Covidien Receives FDA Clearance To Market Single-Incision Laparoscopic Surgery (SILS(TM)) Kit

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 May 2008 - 2:00 PDT

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Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, announced that its Surgical Devices business unit has received FDA 510(k) clearance to market the Covidien SILS™ 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™ Procedure Kit is scheduled for commercialization in the summer of 2008, and customized kit solutions are also forthcoming to enable SILS™ procedures for general surgery, urologic, gynecologic and bariatric surgery applications.

"Covidien's introduction of products for SILS™ 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™, 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 NOSCARTM (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 http://www.covidien.com to learn more about our business.

http://www.covidien.com