DuraSeal™ Spine Sealant Receives FDA Approval

[Justin]

DuraSeal™ Spine Sealant Receives FDA Approval
September 08, 2009 070 AM Eastern Daylight Time
LINK to Original Article

New application provides watertight closure during spinal surgery, offering improvements over common sealing methods

WALTHAM, Mass.--(BUSINESS WIRE)--Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved DuraSeal™ spine sealant for use in the United States. This is the first product that has been approved specifically as an adjunct to suturing for intra-operative dural sealing in spine procedures.

DuraSeal spine sealant has been shown in a U.S. pivotal study to deliver an intra-operative watertight seal 100% of the time(1). In the same study, commonly used sealing methods achieved an intra-operative watertight seal only 64% of the time. The remaining patients were treated with additional products and/or techniques to achieve a watertight seal.

“DuraSeal continues Covidien’s dedication to scientific, evidence-based innovation that improves patient outcomes,” said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien.

“There’s a critical need to resolve cerebrospinal fluid leaks within the OR. We cannot continue with the procedure until we’ve dealt with the leak,” said Dr. Neill Wright, Associate Professor, Neurological & Orthopedic Surgery, Washington University School of Medicine.

The DuraSeal spine sealant is designed to be a quicker solution than conventional sealing methods, for surgeons who are faced with a dural tear:

• The fast-acting, self-contained sealant gives surgeons the only FDA-approved, easy-to-use solution for sutured dural tears, which occur in nearly 10% of all spinal surgeries.
• The DuraSeal spinal sealant only takes two minutes to prepare for use and three seconds to set, so surgeons can quickly complete an intra-operative dural seal.
• The same formulation was approved by the FDA in 2005 and is currently on the market for cranial procedures. Since its approval, more than 210,000 units have been sold worldwide. DuraSeal Cranial and DuraSeal Xact ABS (spine) are also available in Europe and other international markets.
• Covidien expects to launch DuraSeal spine sealant in the next few weeks.

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 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 at Welcome to Covidien to learn more about our business.

(1) DuraSeal™ Spine Sealant instructions for use. REF:20-4300; 1022286.

[Justin]

Covidien Introduces First FDA-Approved Spine Sealant

Fast-acting DuraSeal™ spine sealant provides critical watertight seal during spine surgery
2009 Covidien. All rights reserved.

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 use.”

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 Home.

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 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 Welcome to Covidien to learn more about our business.

1. Jallo J. Cost of CSF leaks after spinal surgery in the USA. Abstract #5. 2009 Congress of NeuroSurgeons.
2. 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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