Devices

FDA Clears Pelvalon’s Eclipse System for Bowel Control

FDA has cleared a Pelvalon 510(k) for its next generation Eclipse System for women suffering from loss of bowel control. According to the company, it is the first vaginal insert designed to provide immediate bowel control. The original version of the device was granted marketing clearance under the de novo classification process last year.

The company says the system is placed in the same location as a tampon or a diaphragm, contains no hormones or drugs, and can be removed at any time. A detachable pump is used to inflate and deflate a balloon on the insert. When inflated, the balloon works to control the rectum and prevent stool from passing, it says. When a patient is ready for a bowel movement, the balloon is deflated.

Pelvalon adds that the updated Eclipse System includes a new trial insert that allows patients to easily evaluate the therapy and decide whether it works for them, plus new sizing tools so that physicians can customize the fit of the insert for their patients.

A trial of 61 women successfully fit with the Eclipse System demonstrated effectiveness for 86 % of women who used the insert for a month, according to the company, with no serious device-related adverse events. The system will be available in Alabama, Illinois, and California and in additional areas soon, it 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