Devices

FDA Approves First Leadless Pacemaker

FDA has approved a Medtronic PMA for the Micra Transcatheter Pacing System, the first pacemaker that does not require wired leads to provide an electrical connection between the pulse-generating device and the heart. The self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart, an FDA release says.

“The leads in a traditional single chamber pacemaker run from the pacemaker, implanted under the skin near the collarbone, through a vein directly into the heart’s right ventricle; the leads deliver electric pulses from the generator to the right ventricle and help coordinate timing of the chamber’s contractions,” the agency says. “Micra eliminates these leads, which can sometimes malfunction or cause problems when infections develop in the surrounding tissue, requiring a surgical procedure to replace the device.”

Approval was based on data from a clinical trial involving 719 patients implanted with the Micra device. The data showed that 98% patients in the trial had adequate heart pacing six months after the device was implanted. Complications occurred in fewer than 7% of participants in the clinical trials and included prolonged hospitalizations, blood clots in the legs and lungs, heart injury, device dislocation and heart attacks.

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