Originally Published Med-Tech Precision Fall 2009
FROM THE EDITORS
A Personalized Approach to Orthopedics Design
A ceramic-on-metal implant provides orthopedic surgeons and their patients with more choices, which is just one way that the world of ortho is moving toward individualized treatment.
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FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee recently recommended FDA approval of the DePuy Orthopaedics’s Pinnacle CoMplete acetabular hip system, the first ceramic-on-metal hip bearing to be considered for approval in the United States (see the news story on p. 17). If approved, it would mark another step toward more personalized devices in the orthopedics market.
In his article on p. 24, David Chen, chief technology officer of SensAble Technologies Inc. (Woburn, MA), describes the confluence of factors that are contributing to this personalized trend.
“Patient-specific implants now are becoming more common and are readily designed. Patient-specific implants are also developing into a viable business for orthopedic firms, which can command a premium for custom implants,” he says.
Such custom implants fit better and are significantly faster and less expensive to design and manufacture than they were a few years ago. But even having more off-the-shelf options is providing a new landscape for orthopedic surgeons.
“If approved by FDA, the Pinnacle CoMplete System would represent an important innovation for hip replacement in the United States,” said Pamela Plouhar, PhD, vice president, Worldwide Clinical Affairs, for DePuy Orthopaedics. “Each new implant provides orthopedic surgeons and their patients more choices, which result in more individualized treatment based on specific patient anatomy, lifestyle, age, medical condition, and surgeon preference.”
The Pinnacle system would be used in adult patients who suffer from severe pain and disability due to osteoarthritis or posttraumatic arthritis. Conditions for approval recommended by the panel include refinements to the proposed product labeling and a postapproval study. The system is currently limited by U.S. law to investigational use only.
Another company, ConforMIS, is taking a novel approach to using technology to create personalized knee implants for patients with arthritis. The company recently raised $50 million in U.S. and international funding. The funds will in part enable ConforMIS to prepare for the launch of its iTotal system, which allows surgeons to resurface and preserve most of the tissue in the knee joint. The company will be using the $50 million to deploy and fully commercialize iTotal, including completing product development and preparing the sales force, marketing, and commercialization infrastructure that come with the product rollout.
With three successful partial knee implants on the market, ConforMIS is looking to expand to areas outside of the knee after the release of iTotal. According to CEO Philipp Lang, MD, the patient-specific options that ConforMIS offers patients puts the company in a unique position in the $20 billion orthopedics market. The future is definitely not one size fits all.
Sherrie Conroy
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