Devices

Panel Votes Down BD’s Lutonix Balloon PTA Catheter

FDA’s Circulatory System Devices Panel has voted not to recommend approval of BD’s Lutonix drug-coated balloon PTA (percutaneous transluminal angioplasty) catheter for treating below-the-knee lesions in patients with critical limb ischemia. Panel members voted 15 to 2 in support of the device’s safety, 2 to 15 against its effectiveness, and 3 to 14 against its benefits outweighing the risks.

An FDA briefing document released in advance of the meeting (see earlier story) said that limitations associated with the primary and supplementary data in the PMA made it challenging to draw conclusions regarding the safety and effectiveness of the device. The document said that to date FDA has not noted any safety concerns associated with using the catheter that would be expected to exceed those of current standard of care with non-drug-containing devices.

“A modest benefit in regard to the primary effectiveness endpoint compared to PTA can be seen at six months but a reversed outcome was noted at 12 months and beyond,” the document said…. “Overall, the study was terminated early and did not meet the pre-specified hypothesis test success criteria. It remains unclear whether the effectiveness differences at six months are clinically meaningful and that the benefits of the paclitaxel-coated Lutonix 014 DCBN outweigh the risks compared to treatment with an uncoated balloon for treatment of atherosclerotic lesions below the knee.”

FDA says that if approved, the Lutonix device would be the first device other than PTA and atherectomy to be indicated for treating below-the-knee critical limb ischemia in the U.S.

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