AtriCure Announces Labeling Expansion for Cryo Nerve Block Therapy
January 04 2021 - 8:00AM
Business Wire
Expansion includes adolescent patients, as
young as 12 years of age, who can benefit from cryo nerve block
therapy during surgical procedures involving the chest wall.
AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments
for atrial fibrillation (Afib) and left atrial appendage (LAA)
management, today 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 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 Chief
Executive Officer. “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.”
About AtriCure, Inc.
AtriCure, Inc. provides innovative technologies for the
treatment of Afib and related conditions. Afib affects more than 33
million people worldwide. Electrophysiologists and cardiothoracic
surgeons around the globe use AtriCure technologies for the
treatment of Afib and reduction of Afib related complications.
AtriCure’s Isolator® Synergy™ Ablation System is the first and only
medical device to receive FDA approval for the treatment of
persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage
Exclusion System products are the most widely sold LAA management
devices worldwide. For more information, visit AtriCure.com or
follow us on Twitter @AtriCure.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210104005042/en/
Angie Wirick AtriCure, Inc. Chief Financial Officer (513)
755-5334 awirick@atricure.com
Valerie Storch-Willhaus AtriCure, Inc. Senior Director,
Corporate Marketing and Communications (612) 605-3311
vstorch-willhaus@AtriCure.com
AtriCure (NASDAQ:ATRC)
Historical Stock Chart
From Mar 2024 to Apr 2024
AtriCure (NASDAQ:ATRC)
Historical Stock Chart
From Apr 2023 to Apr 2024