Navigation Links
NDO Receives FDA 510(K) Clearance for Plicator II(TM)

Strengthens Position as the Global Leader in Endoscopic Anti-Reflux Surgery

MANSFIELD, Mass., Sept. 20 /PRNewswire/ -- 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

SOURCE NDO Surgical, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Infant receives first bloodless liver transplant
2. British MPs Say Prostate Cancer Receives Low Priority in the NHS
3. Fifth US Patient Receives Artificial Heart
4. Northfield Labs Receives FDA Comments
5. Abbott Receives CE Mark Certification
6. Zactima Receives Fast Track Designation By The FDA
7. East London Receives World Class New Private Hospital Facility
8. Brinda Karat Receives Legal Notice over Ramdev Issue
9. Quake-Hit Pakistan Receives 30 Field Hospitals From Cuba
10. Medtronic’s Insulin Pump Receives Regulatory Approva
11. Aurobindo Receives Approval from USFDA for anti-AIDS drug
Post Your Comments:
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... According to ... out by the University of Toronto and the University of British Columbia suggested that ... for head injuries. The article explains that part of the reason for the controversial ...
(Date:11/27/2015)... ... November 27, 2015 , ... The rapid speed at ... people age, more care is needed, especially with Alzheimer’s, dementia and other cognitive ... being overworked. The forgotten part of this equation: 80 percent of medical care ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, ... to dispense prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. ... dispense prescription medications. In doing so, it could help to prevent potential overdose ...
(Date:11/27/2015)... ... , ... Lizzie’s Lice Pickers just announced a special promotion that will run ... purchase of lice treatment product. In addition, customers will receive a complimentary head Check ... lice is a sure way to ruin the holidays, so we encourage all of ...
(Date:11/27/2015)... ... November 27, 2015 , ... ProSidebar: Fashion is a set of ... With ProSidebar: Fasion, video editors can easily add an informative sidebar to any FCPX ... Utilize presets featuring self-animating drop zones, lines, bars, and text with the ease ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... ) has announced ... High Viscosity Drugs" report to their offering. ... addition of the "Self Administration of High ... --> Research and Markets ( ) ... Administration of High Viscosity Drugs" report to ...
(Date:11/25/2015)... SYDNEY , Nov. 26, 2015  The total global ... nearly 7% over 2015-2016. Latin America ... Asia , (excluding Japan ), is ... continues to face increased healthcare expenditure. In 2013-2014, ... expenditure declined from 43.5% in 2008-2009 to 41.2% in 2013-2014. ...
(Date:11/25/2015)... , Nov. 25, 2015 On Tuesday, ... federal bellwether trial against Wright Medical Technology, Inc. ... their Conserve metal-on-metal hip implant device, awarded $11 ... a two week trial and three days of ... hip device was defectively designed and unreasonably dangerous, ...
Breaking Medicine Technology: