AtriCure Receives FDA Clearance to Expand its Labeling for Cryo Nerve Block Therapy

AtriCure Inc., an innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, 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 collaborated with the UCSF-Stanford Pediatric Device Consortium (PDC) on a real-world evidence study and a prospective clinical trial in support of expanded adolescent labeling. The UCSF-Stanford PDC is funded by the FDA’s Office of Orphan Products Development to help pediatric device innovators accelerate high-value, high-impact solutions towards commercialization and clinical use. “The PDC is proud to be pioneering the use of real-world evidence in helping get critically needed medical devices marketed for pediatric use more efficiently and cost-effectively,” said Dr. Benjamin Padilla, Pediatric Surgeon at Phoenix Children’s Hospital. “The collaboration speaks to the heart of what the PDC is all about: bringing together government, academia and industry to find creative ways to overcome forces that all too often leave pediatric patients out of the gains of innovation.”
 
“Cryo nerve block therapy has proven to be an effective way to temporarily block pain,” said Michael Carrel, president and CEO. “Pain is a significant factor in quality of life, and we are pleased that the adolescent label expansion gives us the opportunity to positively impact the experience of younger patients recovering from surgery of the chest wall.”