Devices

SynCardia Driver System Problems Continue: FDA

An FDA update to transplant surgeons and cardiologists says that additional data continue to indicate that there is a higher mortality rate for a subgroup of patients requiring pre-implant circulatory rescue interventions when using SynCardia’s Temporary Total Artificial Heart Companion 2 Driver System, as compared to the previous driver, the Circulatory Support System console. FDA says the additional data also appear to show a higher risk of neurological adverse events for patients supported by the Companion 2 Driver compared to patients supported by the earlier console.

The update says the agency also is aware of reports of serious life-threatening malfunctions involving a third pneumatic driver system, the SynCardia Freedom Driver System. Those reported malfunctions included sudden cessation of pumping without alarms or recognizable signs of impending malfunction.

FDA urges healthcare providers to carefully consider the mortality and neurological adverse event results and device malfunction reports when making treatment decisions and device selections, and discuss risks and benefits with patients.

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