HydroCision Inc announced that the Food and Drug Administration has granted 510(k) clearance to market its fluidjet-based hydrosurgery system for open and arthroscopic spinal surgeries. This regulatory clearance follows prior European Union CE Mark certification.
The fluidjet-based hydrosurgery system will enable spine surgeons to cut and remove soft tissue, ablate and shape hard tissue or bone more precisely and rapidly than they can with current techniques. The system also will avoid the collateral trauma associated with other surgical modalities. Additionally, the proprietary design of the device gives the ability to selectively remove tissue, which provides unique procedural advantages to the spine surgeon.
"The fluidjet for spinal surgery represents a major breakthrough in spine surgery. It will be our third market entry and is a great complement to the ExoJet Tissue Resection System for arthroscopic joint procedures and the VersaJet Hydrosurgery System for surgical debridement," commented Doug Daniels, President of HydroCision, Inc. "We believe our fluidjet-based hydrosurgery system will provide the spine surgeon with a significant advancement in their surgical tools and enable them to perform spinal procedures more effectively, more easily, and more economically." HydroCision plans to enter the US and European MIS spine markets in the second half of 2003.