Covidien Announces DuraSeal™ Exact Spine Sealant Receives FDA Approval

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that its DuraSeal™ Exact spine sealant has been approved by the U.S. Food and Drug Administration (FDA). DuraSeal Exact spine sealant is a new, low-swell formulation of dural sealant designed as an adjunct to suturing to repair the dura during spine surgery. The dura mater, or dura, encompasses the three layers of the meninges surrounding the spinal cord that protect and hold cerebrospinal fluid.

"The approval of DuraSeal Exact spine sealant demonstrates that Covidien truly understands the needs of the spine surgeon. This low-swell product enables us to provide the best possible care for our patients by facilitating our efforts to seal the dura with minimal obstruction of our view of the surgical site,” said Neill M. Wright, M.D., Associate Professor in Neurological and Orthopaedic Surgery, Department of Neurological Surgery at Washington University School of Medicine, St. Louis. "Because cerebrospinal fluid leaks must be dealt with immediately, it is clinically advantageous to have a product at a surgeon’s disposal that can consistently and reliably form a complete seal every time.”

DuraSeal Exact spine sealant was shown in clinical trials to deliver an intra-operative watertight seal of the dura, in the per protocol population, 100% of the time.¹ In contrast, the control group, treated with standard methods of dural closure including fibrin sealants, achieved an intra-operative watertight seal only 79% of the time.¹

DuraSeal Exact will be launched this quarter and follows Covidien’s 2009 launch of DuraSeal spine sealant, the only dural spine sealant approved by the FDA. The compound is a 100% synthetic absorbable hydrogel that provides excellent tissue adherence and a consistent watertight seal around the dura.

DuraSeal Exact spine sealant is formulated with a lower molecular weight than its predecessor, resulting in decreased post-application swelling and allowing surgeons to confidently use the product in spinal surgery.¹ The product is absorbed over a 9-12 week time period, demonstrating a much longer persistence than fibrin glues.^1,2

"This new DuraSeal Exact spine sealant formulation reinforces Covidien’s commitment to working with the surgeons and nurses who use our products to continuously make improvements to meet their needs in the operating room,” said Michael Tarnoff, M.D., Chief Medical Officer, Covidien. "Using evidence-based innovation that improves patient outcomes, the new formulation was developed to provide surgeons with a low-swell version of a product they know and trust to enhance sealing of the dura in spinal surgery.”

The DuraSeal Exact spine sealant is designed to be a quicker solution than conventional sealing methods for surgeons who are faced with a sutured dural tear, occurring in approximately 10% of all spinal surgeries.³ The self-contained hydrogel takes only two minutes to prepare for use and three seconds or less to set, so surgeons can quickly complete an intra-operative seal. In addition, DuraSeal Exact spine sealant’s distinctive blue colorant provides excellent visualization to the surgeon to immediately confirm coverage and thickness of the seal, on the target application site.

DuraSeal dural sealant was approved by the FDA in 2005 for use during brain surgery. DuraSeal spinal sealant was originally approved by FDA in September 2009. DuraSeal sealants are also available in Europe and other international markets.

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 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 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

1. DuraSeal™ Exact Spine Sealant instructions for use. REF: 1040283. Covidien, Mansfield, MA.

2. Sapala JA, Wood MH, Schuhknecht MP. Anastomotic leak prophylaxis using a vapor-heated fibrin sealant: report on 738 gastric bypass patients. Obes Surg 2004; 14:35-42.

3. Shaw J, Incidental durotomy/dural tear. Presentation to Centers for Disease Control and Prevention ICD-9-CM Coordination and Maintenance Committee, March 19-20, 2008.