Interim results of a nine-site prospective clinical study
presented at Hernia Repair 2011
NORTH HAVEN, Conn., Mar 21, 2011 (BUSINESS WIRE) --
Covidien (NYSE: COV), a leading global provider of healthcare products,
announced interim results of its multicenter, international, prospective
study comparing use of its Parietex ProGrip(TM) self-fixating mesh to the
traditional Lichtenstein repair, the gold-standard technique for
inguinal hernia repair. The data were presented during a podium
presentation at Hernia Repair 2011, the 14th Annual Meeting &
Scientific Program of the American Hernia Society.
The interim data demonstrate 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 mesh significantly
shortened the surgery duration.1
"By eliminating the need for abdominal wall sutures, 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," said principal
investigator Prof. Andrew N. Kingsnorth, Professor of Surgery at
Derriford Hospital, Plymouth, U.K. "We look forward to seeing additional
data, including the final results of the study, to confirm these
At the time of this interim data analysis, 390 patients had been
randomized and followed for three months at nine international centers.
Ultimately, 600 patients will be enrolled into the study and followed
for a year.
To perform the Lichtenstein method, surgeons suture a mesh patch over
the hernial opening to reduce weakness in the abdominal wall. This
technique is associated with a 4% hernia recurrence rate after five years2,
and 6% of patients continue to experience severe chronic pain three
years after the procedure.3 Parietex ProGrip self-fixating
mesh has small, absorbable, polylactic acid grips on one side to secure
immediate fixation to the abdominal wall, eliminating the need to suture
the mesh into place.
The study protocol allowed surgeons to position the Parietex ProGrip
self-fixating mesh with one stitch of absorbable suture. Of the 193
patients who received Parietex ProGrip self-fixating mesh, 69% had it
placed without a suture. When compared to the baseline, the pain was
significantly reduced at one and three months for the patients without
fixation compared to patients receiving the single stitch.
"These results underscore Covidien's commitment to providing clinicians
with the evidence they need to confidently adopt our products to improve
patient outcomes," said Michael Tarnoff, M.D., Chief Medical Officer,
Covidien. "We always strive to deliver innovative products that respond
to unmet needs for both surgeons and patients."
Separately at the meeting, surgeons presented new data supporting the
Parietex ProGrip self-fixating mesh in incisional hernia procedures.
AbsorbaTack(TM) absorbable mesh fixation system in laparoscopic inguinal
Permacol(TM) surgical implant in open incisional hernia repair.
Covidien highlighted products at Hernia Repair 2011 include:
Optimized Composite Mesh (PCO Optimized) -- 510(k) clearance
pending. Designed to deliver optimal strength, optimal handling and
Fixation Device--A sterile, single-use device
designed for fixation of prosthetic material, such as hernia mesh, to
soft tissues in laparoscopic abdominal wall surgeries and open hernia
repair. The tack is constructed of an absorbable synthetic polyester
copolymer derived from lactic and glycolic acid.
ProGrip Self-fixating Mesh -- Designed for ease of use,
resorbable polylactic acid (PLA) microgrips enable surgeons to position
and securely place the mesh in under 60 seconds without the use of
additional fixation. Tension is evenly distributed for patient comfort.
Surgical Implant -- The processing of this porcine dermal
collagen implant gently removes cells, cell debris, DNA and RNA without
damaging the 3D collagen matrix. The resulting acellular collagen matrix
is then cross-linked for enhanced durability throughout the wound
healing process in complex abdominal wall and hernia repairs.
About Inguinal Hernia
An estimated 600,000 inguinal hernia repair procedures are performed in
the U.S. each year.4 An inguinal hernia is a condition in
which intra-abdominal fat or part of the small intestine, also called
the small bowel, bulges through a weak area in the lower abdominal
muscles. This type of hernia is designated inguinal because fat tissue
or part of the intestine protrudes through a weak area at the inguinal
ring at the opening to the inguinal canal, a passage in the front
abdominal wall. 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.5
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 approximately
42,000 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 Bisgaard T, Bay-Nielsen M, Christensen IJ, Kehlet H. Risk
of recurrence 5 years or more after primary Lichtenstein mesh and
sutured inguinal hernia repair, Br J Surg. 2007;94(8):
3 Fränneby U, Sandblom G, Nordin P, Nyrén O, Gunnarsson U. Risk
factors for long-term pain after hernia surgery, Ann Surg.
4 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.
5 National Digestive Diseases Information Clearinghouse
(NDDIC) Web site. http://digestive.niddk.nih.gov/ddiseases/pubs/inguinalhernia/.
Updated December 2008. Accessed March 9, 2011.
David T. Young, 203-654-6261
Public Relations Manager
Bruce Farmer, 508-452-4372
Coleman Lannum, CFA, 508-452-4343
Todd Carpenter, 508-452-4363