Drugs

FDA Flags Abiomed, Oscor Correction of Impella Catheter Introducers

Abiomed and manufacturing partner Oscor have issued a correction (Class 1 recall) for certain catheter introducers used with Impella heart pumps after identifying a potential for leakage that could result in serious bleeding, according to an FDA notice. The introducers are intended to provide access for introducing catheters into the body.

The affected 14Fr and 23Fr introducers may leak from the sidearm, underneath the sheath cap, or along score lines in the hub region because of certain manufacturing issues, the agency says, adding that the leakage can cause blood loss during sheath insertion or early device manipulation and may require medical intervention, including device exchange or removal, manual compression or blood transfusion.

In patients undergoing large-bore vascular access while receiving systemic anticoagulation, or in patients with limited physiologic reserve, an undetected bleed could result in life-threatening hemorrhage, hemodynamic instability and death, the notice says. As of 4/22, Abiomed had reported eight instances of major bleeding and three complaints associated with patient deaths. The company determined that the reported deaths were not attributable to leakage from the introducers, it says.

The Abiomed introducer is intended to provide access for introducing catheters into the body.

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

Read more

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