OrthoSensor Receives 510(k) Alignment Clearance For VERASENSE™

OrthoSensor, Inc. announced today it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Alignment capabilities with VERASENSE^™ Sensor-Assisted Technology, (VERASENSE), the only single-use intelligent sensor that measures tibial coronal alignment and quantifies soft-tissue balance when used with the Zimmer Biomet Persona Knee implant system (Persona).

VERASENSE^™ is a sensor-assisted device used with leading knee implant systems during primary and revision Total Knee Arthroplasty (TKA). This technology transmits real-time data to a display unit in the operating room, which enables surgeons to make informed decisions about soft tissue balance and implant alignment. These are two major factors that contribute to the success of TKAs.

Dr. Martin Roche, Orthopedic Surgeon and Chief Medical Officer of OrthoSensor, Inc., said: “The ability to achieve optimal knee stability, implant congruency and alignment through the full range of motion is critical. The data that is provided from the single-use VERASENSE sensor will enable surgeons at hospitals and ambulatory surgery centers to make objective assessments intraoperatively of soft-tissue balance and knee alignment with the Persona implant system for the best possible patient outcomes¹.”

“This FDA clearance of our Alignment technology for VERASENSE with Zimmer Biomet Persona is a great milestone for OrthoSensor.  OrthoSensor has always been committed to quantifying orthopedics through sensor-assisted technology and enable healthcare providers globally with evidenced-based treatments that improve clinical and economic outcomes for patients and healthcare stakeholders.  Our goals are not limited to knees; our innovations have expanded with the recent launch of our reverse shoulder device and will continue to expand to other orthopedic applications.  Our vision is to continue to lead the digital evolution of musculoskeletal care,” said Ivan Delevic, President and CEO of OrthoSensor, Inc.

¹ 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.^1-3 Before VERASENSE; surgeons generally relied on their “best judgment” in determining what “felt” like a balanced knee or what “looked” well aligned.

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.^6-10

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.^2-5 In fact, 98 percent of patients whose knees were balanced using VERASENSE reported they were satisfied to very satisfied at three years post-op.^2-5 These proven results point to improved joint balance being the key to higher TKR satisfaction.

References:

1. Bourne RB, Chesworth B, Davis A, Mohamed N, Charron K. Comparing patient outcomes after THA and TKA: is there a difference? Clin Orthop Relat Res. 2010; 468: 542-546.
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 sensor-guided 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.