FDA Clears Covidien’s Evident™ Microwave Ablation System for Use in Nonresectable Liver Tumor Ablation

BOULDER, Colo.--(BUSINESS WIRE)--Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products , today announced that the United States Food and Drug Administration (FDA) has issued a 510(k) marketing clearance for the Evident™ Microwave (MW) Ablation System, intended for use in the ablation of nonresectable liver tumors.

“The recent FDA concurrence for the Evident MW Ablation System’s intended use for the ablation of nonresectable liver tumors is a testament to the comprehensive evidence-based approach EbD takes in the development of our products”

This new system offers a procedural option for patients who are not candidates for surgical resection and have few remaining treatment options. Its introduction reinforces the commitment to the oncology market shown over many years by Covidien’s Energy-based Devices (EbD) business unit, the world leader in advanced energy-based surgical systems.

The Evident MW Ablation System is intended for the coagulation of soft tissue during percutaneous, laparoscopic and open surgical procedures. The system uses microwave energy, emanating from the feed point of the radiating section of an antenna, to cause coagulation of the tissue. The microwave energy creates heat by generating friction through the vibration of water molecules. With microwave ablation, there is no current flow through the patient, eliminating the need for grounding pads.

“The recent FDA concurrence for the Evident MW Ablation System’s intended use for the ablation of nonresectable liver tumors is a testament to the comprehensive evidence-based approach EbD takes in the development of our products,” said Ned Cosgriff, M.D., Vice President, Medical/Clinical Affairs, Covidien EbD. “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.”

This major technological advance allows surgical oncologists, interventional radiologists, hepatobiliary surgeons and other medical specialists to perform percutaneous, laparoscopic or open surgical soft-tissue ablation, and to perform these procedures at speeds up to 60 percent faster than is possible with other ablation products. With the Evident MW Ablation System, ablations may be achieved in approximately 10 minutes. The speed and efficiency of the Evident MW Ablation System may mean less time in the operating or radiology suite for medical professionals and patients and less time under anesthesia for patients.

“As the only company to offer both microwave and radiofrequency ablation systems globally, we are proud to be the first microwave ablation company to receive FDA clearance for the ablation of nonresectable liver tumors,” said Kerr Holbrook, Vice President, Global Marketing, EbD Interventional Oncology. “At EbD, the Interventional Oncology business is focused on improving patient outcomes through the safe and effective use of technology in the oncology setting. As a company, we are committed to executing this objective in full compliance with the regulatory guidelines established by the FDA.”

ABOUT COVIDIEN

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2008 revenue of nearly $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.