Devices

FDA Approves Device for Clogged Ear Disorder

FDA has approved an Acclarent de novo petition to permit marketing of the Aera Eustachian Tube Balloon Dilation System for treating persistent eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear. The device allows a physician to use a catheter to insert a small balloon through the patient’s nose and into the eustachian tube. Once inflated, the balloon opens up a pathway for mucus and air to flow through, which may help restore proper function. After the eustachian tube is dilated, a doctor deflates and removes the balloon.

Approval was based on data from 299 patients with chronic ETD. Participants’ middle ear function was tested using a tympanogram, a method of measuring mobility of the ear drum and pressure inside the ear. “Of the patients who underwent the Aera system procedure, 52% had tympanogram results within a normal functioning range six weeks after the procedure, compared to 14% of the patients who were treated only with conventional medical management (nasal spray),” an agency release says.

The most common adverse events seen with the device are small tears of the lining of the eustachian tube, minor bleeding and worsening of ETD. Patients under the age of 22, patients who have a carotid artery that protrudes through a gap in the bone surrounding the Eustachian tube or patients whose eustachian tube is always open should not use the device, FDA says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome