Devices

FDA Approves Biotronik PRO-Kinetic Coronary Stent

FDA has approved a Biotronik PMA for PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System and its use to improve coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries. The ultra-thin, 60 µm strut thickness of the stent “allows for optimal deliverability under the most extreme conditions of tortuosity and calcification,” the company says. It is indicated for patients who have a blockage in arterial vessels between 2.25 and 4.0 mm in diameter and lesion lengths up to 31 mm.

Approval is based on data from the multi-center BIOHELIX–I trial involving 329 patients at 33 sites worldwide. “At nine months, the stent demonstrated a target vessel failure rate of just 9.06%, less than half of the identified performance goal of 18.7%,” Biotronik says. These positive results confirm the clinical success found in other PRO-Kinetic Energy trials. At 12 months, the stent showed a low rate of major adverse cardiac events at 8.1%, including a 4.9% rate of target lesion revascularization, 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