Interim results of a 10-site prospective clinical study presented
at SAGES 2011
NORTH HAVEN, Conn., Apr 05, 2011 (BUSINESS WIRE) --
Covidien (NYSE: COV), a leading global provider of healthcare products,
today announced interim results of its multicenter, international,
prospective SILS(TM) Port laparoscopic cholecystectomy (removal of the gall
bladder) post-market clinical study.
"The interim results of this study show that single-incision gall
bladder surgery appears to be as safe and effective as standard
multi-port cholecystectomy. In addition, patients may view the cosmetic
results as superior when compared to the traditional four-port
laparoscopic approach," said primary investigator Jeffrey M. Marks,
M.D., FACS. "This prospective study is designed to confirm that a
single-incision procedure is safe and to determine whether the perceived
benefits will hold true across a wider population of patients. If the
final results remain in line with this interim analysis, I expect a
growing number of patients concerned about the appearance of their
abdomens to seek out surgeons who offer them the choice of a major
operation with fewer incisions."
Dr. Marks is Associate Professor in the Department of Surgery and
Director of Surgical Endoscopy at University Hospitals at Case Medical
Center in Cleveland, OH. His team presented the interim topline results
of the study during a podium presentation at SAGES 2011, the annual
meeting of the Society of American Gastrointestinal and Endoscopic
Surgeons, which took place in San Antonio, TX from March 30 to April 2.
The prospective, randomized, controlled trial was designed to assess the
feasibility and safety of performing gall bladder surgery via a single
incision through the belly button with the aid of Covidien's SILS Port.
The study protocol allows participating surgeons to objectively document
the scientific merit and the perceived advantages using the SILS Port
through a single incision over a traditional laparoscopic technique
(four incisions). The participating surgeons will monitor patients in
the study for a year after the procedure to track their pain, quality of
life and the cosmetic appearance of their abdomens.
All 200 patients have now been enrolled in the study; this data analysis
includes preliminary results of 189 patients.
The 111 patients who underwent gall bladder surgery with the single
incision approach reported significantly better cosmetic outcomes up to
three months after their procedures, compared to the group whose
surgeons used four laparoscopic ports. The pain scores between the two
groups were within one point of each other on a 10 point visual analog
scale rendering pain as clinically similar between the two groups.
Surgeons, on average, took 12 minutes longer to perform the gall bladder
surgery with the single-port approach (57 vs. 45 min., p<0.0001), but
there was no difference in blood loss during the operation.
"Covidien is dedicated to collaborating with the surgical community to
generate evidence that supports the use of its innovative products to
help patients achieve better outcomes," said Michael Tarnoff, M.D.,
Chief Medical Officer, Covidien. "This is one of the largest prospective
studies of the SILS technique conducted to date in the U.S. Covidien's
surgical devices business is firmly committed to bring products like the
SILS Port to market that aim to reduce the surgical footprint."
the Covidien SILS Port
Covidien's SILS Port is an advanced surgical product designed to allow
laparoscopic surgery through a single incision. This product is designed
to give surgeons the ability to use multiple instruments with maximal
maneuverability through a single incision in the patient's umbilicus
(belly button). The SILS Port leaves a hidden scar when used in the
umbilicus and may minimize postoperative pain when compared to
traditional open procedures.
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.
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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