|[July 01, 2014]
New Technology Changes How Gastroesophageal Reflux Disease is Treated
ST. PAUL, Minn. --(Business Wire)--
Torax Medical today announced the release of new data from two leading
U.S. medical centers that further establishes the LINX Reflux Management
System as a safe and effective procedure for patients suffering from
gastroesophageal reflux disease (GERD).
Chronic GERD, when not completely responsive to medical therapy, can
progress to serious complications including precancerous Barrett's
esophagus and esophageal cancer. Symptoms are often debilitating and may
include daily pain, difficulty swallowing and sleep disruption. The
disease is also associated with upper respiratory problems including
asthma and bronchitis/pneumonia. Medical therapy (acid suppression
medications) commonly prescribed to address GERD symptoms do not address
the underlying cause of the disease which is a weak sphincter (valve)
between the stomach and esophagus.
C. Daniel Smith, MD, Professor of Surgery, Mayo Clinic Jacksonville,
Florida recently published his experience with the LINX Magnetic
Sphincter Augmentation System in the Journal
of the American College of Surgeons. "Our clinical experience
with the LINX System matches what has been observed in controlled
trials. Importantly, we are seeing LINX as a new treatment option for
patients who suffer from GERD despite continuous drug use. The ability
to offer patients a minimally invasive treatment which restores their
esophageal sphincter without major side effects has been a long-term
clinical need which it appears LINX can fulfill," said Dr. Smith.
A second study, recently published in the Annals
of Thoracic Surgery presents LINX outcomes by Brian Louie,
MD, Director, Thoracic Research and Education and colleagues from the
Swedish Cancer Institute and Medical Center in Seattle, Washington. The
team evaluated sphincter augmentation with LINX with case matched
sphincter reconstruction using the patient's gastric fundus (Nissen
fundoplication). Study results demonstrated that both LINX and
fundoplication provided significant improvement in GERD symptoms such as
heartburn, regurgitation and cough. However, patients implanted with
LINX had a greater ability after the procedure to belch and experienced
less bloating and gassy feelings, which are commonly associated with
laparoscopic Nissen fundoplication surgery.
"The LINX device appears to restore the sphincter barrier function and
preserve normal physiology which enables belching and vomiting," said
Dr. Brian Louie. "LINX is an important new surgical treatment option for
patients who fail medical therapy and have worsening GERD."
The LINX device has been clinically studied for over 7 years. These
studies add to the growing body of evidence that the LINX system is an
effective and medically necessary treatment in the continuum of care for
patients suffering from GERD.
Gastroesophageal Reflux Disease (GERD) is a chronic, often progressive
disease resulting from a weak lower esophageal sphincter that allows
harmful gastric fluid to reflux into the esophagus, resulting in both
pain and injury to the esophageal lining. Symptoms of GERD include
heartburn and regurgitation, often associated with chronic sleep
disruption, and may also include persistent cough, excessive throat
clearing, hoarseness and a feeling of a "lump" in the throat. Acid
reflux medications, such as Prevacid®, Nexium®,
and Prilosec®, affect gastric acid production, but do not
repair the sphincter defect, allowing continued reflux. GERD is
associated with a pre-cancerous condition known as Barrett's esophagus,
which increases the risk of esophageal cancer.
The LINX Reflux Management System
LINX is a small implant comprised of interlinked titanium beads with
magnetic cores. The magnetic attraction between the beads augments the
existing esophageal sphincter's barrier function to prevent reflux. The
device is implanted using a standard minimally invasive laparoscopic
procedure and is an alternative to the more anatomically disruptive
fundoplication, commonly used in surgical anti-reflux procedures. The
LINX® Reflux Management System is indicated for those
patients diagnosed with Gastroesophageal Reflux Disease (GERD) as
defined by abnormal pH testing, and who continue to have chronic GERD
symptoms despite maximum medical therapy for the treatment of reflux.
LINX does require a surgical procedure and is associated with potential
risks, contraindications and life style modifications. For more
information on LINX, including a statement of risks, please visit www.linxforlife.com.
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 utilizing its technology platform,
Magnetic Sphincter Augmentation (MSA). Torax Medical is currently
marketing the LINX® Reflux Management System for the
treatment of GERD in the U.S. and Europe and the FENIX™ Continence
Restoration System for the treatment of Fecal Incontinence (FI) in
Europe. For more information, please visit www.toraxmedical.com.
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