RITA MEDICAL'S HABIB4X RESECTION DEVICE GETS 510(K)
Medical devicemaker RITA Medical Systems has received FDA 510(k) clearance for its Habib4x Resection device for use in vascular tissue coagulation during surgical resection.
The Habib4x device coagulates a "surgical resection plane" using a radio frequency-energy emitting electrode to facilitate a fast dissection with limited blood loss. This technology will be utilized in liver cancer surgeries as it is designed to minimize blood loss and blood transfusion during surgery, the company said. Additionally, Habib4x is designed to work on the current RITA RFA (radio frequency ablation) platform of 1500X generators.
RITA Medical expects to begin shipping the device throughout the U.S. in mid-September. The device is already cleared for sale in the European Union.