Devices

FDA Approves Transcend Glaucoma Device

FDA has approved a Transcend Medical PMA for the CyPass Micro-Stent System (Model 241-S), a glaucoma surgical device for use in combination with cataract surgery. The is intended to help reduce intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma.

The CyPass System comprises a CyPass Micro-Stent, contained within a loading device, and a stent delivery tool. It is placed in the angle of the eye, with the proximal end extending into the anterior chamber, and the distal end residing in the supraciliary space. This allows outflow of fluid from the anterior chamber through the distal end into the supraciliary and suprachoroidal spaces, the company says.

Approval was based on data from a 505 patient study — 374 patients were randomized to the CyPass Micro-stent in combination with cataract surgery, and 131 patients were randomized to cataract surgery alone. Of the patients randomized to the stent, 72.5% achieved a significant lowering of their IOP, compared to 58.0% of patients who had cataract surgery alone, 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