Devices

Revised Safety Alert on Alcon’s CyPass Micro-Stent

FDA has issued a revised safety alert on Alcon’s CyPass Micro-Stent, a small tube with tiny holes that is surgically implanted in the eye, due to its risk of eye damage. The device is used to drain fluid that causes high eye pressure and vision loss in people with glaucoma. In 2016, it was approved for use during cataract surgery to reduce eye pressure in adults with the most common type of glaucoma, open-angle glaucoma.

The agency says that patients who have the device implanted are at risk of losing cells in the protective outer layer of the eye (cornea). “Endothelial cells line the inner surface of the eye's cornea and are important in keeping vision clear,” it says. “These cells do not regrow after they are damaged. Endothelial cell loss may be associated with damage to the cornea including swelling, cloudiness, eye pain, reduction in vision, and the potential need for corneal transplant.”

The revised alert also provides post-approval study data that has been reviewed and confirm the earlier concerns. Key findings include:

At five-year follow-up, 27.2 % (44/162) of implanted patients had more than 30% loss in endothelial cell density.
Data suggests a correlation between the amount the CyPass device extends into the anterior chamber of the eye, assessed by the number of visible retention rings on the device, and the rate of endothelial cell loss.

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