ConforMIS Inc. had a double-dose of good news today for its iTotal CR custom knee implant. The company touted CE Mark approval in the European Union as well as successful completion of the first surgeries using the knee resurfacing system.
Unlike standard implants, iTotal CR devices are based on an individual’s CT scans and tailored for their knee bones using computer-aided design.
The Burlington, Mass.-based company announced that it obtained CE Mark approval for the device early in May and that the first surgeries using the iTotal system were successfully completed in Boston, Houston and Indio, Calif., last month.
The iTotal system won 510(k) clearance from the Food & Drug Administration in February.
With this clearance, all ConforMIS products including the previously launched iUni and iDuo are FDA 510(k)-cleared and CE Marked, according to the release.
The ConforMIS total knee implants, designed for patients with knee damage from conditions such as osteoarthritis, are individually built using three-dimensional CT scans of the patient’s knee. Software corrects for deformities caused by joint damage and the implants are manufactured at the company’s Massachusetts facility and shipped to the site of the surgery.
Standard implants come in six or seven different sizes, meaning that surgeons must measure a patient’s bones after an incision to select the best fit, according to ConforMIS founder and CEO Philipp Lang.
“The challenge that you have with this technique is that the implant can never fit quite right,” he told MassDevice.
The key design rationale for the iTotal system is to make the patient’s new knee feel like their own knee, Lang said, noting that the technique avoids under-sizing, which can cause early failure, and implants that are too large, which can cause soft-tissue impingement and pain. The implant, because it’s “exactly fitted” to the patient’s joint, brings back the bone’s “natural curvature” to make it feel like a normal knee.
ConforMIS also has prototypes for other joints, but is rolling out the knee technology because of its market potential, Lang said.
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