FDA Policy/General

Product Approval Summaries

DEVICES

FDA has expanded approval for an Abiomed PMA for the Impella CP heart pump and its use in high-risk percutaneous coronary interventions (PCI). In 2016, the agecny approved Impella CP for up to four days of use to treat patients suffering from cardiogenic shock. The expanded approval allows for the device’s use for less than six hours for ventricular support during high risk PCI performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option.

FDA has cleared an Exact Imaging 510(k) for its ExactVu micro-ultrasound system for urological procedures. The device provides a resolution down to 70 microns, which is a 300% improvement in imaging resolution compared to traditional standard-of-care urological ultrasound systems, according to the company.

DRUGS

FDA has approved Genentech’s Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for treating patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

FDA has approved a new indication for Eli Lilly’s Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and cardiovascular disease. The approval is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control.

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