Devices

Stryker Ends Trevo Retriever Stroke Trial Early

Stryker has ended patient enrollment early in its DAWN clinical study comparing mechanical thrombectomy with the Trevo Retriever plus medical therapy against medical therapy alone. An independent data safety monitoring board recommended stopping enrollment based on a pre-planned interim review of data from the first 200 patients, “which concluded that multiple pre-specified stopping criteria were met,” the company says. The study was designed to enroll up to a maximum of 500 patients with a pre-specified interim analysis to assess efficacy in the first 200 patients. A final data analysis will be conducted upon completion of the remaining patient follow-up.

The Trevo Retriever is a tiny stent-shaped device that is attached to a thin wire. “In a minimally invasive procedure that utilizes X-ray, the physician navigates the retriever from the femoral artery (located in the upper leg) to the blocked blood artery in the brain,” the company says. “The retriever is designed to ensnare the blood clot and remove it from 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

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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