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June 11, 2018
Orthosensor Secures Additional 510(K) Clearance
DANIA BEACH, Fla., June 11, 2018 — OrthoSensor, Inc., a leader in sensor-assisted technology for total knee replacement (TKR), today announced it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its VERASENSE* Sensor-Assisted Technology (VERASENSE) to be used with Zimmer Biomet’s Persona Knee System for total knee replacement. VERASENSE harnesses the latest innovations in sensors and wireless communications for primary and revision total knee replacement (TKR) during surgery, with the goals of improving patient outcomes and satisfaction.
Said Ivan Delevic, President and Chief Executive Officer of OrthoSensor, Inc.: “Receiving FDA clearance for VERASENSE use with the Zimmer Biomet Persona Knee System, augments this outstanding implant and instrumentation, securing a better-balanced knee after surgery. The VERASENSE device brings real-time, quantified soft tissue balance data to our surgeons. This evidenced-based data regarding soft tissue balance works with systems such as Persona so that surgeons can make objective assessments intraoperatively, resulting in better clinical outcomes for patients.”
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. Dr. Host said, “Using VERASENSE has completely changed my joint arthroplasty practice. Since using VERASENSE, I have found patients have consistently improved range of motion and have had less focal pain. I now know, irrefutably, that I am achieving improved patient outcomes.”
Historically, roughly one in every five TKR patients (~20%) is dissatisfied with the results of their surgery. Common patient complaints include persistent pain, instability, stiffness, and loss in range of motion (See References 1-3 below). Before VERASENSE; surgeons generally relied on their “best judgment” in determining what “felt” like a balanced knee.
The subjectivity of total knee replacement, coupled with improper soft tissue balance and implant position, may result in premature implant failure and the need for revision surgery in the future (see References 6-10 below).
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 (see References 2-5 below). In fact, 98 percent of patients whose knees were balanced using VERASENSE reported they were satisfied to very satisfied at three years post-op (see References 2-5 below). These proven results point to improved joint balance being the key to higher TKR satisfaction.
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2. Gustke K, Golladay G, Jerry G, Roche MW, Elson LC, Anderson CR. Increased Patient Satisfaction After Total Knee Replacement Using Sensor-Guided Technology. Bone Joint J. 2014 Oct;96-B(10):1333- 8.
3. 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.
4. Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensorguided TKA. J Arthroplasty 2014;29:955–960.
5. 2-Year, 3-Year Clinical Outcomes, OrthoSensor Multicenter Evaluation. Pending Publication. Data on file at OrthoSensor, Inc.
6. Parratte S, Pagnano MW. Instability after total knee arthroplasty. J Bone Joint Surg Am 2008; 90: 184–94.
7. Bozic et al. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res.2010; 468(1):45–51.
8. Lombardi AV Jr1, Berend KR1, Adams JB1. Why knee replacements fail in 2013: patient, surgeon, or implant? Bone Joint J. 2014 Nov;96-B(11 Supple A):101-4.
9. Schroer WC, Berend KR, Lombardi AV, et al. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplasty 2013;28(8 Suppl):116–119.
10. Rodriguez-Merchan, EC. Instability Following Total Knee Arthroplasty. HSSJ. Oct 2011; 7(3): 273–278.