Navigation Links
NDO Receives FDA 510(K) Clearance for Plicator II(TM)
Date:9/22/2007

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 http://www.ndosurgical.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... ... May 27, 2016 , ... In response ... many who are unaware of the plight of aphasia. In collaboration with the ... “Stroke Awareness” campaign. , The link between stroke and aphasia is relatively unknown, ...
(Date:5/27/2016)... ... 27, 2016 , ... Each year Standard Process Inc. ... is this year’s Life University winner of a $2,500 scholarship from ... Leadership Awards ceremony. , Outerbridge is approaching her last quarter at Life University ...
(Date:5/26/2016)... New Hampshire (PRWEB) , ... May 26, 2016 , ... ... skin care products, has been honored with a 2016 When Work Works Award for ... prestigious award, part of the national When Work Works project administered by the Families ...
(Date:5/26/2016)... ... 26, 2016 , ... Connor Sports, through its Connor Cares initiative, ... Tamika Catchings Legacy Tour that will commemorate the Indiana Fever legend’s hall-of-fame ... in all forms and levels of the game, Connor Sports has committed to a ...
(Date:5/26/2016)... ... , ... There are nearly 14.5 million people living with and beyond cancer ... June 5, 2016, communities around the world will gather to recognize these cancer survivors ... Survivors Day® is an annual worldwide Celebration of Life that is held on the ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... 2016 Niederländische Chirurgen haben ... es Ärzten erlaubt, ihre Expertise weltweit zu teilen ... Live Streaming mit einer Instant-Messaging-Funktion und der Möglichkeit, ... in Europa, Afrika, Asien und den ... Plattform registriert. Information und Weiterbildung   ...
(Date:5/24/2016)... , May 24, 2016   ... endpoints demonstrating non-inferiority in overall bowel cleansing and superiority ... c leansing of the ... http://photos.prnewswire.com/prnh/20130829/633895-a ) , Norgine B.V. today announced new ... litre PEG and ascorbate bowel preparation) versus standard 2 litre PEG ...
(Date:5/24/2016)... 2016  NxStage Medical, Inc. (Nasdaq: NXTM ... renal care, today announced that Jeffrey H. Burbank ... following schedule of investor conferences. Where applicable, a webcast ... http://ir.nxstage.com/ .   ... NY           Friday, June 10, 2016 1:30 p.m. ET ...
Breaking Medicine Technology: