New product features optimized protection, integration and
handling during laparoscopic ventral hernia repair
NORTH HAVEN, Conn., Jun 02, 2011 (BUSINESS WIRE) --
Covidien (NYSE: COV), a leading global provider of healthcare products,
today announced that the U.S. Food and Drug Administration (FDA) has
granted 510(k) clearance and the European regulatory authorities have
granted the CE Mark to Parietex(TM) Optimized Composite (PCOx) mesh.
Covidien launched PCOx during the recent European Hernia Society meeting
in Ghent, Belgium and the product will be commercially available in the
U.S. and Europe starting in June.
PCOx is the next-generation version of Covidien's Parietex(TM) Composite
(PCO) mesh, engineered to better address surgeon and patient needs in
open and laparoscopic ventral hernia repair. Compared to the original
product, the new product design incorporates a more resistant barrier
and a proprietary textile design with better visibility and increased
"The original PCO is a very trusted product that has been backed by a
robust body of supporting clinical data," said Brian P Jacob, MD FACS of
the Laparoscopic Surgical Center of New York in New York City. "Based on
PCO's characteristics, the new PCOx has been enhanced with a more
resistant barrier and improved visibility through the mesh, creating an
optimal mesh choice for a ventral hernia repair."
The original PCO mesh was introduced in 1999 as the first hernia mesh to
offer a resorbable collagen barrier and has been evaluated in over 45
clinical and pre-clinical studies.
PCOx mesh is three times more resistant than its predecessor, to aid in
insertion and placement. Additionally, the new, proprietary 3-D textile
with x-stitch design is stronger and enables better visibility through
the mesh. Importantly, PCOx has been shown in animals to promote rapid
abdominal wall integration, minimize visceral attachments and facilitate
strong tack fixation.
A version of PCOx with preplaced sutures that reduces the time needed
for traditional suture placement is approved in Europe.
"I'm tremendously proud of our product team for the ingenuity and
innovation they've demonstrated with the development of PCOx," said
Michel Therin, Vice President, Soft Tissue Repair & Biosurgery,
Covidien. "It's an impressive accomplishment to improve upon a trusted
product like PCO mesh by making it stronger and more resistant while
simultaneously preserving the benefits that surgeons expect."
About Ventral Hernia
The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)
estimates that 90,000 ventral hernia repairs are performed each year in
the United States. Ventral hernias typically occur in the abdominal wall
where a previous surgical incision was made. The inner lining of the
abdominal wall bulges through or tears the weakened abdominal wall
muscles and forms a balloon-like sac. This can allow a loop of
intestines or other abdominal contents to push into the sac. If the
abdominal contents get stuck within the sac, they can become trapped or
"incarcerated." This could lead to potentially serious problems that
might require emergency surgery. Ventral hernias can also occur in the
belly button (umbilicus) or any other area of the abdominal wall. SAGES
warns that a hernia does not get better over time, nor will it go away
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.
David T. Young, 203-654-6261
Public Relations Manager
Bruce Farmer, 508-452-4372
Coleman Lannum, CFA, 508-452-4343