NDO Surgical, Inc. (NDO)
announced that the US Food and Drug Administration (FDA) cleared the
Company's Plicator II(TM) multiple implant technology for immediate sale
and distribution. Plicator II technology offers improved outcomes for
harder-to-treat gastroesophageal reflux disease (GERD) patients.
"This clearance and the subsequent launch of next-generation
Plicator(R) technology strengthen our global leadership position in
endoscopic anti-reflux surgery," said Bernard Haffey, President and CEO of
NDO. "More patients can now choose the Plicator procedure with confidence
in its associated safety and efficacy."
FDA clearance of the new Plicator technique was based on agency review
of a multi-center, forty patient clinical trial in which eighty percent
(80%) of treated patients experienced superior GERD symptom control at 6
months post-treatment. Seventy percent (70%) of treated patients recorded
6-month GERD-HRQL (health-related quality of life) scores that were better
than the scores recorded while patients were being treated for GERD with
proton pump inhibitor (PPI) medications.
"Plicator technology is currently the best endoluminal GERD treatment
on the market and occupies a critical place in our treatment algorithm,"
said Lee Swanstrom, MD, Program Director of Minimally Invasive Surgery at
Legacy Health System in Portland, Oregon. "For selected reflux patients,
Plicator affords excellent symptom relief and normalized acid exposure. I
look forward to treating an even larger segment of my GERD patients by
incorporating the Plicator II multiple implant technique into our
practice."
In addition, the study demonstrated significantly reduced esophageal
acid exposure, improved esophageal manometry and lowered esophagitis scores
together with a markedly reduced dependency on GERD medications. Results
achieved in this study represent an improvement over previously reported
treatment outcomes using a single implant treatment technique with improved
outcomes achieved in a more difficult to treat patient population.
About NDO Surgical
Based in Mansfield, Mass., NDO Surgical, Inc. (NDO) is a leader in
flexible endoscopic technologies that enable surgical procedures through
the body's natural openings. The company's first product, the Plicator,
treats gastroesophageal reflux disease (GERD), a debilitating condition
that affects 15M Americans. The Plicator is also the leading gastric
closure device for Natural Orifice Translumenal Endoscopic Surgery (NOTES)
research procedures. Investors include Versant Ventures, Polaris Ventures,
and Menlo Ventures. Additional information is available at the Company's
website at ndosurgical.
NDO Surgical, Inc.
ndosurgical