolio of surgical blades. Obtained through last month’s acquisition Reno, Nev.-based Synvasive Technology Inc., the Stablecut product line is compatible with Zimmer’s Universal Power System.

“We have greatly strengthened our surgical resection offerings with the addition of the Universal Power System and Stablecut blades,” said Jeff Paulsen, group president, Zimmer Global Businesses. “This innovative and comprehensive surgical power equipment line effectively meets surgeon and institution requirements.”

With Zimmer’s new Universal Power System, a single hand piece can be configured for reaming, drilling and sawing with a broad range of attachments, including Stablecut surgical saw blades. The system is available with lithium battery, electric or pneumatic power supplies.

Stablecut surgical saw blades feature a ground tooth set design that allows increased debris relief, channeling bone fragments away from the cutting action, helping surgeons cut through bone faster and with more stability than conventional saw blades.

Zimmer was just as aggressive in its marketing efforts on the meeting’s second day, introducing the Chondrofix osteochondral allograft and touting the penetration of its Kinective hip implant technology, which allows surgeons to better match a patient’s anatomy with modular neck options during hip replacement procedures. The company claims the technology has been used in more than 50,000 procedures worldwide. Kinectiv is offered in conjunction with Zimmer’s M/L Taper Hip Prosthesis and more recently, with the CLS Brevius Hip Prosthesis.

The M/L Taper with Kinectiv technology is a porous, cementless stem with a broad array of neck options to match a wide range of patient anatomies. The CLS Brevius Stem with Kinectiv technology is shorter than conventional stems, providing greater bone conservation compared with other hip replacement systems, according to Zimmer.

For hips and other joints that have not yet deteriorated into disrepair, there is Zimmer’s Chondrofix osteochondral allograft, which is used to fix focal osteochondral lesions in diathrodial joints.

The technology can be used to treat cartilage lesions though the open or arthroscopic surgical procedures. It is designed to retain the mechanical properties of the pre-processed tissue, including the capacity for immediate load-bearing. The technology can be used for patients who are too young for total joint replacement or need to reduce rehabilitation time to a minimum. The allograft is minimally manipulated using a proprietary process which results in viral inactivation and terminal sterilization, giving it a two-year shelf life.

“Chondrofix technology offers an innovative new option for early intervention treatment of cartilage lesions either through an open or arthroscopic surgical procedure,” Blanchard said. “The introduction of Chondrofix osteochondral allograft expands Zimmer’s offerings across the musculoskeletal continuum of care. Chondrofix technology retains the mechanical properties of the pre-processed tissue, including the capacity for immediate load-bearing, making it ideal for patients seeking a joint preservation solution and who need to return to physical activity quickly following an injury.”