Devices

Enhanced Coronary Lithotripsy Catheter OK’d

FDA has approved a Shockwave Medical PMA for what the company calls an “enhanced” Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) catheter, indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting. Shockwave says the device provides 50% more pulses per catheter than the previous model that was approved in 2021. “The enhancements of Shockwave C2+ will be an added benefit of IVL for optimally treating complex calcium, including more diffuse disease, as well as nodular and thick, eccentric calcium,” it adds.

According to the company, the IVL catheter is delivered across a calcified lesion and the integrated balloon is expanded to facilitate energy transfer. “An electrical discharge from the emitters vaporizes the fluid within the balloon, creating a rapidly expanding and collapsing bubble that generates sonic pressure waves,” it says. “The waves create a localized field effect that travels through soft vascular tissue, selectively cracking intimal and medial calcium within the vessel wall. After calcium modification, the integrated balloon may subsequently be used to dilate the lesion at low pressure in order to maximize luminal gain.”

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