OrthoSensor, Inc. is excited to introduce our latest product: VERASENSETM Sensor-Assisted Technology (VERASENSE) to be used with Zimmer Biomet’s Persona®️ Knee System for total knee replacement. The product has received 510(K) clearance from the U.S. Food and Drug Administration (FDA). VERASENSE harnesses the latest innovations in sensors and wireless communications for primary and revision total knee arthroplasty (TKA), with the goals of improving patient outcomes and satisfaction. The newly released sensor for the Persona Knee System includes improved wireless communication through Bluetooth technology and an extended sensor battery life performance. Earlier this year, OrthoSensor received clearance to use VERASENSE with the Persona Knee System in Australia. Dr. Lachlan Host from Bathurst Private Hospital in Australia successfully used VERASENSE for Persona Knee System for the first time. With over 150 successful surgeries completed in Australia, we are excited to officially offer this innovative technology to the U.S. market. A randomized controlled trial proved that – without VERASENSE – TKAs are only balanced 50% of the time.1 For the first time, Persona surgeons will have a tool in their hands that quantifies knee balance, enabling reproducible and consistent patient results.
Before VERASENSE, surgeons generally relied on their “best judgment” in determining what “felt” like a balanced knee, historically resulting in one out of every five patients (20%) being dissatisfied with the results of their surgery. Common patient complaints include persistent pain, instability, stiffness and loss in range of motion.2-4 In a prospective multi-center study, VERASENSE use was proven to reduce post-operative pain, accelerate patient activity levels, improve functional outcomes, and increase patient satisfaction scores with high statistical significance.3-6 In fact, 98 percent of patients whose knees were balanced using VERASENSE reported they were satisfied to very satisfied at three years post-op.6-7 These proven results point to improved joint balance being the key to higher TKA satisfaction.
1. VERASENSE Multicenter Randomized Controlled Trial. Pending Publication. Data on file at OrthoSensor, Inc.
2. Bourne RB, Chesworth B, Davis A, Mahomed N, Charron K. Comparing Patient Outcomes After THA and TKA: Is There a Difference? Clinical Orthopaedics and Related Research. 2010;468(2):542-546.
3. Gustke KA, Golladay GJ, Roche MW, Jerry GJ, Elson LC, Anderson CR. Increased satisfaction after total knee replacement using sensor-guided technology. Bone Joint J 2014;96-B:1333–8.
4. Gustke KA, Golladay GJ, Roche M, Elson L, Anderson C. Primary TKA patients with Quantifiably Balanced Soft-Tissue Achieve Significant Clinical Gains Sooner than Unbalanced Patients. Adv Orthop. 2014: 628695.
5. Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty 2014;29:955–960.
6. 2-Year, 3-Year Clinical Outcomes, OrthoSensor Multicenter Evaluation. Pending Publication. Data on file at OrthoSensor, Inc.
7. Gustke, K., Golladay, G., Roche, M., Elson, L., Jerry, G., Anderson, C. The satisfied total knee replacement patient: 3-year multicenter study. EC Orthopedics 9.3 (2018): 122-127.