FDA Clears Verasense™ Knee System To Optimise Joint Replacement Outcome

OrthoSensor™, Inc., has already announced partnership agreements with both Biomet and Stryker, who will co-market the company’s Verasense intraoperative knee system. Now the system has been FDA 510(k) cleared for market.

Background

The VERASENSE™ Knee System with limb alignment 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 system is intended to replace the standard plastic tibial trial spacer used during knee replacement surgery. It utilises advanced, proprietary sensor and communications technologies to give surgeons real-time feedback on limb alignment, implant position and soft tissue balance during knee replacement, thereby empowering surgeons to make evidence-based decisions regarding component placement, limb alignment and soft tissue balance to optimize clinical outcomes and enhance patient satisfaction.

OrthoSensor says Verasense integrates seamlessly within the current surgical workflow and is compatible for use with multiple knee implant systems, as evidenced by the aforementioned Stryker and Biomet co-marketing deals. The system 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.

Physician comments

“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.”

Company comments

“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.”

Source: OrthoSensor, inc., MarketWire