FDA Gives Green Light to Covidien Surgical System

The FDA has cleared the way for Covidien’s Evident brand microwave ablation system, intended for use in removing nonresectable liver tumors.

The new system provides an option for patients who do not qualify for surgical resection and have few treatment options, according to the Bermuda-based healthcare product company.

The Evident system uses microwave energy to coagulate soft tissue during percutaneous, laparoscopic and open surgical procedures. The microwave energy creates heat by generating friction through the vibration of water molecules. No current flow through the patient when microwave ablation is used, eliminating the need for grounding pads, the company said.

The technology allows medical specialists to perform percutaneous, laparoscopic or open surgical soft-tissue ablation at speeds up to 60% faster than with other ablation products, according to the release. The Evident system allows ablations to be completed in about 10 minutes.

 “As with any new technology, particularly one involving medical devices, training is essential for a product to be successful in today’s healthcare environment. With the recently granted FDA clearance, our Interventional Oncology professionals can now train healthcare providers in the safe and effective use of the Evident MW Ablation System for the specific indication of ablation of nonresectable liver tumors,” said Ned Cosgriff, M.D., vice president of medical/clinical affairs at Covidien.