FDA Reports Deaths With Medical Device used to remove lung tumors

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FDA Reports Deaths With Medical Device used to remove lung tumors

December 13th, 2007 amy

The FDA has reported that patients have died when surgeons use a medical device to remove lung tumors. All the reports involved ablation surgery to eliminate lung tumors, a use the agency has not approved.

The FDA said it has received reports of deaths connected with radio-frequency ablation systems, which generate extreme heat to destroy diseased or damaged tissue. The systems usually consist of an energy generator and an attachment, such as a catheter, which is used on the patient’s tissue.

The FDA said if doctors want to treat a patient with lung tumors using ablation, they should enroll the patient in one of several ongoing clinical trials.

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