Is the fundamental challenge in a complex 3-D structure like the knee that surgeons must cut bone to fit the patient to the implant? Does ConforMIS use data from MRIs or CT scans taken before surgery to generate a 3-D model of a patient’s knee and design an implant to conform exactly to the area in need of repair? Does the technology eliminate the need for millions of dollars worth of implant inventory for the company?
The implant, called “iUni,” is intended to resurface portions on the knee due to arthritic damage. The implants are shaped for each patient using the firm’s proprietary technology. The “iJig” cutting and placement tool is designed to limit the number of instruments needed to insert the implant, according to the company.
These approvals for both the implant and instrument enable ConforMIS to market in the European Union and provide a basis to seek expanded market clearance in Canada and Australia, the company said.
Privately held ConforMIS, which employs 42 workers, plans launch its knee implant products in EU countries including Germany, Italy, Spain and the United Kingdom in April 2008…
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