Devices

Baxter De Novo Granted for Theranova Dialysis Membrane

FDA has granted Baxter International a de novo application for the Theranova dialysis membrane. The company says the device was designed to deliver expanded hemodialysis therapy, which filters a wider range of molecules from the blood than traditional hemodialysis filters, like high-flux membranes, by “targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa).”

Expanded hemodialysis therapy is performed the same way as conventional hemodialysis, with only a change in dialyzer membrane required, Baxter says. “Once in the machine, the Theranova dialyzer’s innovative Medium Cut-Off membrane combines high permeability and selectivity for uremic toxins (up to 45 kDa), while retaining essential proteins and maintaining albumin levels during treatment, it says. “This unique cut-off and high retention onset profile expands clearance, allowing for filtration closer to that of the natural kidney.”

For the de novo decision, Baxter says it conducted a randomized controlled clinical study in the U.S. that evaluated the safety and efficacy of expanded hemodialysis therapy enabled by Theranova. Data from the study, which was published in the Clinical Journal of the American Society of Nephrology, found that expanded hemodialysis therapy with the Theranova 400 dialyzer provided superior removal of large middle molecules compared to a similarly sized high flux dialyzer while maintaining serum albumin levels, 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

Read more

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