Healthcare Technology Featured Article

June 28, 2013

FDA Grants OrthoSensor Clearance for its VERASENSE Knee System

OrthoSensor, Inc., a company specializing in intelligent orthopedics, concentrates on conditions involving the musculoskeletal system. Through research and development it has devised new intelligent, low-cost implantable sensor systems for orthopedic surgeons to provide knee, hip, joint and shoulder replacements for patients; thus far, their results have provided optimal short and long term clinical outcomes.

The company’s newest product, VERASENSE Knee System, is an intelligent surgical device that quantifies joint loading and balance. It is compatible for use with multiple knee implant systems.

Primarily, the orthopedic device was created to be an easy-to-use high-quality telemetry solution containing embedded sensors and customized circuitry to give surgeons invaluable data on alignment and implant positions in a knee replacement procedure. It is intended to reduce the incidence of misalignment and ligament imbalance for post total knee arthroplasty (TKA), also known as total knee replacement.

According to Kenneth A. Gustke, M.D., Florida Orthopedic Institute, the VERASENSE Knee System with limb alignment “is a major advance in total knee arthroplasty.”

As Jay Pierce, chief executive officer (CEO) of OrthoSensor, stated, the VERASENSE has taken knee replacement surgery to a new level of precision and provides an “easy to adopt solution that benefits all health system stakeholders and the patients they serve.”

Furthermore, he mentioned that it also gives surgeons real-time feedback on soft tissue balance during knee-replacement surgery and quantitative data that surgeons can integrate with their judgment, experience and skill set to help improve patient care and make better evidence-based decisions.

The VERASENSE Knee System has proved to be a valuable next-generation knee replacement product for surgeons to improve patient outcomes and decrease actual TKA failures. Even so, like all devices and instruments used for surgery, it required the U.S. Food and Drug Administration (FDA) approval (or at least be cleared) before it could be used in orthopedic surgery rooms.

OrthoSensor's CEO announced on June 18 that the company’s first intraoperative “instrument system that replaces the standard plastic tibial trial spacer used during knee replacement surgery” has been granted clearance by FDA for VERASENSE.

The CEO was pleased to know that FDA vouched for its newest surgical with soft tissue balancing capabilities and sees how it can benefit knew replacement patients.

As of today, it has been reported that OrthoSensor’s first generation of VERASENSE has been quickly adopted by over 35 orthopedic centers in the U.S. already.

Knee replacements are already increasing throughout North America, and are expected to expand by another 673 percent by the year 2030, as declared by the National Center for Health Statistics (NCHS), which provides U.S. public health statistics. AS such, one can be certain that there will be many patients seeking personalized solutions like the VERASENSE Knee System.

Alternatively, there is the VISIONAIRE patient-matched technology for total knee replacement by Smith & Nephew, which also allows surgeons to achieve precise alignment customized to patients’ knees.

Edited by Alisen Downey

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