HydroCision Inc have been issued a Medical Device License from Health Canada for the VersaJet Hydrosurgery System for wound debridement and general surgery. This regulatory clearance follows prior United States FDA 510(k) clearance and European Union CE Mark certification.
The VersaJet Hydrosurgery System enables surgeons to simultaneously hold, cut and remove damaged tissue and contaminants - without the collateral trauma associated with current surgical modalities. Debridement of traumatic wounds, chronic wounds and other soft tissue lesions can now be achieved in a single step, with a single instrument, and single-handedly. The VersaJet system precisely targets damaged tissue and spares viable healthy tissue - thereby promoting the wound healing process.
"We are now able to add Canada to the United States and Europe as our initial target markets for launching the VersaJet Hydrosurgery System," commented Chip Bevier, Director of Marketing and Sales for HydroCision Inc. "We believe the VersaJet system will enable Orthopaedic Traumatologists, Trauma Surgeons, and Plastic Surgeons to perform surgical debridement more effectively, more easily, and more economically."
HydroCision plans to enter the Canadian market this year and is seeking a national distribution partner that specializes in introducing novel surgical instruments to the operating room, particularly for orthopaedic, trauma or plastic surgery.