Navigation Links
NDO Receives FDA 510(K) Clearance for Plicator II(TM)
Date:9/20/2007

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:6/26/2016)... , ... June 26, 2016 , ... On June 10-11, ... of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, ... the city’s history as home to some of the world’s leading providers of cereal ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts ... applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention ... health care topics including advance care planning, healthcare costs and patient and family ...
(Date:6/25/2016)... , ... June 25, 2016 , ... As a lifelong ... Cum Laude and his M.D from the David Geffen School of Medicine at UCLA. ... to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Revolutionary ... Oticon , industry leaders in advanced audiology ... of Oticon Opn ™, the world,s first internet ... possibilities for IoT devices.      (Photo: ... introduces a number of ,world firsts,: , ...
(Date:6/23/2016)... The vast majority of dialysis patients currently ... are usually 3 times a week, with treatment times ... time, equipment preparation and wait time.  This regimen can ... patients who are elderly and frail.  Many elderly dialysis ... centers for some duration of time. Residents ...
(Date:6/23/2016)... June 23, 2016  Experian Health, the ... transforming the patient payment and care experience, ... new products and services that will enhance ... cycle offerings. These award-winning solutions will enable ... remain compliant in an ever-changing environment and ...
Breaking Medicine Technology: