NDO Receives FDA 510(K) Clearance For Plicator II(TM)

Main Category: Acid Reflux / GERD
Also Included In: Regulatory Affairs / Drug Approvals;  IT / Internet / E-mail;  Clinical Trials / Drug Trials
Article Date: 21 Sep 2007 - 0:00 PDT

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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 http://www.ndosurgical.com.

NDO Surgical, Inc.
http://www.ndosurgical.com