Devices

Valcare Gets FDA Green Light for Heart Study

FDA has approved a Valcare Medical IDE to assess the safety and functionality of its AMEND Trans-Septal System for treating patients with mitral insufficiency. The company says the device is designed for transcatheter mitral annuloplasty and “features a semi-rigid, closed, D-shaped annuloplasty ring that replicates the current surgical gold standard for mitral valve repair.”

The study will enroll up to 15 patients across seven investigational centers in the U.S. to evaluate its effectiveness in treating patients with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation, and who are anatomically appropriate for the procedure, according to the company.

The study is intended to assess patient outcomes such as stroke, myocardial infarction, cardiovascular surgery related to device complications, and overall mortality at 30 days and six months post-implantation, Valcare says. Secondary measures will include changes in patients’ New York Heart Association (NYHA) functional class, results from the 6-Minute-Walk Test, quality of life assessments, and reductions in mitral regurgitation severity.

Key endpoints for the trial will focus on the safety and performance of the device, including successful ring delivery, implantation, and retrieval. Patient outcomes such as stroke, myocardial infarction, cardiovascular surgery related to device complications, and overall mortality will be monitored at 30 days and six months post-implantation.

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