Covidien’s microwave ablation system for liver tumours gains FDA clearance

8 January 2009

Covidien (NYSE: COV, BSX: COV) has received US FDA clearance for the Evident microwave ablation system, which is intended for use in the ablation of nonresectable liver tumours.

This new system offers a procedural option for patients who are not candidates for surgical resection and have few remaining treatment options.

The Evident 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, MD, 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% 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 system may mean less time in the operating or radiology suite for medical professionals and patients and less time under anaesthesia 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 tumours,” said Kerr Holbrook, Vice President, Global Marketing, EbD Interventional Oncology.

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