Devices

preCardia Gains ‘Breakthrough’ Status for ADHF Device

FDA has granted preCardia, Inc., a breakthrough device designation for its catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF). The device is intended to rapidly reduce congestion in the venous system, known as cardiac preload, thereby improving overall cardio-renal function, the company says. The potential benefits for patients include improved response to medical management, reducing rehospitalizations, and improved quality of life, it says. The system is currently under investigation in the VENUS-HF Early Feasibility Study.

The company says its proprietary balloon catheter and pump controller is designed to address ADHF through intermittent superior vena cava occlusion. By limiting venous return to the heart, the device treats fundamental ADHF clinical hemodynamic targets, it says.

preCardia says about 1.8 million patients are admitted to hospitals with ADHF in the U.S. annually and it is the leading cause of hospitalization in patients older than 65 years of age. Mortality after ADHF hospitalization is about 30% annually and readmission is common, despite available pharmacotherapy and device-based heart failure treatments. “There remains a need for new therapies focused on providing effective and efficient cardio-renal volume unloading in the ADHF patient population,” it says.

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