Archive for December, 2010

18.12.2010 Uncategorized No Comments

FDA approves Cryoballoon Ablation for PAT.

Medtronic Receives FDA Approval for First and Only Cryoballoon Ablation Treatment in the U.S. for Paroxysmal Atrial Fibrillation

New Arctic Front® Cardiac CryoAblation Catheter System Reduces Symptoms for Patients with Common Heart Rhythm Disorder

MINNEAPOLIS – December 17, 2010 – Medtronic, Inc. (NYSE:MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved its Arctic Front® Cardiac CryoAblation Catheter system, the first and only Cryoballoon in the United States indicated for the treatment of drug refractory paroxysmal atrial fibrillation (PAF). The Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.

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17.12.2010 news 1 Comment

FDA revokes Avastin approval for breast cancer.

Genentech imageWASHINGTON (AFP) The US Food and Drug Administration said Thursday that Avastin is not an effective treatment for breast cancer and said it would take steps to revoke market approval and change the drug’s label.

Acting on the advice of an expert panel earlier this year, the FDA said the drug, also known as bevacizumab, carries risks such as severehigh blood pressure and hemorrhage and does not prolong overall survival in women suffering from breast cancer.

Meanwhile, European experts urged restricting the drug’s use to be combined with just one type of chemotherapy, instead of with several as is the current practice.

The FDA “is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use,” it said in a statement.

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