600 patients enrolled in post-marketing study comparing outcomes
of inguinal hernia repair with self-fixating mesh to gold-standard
repair technique using sutures
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
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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