Covidien Receives FDA Clearance to Market Single-Incision Laparoscopic Surgery (SILS(TM))...
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Covidien Receives FDA Clearance to Market Single-Incision Laparoscopic Surgery (SILS(TM)) Kit
New Kit Facilitates Laparoscopic Surgery
NORTH HAVEN, Conn.--(Business Wire)--
Covidien (NYSE: COV, BSX: COV), a leading global provider of
healthcare products, today announced that its Surgical Devices
business unit has received FDA 510(k) clearance to market the Covidien
SILS(TM) Procedure Kit, indicated for Single-Incision Laparoscopic
Surgery and other advanced laparoscopic procedures.
The devices in the kit can be used by surgeons to conveniently
perform laparoscopic procedures through a single skin incision located
within the patient's umbilicus, or belly button. The kit features
several advanced articulating instruments and access ports, which
enable improved access to the surgical site and maneuverability for
tissue dissection and retraction. The Covidien SILS(TM) Procedure Kit
is scheduled for commercialization in the summer of 2008, and
customized kit solutions are also forthcoming to enable SILS(TM)
procedures for general surgery, urologic, gynecologic and bariatric
surgery applications.
"Covidien's introduction of products for SILS(TM) is an important
step toward our ultimate goal of enabling incision-less surgery that
will improve patient outcomes," said Scott Flora, President, Surgical
Devices, Covidien. "We led the first surgical revolution with
multi-port laparoscopic surgery, and we are innovators once again with
SILS(TM), which offers surgeons an immediate advancement in patient
care by minimizing scarring and pain," he added.
Covidien is actively working with surgeons around the world to
develop even less invasive approaches for surgery, including Natural
Orifice Transluminal Endoscopic Surgery (NOTES) performed through the
body's natural orifices. In 2007, the Company established the Covidien
NOTES Research Fund in conjunction with NOSCAR(TM) (Natural Orifice
Surgery Consortium for Assessment and Research) to support clinical
research in key technological areas of this new form of surgery,
including peritoneal access, suturing and anastomotic devices.
ABOUT COVIDIEN
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 four segments: Medical Devices,
Imaging Solutions, Pharmaceutical Products and Medical Supplies. With
2007 revenue of nearly $9 billion, Covidien has more than 42,000
employees worldwide in 57 countries, and its products are sold in over
130 countries. Please visit www.covidien.com to learn more about our
business.
Covidien
Joel Weinberg, 203-492-5576
Manager - Media Relations
Surgical Devices
joel.weinberg@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Bruce Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com
or
Wayde McMillan, 508-452-4387
Director
Investor Relations
wayde.mcmillan@covidien.com
Copyright Business Wire 2008
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