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