FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a Medtronic PMA for its Melody Transcatheter Pulmonary Valve (TPV) and its implanted use in patients whose surgical bioprosthetic pulmonary heart valves have failed. The device is designed specifically for the pulmonic position. It is placed inside a failing pulmonic surgical heart valve through the recently launched Ensemble II Delivery System, a low-profile, delivery catheter, specifically designed to deliver the valve.

FDA has cleared a Toshiba Medical 510(k) for the Aplio i900 ultrasound platform. “Ideally suited for contrast, fetal, pediatric, stress echo and transesophageal echocardiography imaging, the Aplio i900 delivers extreme processing power which helps healthcare providers see more in their ultrasound exams due to thinner beam slices and more return information in each image,” the company says.

FDA has cleared a Medtronic 510(k) for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection, an advanced cardiac monitor offering designed to identify abnormal heartbeats. The device offers “exclusive algorithms that result in a 95% reduction in false bradycardia (slow heartbeat) episodes and a 47% reduction in false pause (brief absence of cardiac activity) episodes when compared with its predecessor, the Reveal LINQ ICM,” the company says. The device also features a self-learning atrial fibrillation algorithm, which learns and adapts to a patient's heart rhythm over time.

DRUGS

FDA has approved Novartis’s Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is a CDK4/6 inhibitor, and it was approved based on a first-line Phase 3 trial that met its primary endpoint early — demonstrating statistically significant improvement in progression-free survival compared to letrozole alone at the first pre-planned interim analysis.

FDA has approved Merck’s Keytruda (pembrolizumab) for treating adult and pediatric patients with refractory classical Hodgkin lymphoma, or who have relapsed after three or more prior lines of therapy. The accelerated approval was based on tumor response rate and durability of response, according to the company.

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