Fast-acting DuraSeal™ spine sealant provides critical watertight seal
during spine surgery
NORTH HAVEN, Conn.--(BUSINESS WIRE)--Nov. 11, 2009--
Covidien (NYSE: COV), a leading global provider of healthcare products,
today announced the launch of DuraSeal™ spine sealant, the first product
approved by the U.S. Food and Drug Administration (FDA) for
intra-operative sealing of the dural membrane during spine procedures.
Nearly 1.5 million spine surgeries are performed in the U.S. every year,
with an estimated 10% of these surgeries requiring dural repair and
sealing. Tears in the dura ─ the outermost membrane covering the brain
and the spinal cord ─ can result in cerebral spinal fluid (CSF) leaks
after surgery, leading to possible medical complications and extended
hospital stays. One recent study found that CSF leaks after spinal
surgery are estimated to cost an average of $6,479 in additional
expense, mainly due to longer hospital and intensive care unit stays.¹
In a clinical study of more than 150 patients, DuraSeal spine sealant
was shown to be superior at achieving an intra-operative watertight
seal, compared with the control group, which consisted of conventional
methods of dural closure such as sutures or fibrin sealants. DuraSeal
spine sealant achieved an intra-operative watertight seal 100% of the
time, compared with 64% of the time by the control group. The safety
results between the two groups were similar, given the patients’ medical
conditions and the nature of the complex spinal procedures performed.²
The new sealant is a 100% synthetic hydrogel that provides excellent
tissue adherence, is absorbed by the body and is easy to apply. Stored
at room temperature, DuraSeal spine sealant takes only two minutes to
prepare and three seconds to set, which enables surgeons to achieve an
intra-operative dural seal quickly.
“DuraSeal is a great example of how we develop solutions at Covidien,”
said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical
Devices, Covidien. “We observe the challenges that surgeons face in the
operating room and work with the medical community to come up with
innovative products that may optimize patient outcomes, can improve
healthcare economics and are intuitive for surgeons and their teams to
The DuraSeal spine sealant system was introduced today at the
North American Spine Society Annual Meeting in San Francisco and last
month at the Congress of Neurological Surgeons in New Orleans. For
further information, please visit www.durasealspine.com.
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 2008 revenue of $10 billion, Covidien has more than
41,000 employees worldwide in 59 countries, and its products are sold in
over 140 countries. Please visit www.covidien.com
to learn more about our business.
Jallo J. Cost of CSF leaks after spinal surgery in the USA. Abstract
#5. 2009 Congress of NeuroSurgeons.
Wright NM. DuraSeal™ spine sealant as an adjunct to standard dural
repair: results of a prospective multicenter, randomized study.
Abstract #928, 2009 Congress of NeuroSurgeons.
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David T. Young, 203-492-6333
Public Relations Manager
Lannum, CFA, 508-452-4343