The FDA granted approval for the ConforMIS iTotal Hip system.
Here are five key notes:
1. The ConforMIS iTotal Hip includes the iFit technology for customized design and manufacturing of implants. The patient-specific technology creates single use 3D printed instruments and includes just-in-time delivery of the implants.
2. More than 50,000 patients have received the FDA-approved iTotal customized knee replacement implants from ConforMIS.
3. ConforMIS expects to leverage synergies with sales representatives between the iTotal Knee and Hip implants. The iTotal Hip will undergo a limited launch in 2019.
4. The iTotal Hip could reduce the risk of dislocation and leg length discrepancies. "With the ability to achieve a better match to a patient's own anatomy, the iTotal Hip system aims to address these shortcomings and improve patient outcomes," said Scott Ball, MD, of the University of California, San Diego, and member of the iTotal Hip design team.
5. ConforMIS owns or exclusively in-licenses around 450 patents and pending patent applications for patient specific instruments and implants covering all major joints.