Devices

FDA OK’s Shockwave Coronary Artery Plaque Buster

FDA has approved a Shockwave Medical PMA for its Intravascular Lithotripsy (IVL) to treat severely calcified coronary artery disease. The sonic pressure wave therapy is intended to pass through soft arterial tissue to disrupt calcified plaque by creating a series of micro-fractures. “After the calcium has been cracked, the artery can be expanded at low pressure and a stent safely implanted to improve blood flow, with minimal trauma to normal arterial tissue,” the company says.

The approval is based on data from a a pivotal study, recently published in the Journal of the American College of Cardiology, which confirmed that coronary IVL met both the primary safety and effectiveness endpoints with a low rate of major adverse events and a high rate of procedural success, Shockwave says. “Notably,” it adds, “coronary IVL was simple to use and demonstrated a low risk of rare but life-threatening complications that have been associated with the use of high-pressure balloons and atherectomy technologies, including tears in the artery, abrupt arterial closure and a sudden stop of blood flow.”

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