Devices

FDA Warns on Medtronic Heartware Ventricular Assist Device

FDA is warning healthcare providers about the possibility that patients who have Medtronic’s Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may instead have a welding defect in the internal pump causing the pump to malfunction. According to a just-released Medtronic Urgent Medical Device Correction, the company is conducting an investigation to identify which HVAD pumps may be affected. Meanwhile, the agency has issued a letter to healthcare providers to make them aware of the problem and recommend actions to take to manage patient care.

FDA continues to stand by a 6/2021 communication that did not recommend the elective removal of properly functioning systems. “Decisions about removing or exchanging the Medtronic HVAD System should be made by health care providers and patients on a case-by-case basis, considering the patient’s clinical status and surgical risks,” the agency says.

The HVAD is approved as a bridge to heart transplantation in patients who are at risk of mortality from end-stage left ventricular heart failure, for heart tissue recovery, and as destination therapy in patients for whom a heart transplant is not planned.

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