Devices

Elixir Med. Breakthrough Status for Bioadaptive Implant

FDA has granted Elixir Medical a breakthrough device designation for its novel bioadaptive implant, DynamX Sirolimus-Eluting Coronary Bioadaptor System, for use in improving coronary luminal diameter, restoring hemodynamic modulation, and reducing plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions.

The device is designed to return a diseased vessel to a more normal condition through three distinct phases, according to the company. “After implantation, the locked phase establishes the maximum flow lumen and restores blood flow to treat symptoms of coronary artery disease (CAD),” it says. The second phase occurs after the device is encapsulated with tissue and the absorbable polymer coating is resorbed, which allows the vessel to grow and adapt to maintain the established blood flow lumen. The third phase “provides the vessel adaptive dynamic support by the separated helical strands,” Elixir says, adding that this “restores the vessel viability and hemodynamic modulation by returning pulsatility, compliance, adaptive blood flow volume, and plaque stabilization and regression.”

Elixir notes that current interventional treatment of coronary artery disease with drug-eluting stents has been able to establish flow angiographically, but up to 20% of patients experience a repeat adverse event related to the implant within five years post-treatment.

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