FDA Clears OrthoSensor, Inc.'s Verasense Knee Replacement Device
Published: Jun 19, 2013
OrthoSensor(TM) Receives FDA Clearance for VERASENSE(TM) Knee System with Limb Alignment
SUNRISE, FL--(Marketwired - June 18, 2013) - OrthoSensor™, Inc., the leader in intelligent orthopedics, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VERASENSE™ Knee System with limb alignment. VERASENSE is the first intraoperative instrument system to combine quantifiable data on limb alignment, implant position and soft tissue balancing for surgeons during total knee replacement surgery.
The VERASENSE Knee System is an intelligent, low-cost, single-use instrument system that replaces the standard plastic tibial trial spacer used during knee replacement surgery. VERASENSE utilizes advanced, proprietary sensor and communications technologies to give surgeons real-time feedback on limb alignment, implant position and soft tissue balance during knee replacement. By delivering this dynamic, quantitative data, VERASENSE empowers surgeons to make evidence-based decisions regarding component placement, limb alignment and soft tissue balance to optimize clinical outcomes and enhance patient satisfaction.
VERASENSE integrates seamlessly within the current surgical workflow and is compatible for use with multiple knee implant systems. VERASENSE enables surgeons, for the first time, to rapidly make a total kinetic (force and motion) assessment of knee function and make adjustments to achieve balance and stability through a full range of motion.
"For the best patient outcomes, a knee must be both properly aligned and balanced; having the ability to quantify these two critical factors with one system is a major advance in total knee arthroplasty," said Kenneth A. Gustke, M.D., Florida Orthopedic Institute. "Inaccurate limb alignment leads to long term wear problems; improper soft tissue balance leads to postoperative pain for patients, as well as instability, stiffness and dissatisfaction. VERASENSE is an accurate, simple and affordable solution to give knee replacement patients optimal short and long term clinical outcomes."
"OrthoSensor's intelligent orthopedic technology has taken knee replacement surgery to a new level of precision that enables improved patient care," said Jay Pierce, OrthoSensor's CEO. "Traditionally, surgeons have relied on conventional instruments, personal judgment, and experience to assess soft tissue balance and limb alignment. VERASENSE advances surgeon decision-making from a feel-based art, to a quantifiable science with a low cost, easy to adopt solution that benefits all health system stakeholders and the patients they serve."
The first generation of VERASENSE with soft tissue balancing capabilities has already been adopted by over 35 orthopedic centers of excellence in the U.S.
OrthoSensor, Inc. (www.orthosensor.com) is developing and commercializing intelligent orthopedic devices that provide real-time data to surgeons and hospitals during and after surgery. OrthoSensor's intelligent orthopedic devices utilize advanced sensor and wireless communication technologies with the goal of improving healthcare outcomes and reducing the cost of treating musculoskeletal disease. The company's intelligent orthopedic instrumentation and implants are designed to enhance surgical implantation, and enable remote monitoring of implant function and overall musculoskeletal health.
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