Devices

Medtronic IDE Approved for Laser Use in Epilepsy Treatment

FDA has approved a Medtronic IDE for a pivotal study called SLATE (Stereotactic Laser Ablation for Temporal Lobe Epilepsy). The study is designed to support the expanded indication of currently marketed Visualase MRI-Guided Laser Ablation Technology for treating epilepsy in patients with drug-resistant mesial temporal lobe epilepsy (MTLE), the most common form of partial or localization-related epilepsy.

The study will include about 120 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the U.S., according to the company. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events and neuropsychological outcomes.

The Visualase system is currently 510(k) cleared to necrotize or coagulate soft tissue in neurosurgery and other surgical specialties. During a surgical procedure, laser energy is delivered to the target area using a laser applicator. “As light is delivered through the laser applicator, temperatures in the target area begin to rise, coagulating the unwanted soft tissue under real-time MRI guidance,” Medtronic 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