TORAX MEDICAL’S LINX® REFLUX MANAGEMENT SYSTEM RECEIVES UNANIMOUS
RECOMMENDATION FROM FDA ADVISORY PANEL
Shoreview, Minn. – January 13, 2012 – The LINX® Reflux Management System, a
novel device for the treatment of Gastroesophageal Reflux Disease (GERD),
has received a positive recommendation from the Food and Drug
Administration’s (FDA) Gastroenterology and Urology Devices Advisory Panel.
The FDA advisory panel unanimously voted yes to all three questions posed by
the FDA, affirming efficacy, safety and risk-benefit ratio for the LINX®
Reflux Management System. The advisory panel meeting was the most recent
milestone in the FDA regulatory review process for Torax Medical.
“Torax Medical is very pleased that the Gastroenterology and Urology Devices
Advisory Panel recognized the clinical benefits of the LINX System. We look
forward to working with the FDA to reach a final decision on approval to
make the LINX treatment available to patients in the United States”,
commented Todd Berg, chief executive officer of Torax Medical.
The LINX Device
The LINX Reflux Management System incorporates a small flexible band of
interlinked titanium beads with magnetic cores, which is laparoscopically
placed around the esophageal sphincter. The magnetic attraction between the
beads is intended to help the sphincter resist opening to gastric pressure,
preventing reflux from the stomach into the esophagus. Higher pressures from
swallowing can overcome the magnetic forces, allowing food and liquid to
pass normally into the stomach.
About Torax Medical
Torax Medical Inc. is a privately held medical device company headquartered
in St. Paul, Minnesota that develops and markets products designed to treat
sphincter disorders. Torax Medical’s technology platform, Magnetic Sphincter
Augmentation (MSA), is currently marketed in Europe as the LINX® Reflux
Management System for the treatment of Gastroesophageal Reflux Disease
(GERD) and the FENIX™ Continence Restoration System for the treatment of
Fecal Incontinence (FI). In the United States, the LINX System is not
approved for commercial distribution and is currently limited by Federal law
to investigational use. For more information, please visit
www.toraxmedical.com.
Contact: Colleen Simcoe
Torax Medical, Inc.
(651) 361-8900