Drugs

Abiomed Recalls Impella Blood Pumps

Abiomed is recalling (Class 1) its Impella Left Sided Blood Pumps because the pump catheter may slice the heart’s left ventricle wall during operations. “The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death,” a recall notice says. The company says there have been 129 reported serious injuries, including 49 deaths.

The devices are used for short-term support of the heart’s pumping chambers (ventricles) during high-risk catheter-based procedures (percutaneous coronary interventions). They are also used when there is “ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy,” the notice says. “Impella therapy aims to reduce the work of the heart's ventricles and provide support for the circulatory system so the heart has time to recover.”

Late last year, Abiomed sent users an urgent medical device correction letter that advised them to adhere to new and revised warnings, such as:

Carefully position the pump catheter during operative procedures
Use imaging when advancing or torquing the pump catheter
Use special care when inserting the pump catheter in patients with certain high-risk conditions
Review the updated Instructions for Use

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