OrthoDynamix has received FDA clearance for its new device ArthroSteer 3.5mm Ablator, a mono polar electrosurgical device with orthopedic and arthroscopic applications, for general surgical use.
ArthroSteer is used for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulating soft tissue in, but not limited to the knee, shoulder and primarily the hip.
ArthroSteer’s patent pending technology improves triangulation and orientation of its instruments in tight joint capsules enabling the surgeon greater access to damaged tissue. The 3.5mm and/or its 5mm high dexterity instruments have surgeon controlled 180 degree bend of the distal shaft while the tip can rotate 360 degrees on its axis, independent of the shaft.
The device is designed to withstand the rigors of arthroscopy. It is also designed for cost savings since it interfaces with many of the hospital’s current mono polar electrosurgical generators, thus additional capital equipment is not required.
Bill Dennis, CEO of OrthoDynamix, said: “ArthroSteer’s 3.5mm Ablator FDA clearance is an important step for increased sales opportunity in the US. This product complements our sports medicine portfolio of steerable ArthroSteer Punch, Grasper and Biter that are currently marketed in the US. This product portfolio is also being readied for the global market upon receipt of their CE mark.”