AtriCure Announces Labeling Expansion for Cryo Nerve Block Therapy
January 04, 2021 at 01:00 pm
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AtriCure, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of additional labeling claims for cryo nerve block (cryoNB) therapy to include the treatment of adolescent patients (12-21 years of age). The cryoICE® and cryoSPHERE™ cryoablation probes are designed to temporarily block pain by ablating intercostal nerves under direct visualization in adolescent patients of at least 12 years of age. AtriCure’s cryoICE technology uses a unique freezing method to block nerves from transmitting pain signals for several months. Because of its long-lasting nature, physicians are adopting cryoNB therapy as part of their multi-modal pain management strategy. Adolescent patients undergoing invasive surgery of the chest wall can experience severe pain and have limited options for pain management after surgery. One of these procedures is to address structural deformities of the chest wall, a condition known as pectus excavatum. The preferred corrective procedure is a minimally invasive surgery known as the Nuss procedure and cryoNB therapy has shown to be safe and effective for post-operative pain management for adolescent patients.
AtriCure, Inc. provides technologies for the treatment for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management. The Company's cardiac ablation and left atrial appendage management (LAAM) products are used by physicians during open-heart and minimally invasive surgical procedures. Its pain management solutions are used by physicians to freeze nerves during cardiothoracic or thoracic surgical procedures. The Company's products for open and minimally invasive ablation include Isolator Synergy Clamps and Multifunctional Pens and Linear Ablation Devices. Its products for open ablation include cryoICE Cryoablation System. Its products for minimally invasive ablation include EPi-Sense Guided Coagulation System with VisiTrax Technology. Its appendage management products include AtriClip System. The Isolator Synergy Ablation System clamps are single-use disposable radio frequency (RF) products with jaws that close in a parallel fashion.