OrthAlign, Inc. Announces US FDA Clearance for ORTHALIGN PLUS®, the most complete handheld navigation device for use in Total Hip Arthroplasty Surgery: Cup Placement, Leg Length, and Offset
Aliso Viejo, CA – June 17, 2014 – OrthAlign, Inc., a privately held medical device company, received 510(k) clearance from the United States Food and Drug Administration (FDA) to market its ORTHALIGN PLUS® system, a palm-sized, single-use navigation device for Total Hip Arthroplasty (cup placement, leg length, and offset) and Total Knee Arthroplasty (tibial and femoral) surgeries.
“The FDA’s clearance of OrthAlign Plus provides a revolutionary and cutting edge alternative in navigation technology for surgeons who are involved with Total Hip Arthroplasty surgery,” said James Young Kim, OrthAlign’s Vice President of Marketing. “Surgeons have shared with us their challenges in consistent acetabular cup positioning and confidently measuring leg length and offset. OrthAlign is now uniquely able to provide surgeons with the technology needed to firmly address those challenges and dramatically improve Total Hip Arthroplasty alignment.”
OrthAlign Plus provides measurement accuracy of ±3°, with at least 95% confidence when measuring the angle of the shell impactor, relative to the frame of reference defined by the registered landmarks. The device has been tested and validated to achieve 1) acetabular shell navigation accuracy for both inclination and anteversion, 2) measurement accuracy for changes in the femoral position in the superior-inferior direction, and 3) measurement accuracy for changes in the femoral position in the medial-lateral direction.
“The accuracy of navigation for Total Hip Arthroplasty in a simple handheld device has finally become a reality,” said David J. Mayman, M.D., Clinical Co-Director of the Computer Assisted Surgery Center, Hospital for Special Surgery, New York, NY. “Every surgeon that I speak with wants the accuracy of navigation, but doesn’t want the hassle of a big computer assisted surgery system. OrthAlign Plus makes this possible; it’s really going to change the way that we do hips.” Additionally, KNEEALIGN® technology will be fully integrated into the OrthAlign Plus system, continuing to provide a reliable and efficient alternative to expensive Computer Assisted Surgery (CAS) systems, logistically arduous patient-specific cutting blocks, and invasive conventional methods used with an intramedullary rod, for Total Knee Arthroplasty surgeries. To date, KneeAlign has successfully been used in over 17,500 Total Knee Arthroplasty cases.
In a recent study (conducted as a randomized control trial, consisting of five different surgeons) by Denis Nam, MD (Washington University, St. Louis, MO), it was found that KneeAlign decreases the incidence of outliers for tibial component alignment in both the coronal and sagittal planes, and improves the surgeon’s ability to achieve a specific, intraoperative goal, compared to conventional, tibial extramedullary (EM) alignment guides in TKA. In the KneeAlign cohort, 95.7% of tibial components were within 2° of perpendicular to the tibial mechanical axis and 95% of tibial components were within 2° of a 3° posterior slope (compared to 68.1% and 72.1% in the EM cohort, respectively).
Dr. Nam also found significant differences favoring the use of KneeAlign vs. CAS with regard to the accuracy of femoral component alignment, with 94.9% of patients in the KneeAlign cohort having an alignment within 2° of neutral vs. 92.5% in the CAS cohort. There was a significant difference in overall mechanical alignment of the limb, with 92.5% of patients within 3° of a neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort.
OrthAlign Plus will be commercially available in Fall 2014.
About OrthAlign, Inc.
OrthAlign is a privately held medical device and technology company committed to providing orthopedic surgeons with cutting edge, user-friendly, surgical navigation products for precise alignment. We believe that our technology will raise the standard of care in Total Knee and Total Hip Arthroplasty surgeries by making consistent and measurable results accessible to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precise alignment solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit www.orthalign.com.
“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN® are [registered] trademarks of OrthAlign, Inc.”
Contact: James Young Kim
OrthAlign, Inc.
Tel: 949-525-9027
jkim@orthalign.com
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