Covidien Announces Patient Enrollment is Complete in Parietex ProGrip(TM) Self-Fixating Mesh Inguinal Hernia Repair Study
NORTH HAVEN, Conn., May 09, 2011 (BUSINESS WIRE) --
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that all 600 patients have been enrolled in its clinical study comparing use of Parietex ProGrip(TM) self-fixating mesh to the gold-standard suture-based Lichtenstein repair method for primary inguinal hernias.
Parietex ProGrip self-fixating mesh has resorbable polylactic acid microgrips that enable surgeons to position and securely place the mesh without the need for sutures. The nine-site, international, prospective randomized trial was designed to compare patient outcomes, including pain, for one year following inguinal hernia repair with each method.
"Completion of enrollment in this study represents a significant milestone for Covidien and we are proud to be leading one of the largest industry-sponsored abdominal wall repair clinical studies to date," said Michael Tarnoff, M.D., Chief Medical Officer, Covidien. "This is a great example of our commitment to generating robust clinical evidence through a well-executed strategy focused on addressing unmet clinical needs and improving patient outcomes."
"Although primary inguinal hernia repair is typically well-tolerated, a significant risk for post-operative pain still exists," noted principal investigator Prof. Andrew N. Kingsnorth, Professor of Surgery at Derriford Hospital, Plymouth, U.K. "Preliminary study results indicate that Parietex ProGrip self-fixating mesh simplifies hernia repair, allowing for faster operating time and less pain in the week following surgery compared to the gold-standard Lichtenstein repair method. We are encouraged by these findings and look forward to reviewing the final study data to confirm these initial promising results."
In March, Prof. Kingsnorth presented interim data on 390 patients in the study during a podium presentation at the 14th Annual Meeting of the American Hernia Society. The interim data demonstrated that patients who received Parietex ProGrip self-fixating mesh during inguinal hernia repair experienced significantly less early pain compared to those whose hernias were repaired using the standard Lichtenstein method.1 Investigators measured pain at discharge and at day seven. Results of the study also show that use of Parietex ProGrip(TM) mesh significantly shortened the surgery duration.1
Prof. Kingsnorth will also present the 390-patient interim analysis at the 33rd International Congress of the European Hernia Society taking place in Ghent, Belgium from May 10 to 13, 2011. Covidien expects the final results of the study to be available in 2012.
About Inguinal Hernia
An estimated 600,000 inguinal hernia repair procedures are performed in the U.S. each year.2 An inguinal hernia is a condition in which intra-abdominal fat or part of the small intestine, also called the small bowel, bulges through an opening or weak area in the lower abdominal muscles. An inguinal hernia appears as a bulge on one or both sides of the groin and can occur any time from infancy to adulthood. Inguinal hernias are much more common in males than females and tend to become larger over time.3
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4 billion, Covidien has 41,000 employees worldwide in more than 65 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
1 Kingsnorth, A., Preliminary Results of a Comparative Randomized Study: Benefit Of Self-Gripping Parietex ProGrip(TM) Mesh In Open Inguinal Hernia Repair, Hernia 2011, the 14th Annual Meeting & Scientific program of the American Hernia Society, March 16, 2011, San Francisco, Calif., Data on file. Study sponsored by Covidien.
2 Malangoni MA, Gagliardi RJ. Hernias. In: Townsend C, Beachamp R, Evers B, Matoox K, eds. Sabiston Textbook of Surgery. 17th ed. Philadelphia: Elsevier Saunders Publishers; 2004: 1199-1218.
3 National Digestive Diseases Information Clearinghouse (NDDIC) Web site. http://digestive.niddk.nih.gov/ddiseases/pubs/inguinalhernia/. Updated December 2008. Accessed March 9, 2011.
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