Devices

Abbott’s Leadless Pacemaker Approved for Slow Hearts

FDA has approved Abbott’s Aveir VR single-chamber leadless pacemaker for treating patients with slow heart rhythms. The device is implanted directly inside the heart’s right ventricle and the leadless pacemaker does not require an incision in the chest or cardiac leads to deliver therapy, according to the company.

Abbott says the device has a mapping capability designed to allow physicians to measure electrical signals within the heart and determine the correct implant placement. It also has an increased projected battery life that can be up to two times longer than current leadless pacemakers. And it says it is the only leadless pacemaker designed to be retrieved if therapy needs evolve.

Approval is based on data from the global LEADLESS II Phase 2 study evaluating Aveir VR in patients with certain abnormal heart rhythms. It showed the device met its pre-specified primary endpoints, according to Abbott. The findings from the study were d published in the Journal of the American College of Cardiology: Clinical Electrophysiology.

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