OrthAlign, Inc. Receives Prestigious Frost & Sullivan Technology Innovation Award
OrthAlign, Inc., a privately held medical device company, today announced that its precision alignment technology was awarded the 2015 Frost & Sullivan Technology Innovation Award in Orthopedic Alignment.
Each year, Frost & Sullivan has a global team of analysts continuously researching and identifying companies that are predicted to drive significant growth in their industries and revolutionize the way that things are currently done through new and innovative technologies. With its strong overall performance, OrthAlign was recognized as this year’s Technology Innovation Award recipient in Orthopedic Alignment.
OrthAlign’s alignment technology platform addresses both Total Knee (TKA) and Total Hip (THA) Arthroplasty procedures in a simple, palm-sized, single-use device and is compatible with all implant systems. More than 30,000 arthroplasty cases have been successfully completed, worldwide, using OrthAlign technology.
“Building on a powerful and sensitive navigation platform, OrthAlign’s products not only surpass conventional mechanical guides in performance, but also match the precision of CAS (Computer Assisted Surgery) devices, which are widely accepted as the industry standard,” said Bhargav Rajan, Senior Research Analyst at Frost & Sullivan. “OrthAlign deserves credit for successfully offering a single-use, handheld device without any capital investment as an alternative to the million-dollar, space-consuming CAS device. Development of these products marks an important milestone in the design and advancement of surgical navigation devices.”
In a published TKA clinical study by Denis Nam, M.D. (Washington University, St. Louis, MO), significant differences favoring the use of KneeAlign vs. CAS were found 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 also a significant difference in overall mechanical alignment of the limb, with 92.5% of patients within 3° of neutral mechanical axis in the KneeAlign cohort vs. 86.3% in the CAS cohort.
In another TKA study by Dr. Nam (conducted as a randomized controlled trial, consisting of five different surgeons), 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).
The THA application, branded as OrthAlign Plus® and commercially available in the United States and Australia this summer, 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.
“Frost & Sullivan joins leading orthopedic surgeons in commending OrthAlign’s innovative product design. The Company’s products, OrthAlign Plus and KneeAlign, elegantly package cutting-edge navigation and sensor technology platforms into palm-sized devices. The products seamlessly integrate into the surgeon’s workflow, and meet and exceed all alignment benchmarks, while offering a price point that competing technologies would find difficult to match,” said Rajan.
“OrthAlign set out on a mission to develop an innovative technology that improves surgical accuracy and precision in a field where expensive, time-consuming, and intrusive technologies failed to make inroads and be relevant,” said David Mayman, M.D. (Hospital for Special Surgery, New York, NY). “Frost & Sullivan’s recognition of OrthAlign, combined with proven clinical studies, increasing surgeon adoption, and my very own experience, reaffirm my enthusiasm and continued use of this game-changing technology.”