Devices

Device Panel Votes Down Neovasc’s Reducer

FDA’s Circulatory System Devices Advisory Panel has voted 13 to 3 against recommending PMA approval for Neovasc’s Reducer for treating patients with refractory angina pectoris despite guideline-directed medical therapy, and who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.

Several committee members agreed with FDA reviewers that more data are needed before approval could be granted, especially long-term data on safety and effectiveness. An agency briefing document noted that the company provided limited data from three animal studies performed using the current device along with a prior model. The studies provided preliminary information and it “raised concerns regarding the quality and consistency of the data, the level of documentation, unclear timelines, and concerns regarding the degree of tissue coverage and endothelialization of the Reducer device,” it said.

The Neovasc Reducer System comprises an implantable Reducer device pre-mounted on a balloon catheter delivery system. The device is designed to establish a narrowing in the coronary sinus, which is intended to improve perfusion to ischemic myocardium in the presence of reversible ischemic heart disease to alleviate the symptoms of refractory angina, FDA says. Device implantation is performed through percutaneous access through the right internal jugular vein into the coronary sinus.

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