Covidien (Waltham, Massachusetts) had a lot to celebrate over Labor Day weekend as the company learned on Friday and reported on Tuesday morning that it has received FDA approval for its DuraSeal spine sealant. According to the company, this is the first product that has been approved specifically as an adjunct to suturing for intra-operative dural sealing in spine procedures.
"For spine surgery it is a tremendous advancement," Martha Shadan, VP/GM of Bio Surgery at Covidien, told Medical Device Daily. She noted that there are an estimated 1 million spine surgeries done a year in the U.S. and that because this is the first FDA-approved product for intra-operative dural sealing in spine surgeries any products used previously have been used off-label.
"There was a significant unmet need to provide a product that was effective and also FDA-approved," Shadan said.
A neurological devices advisory committee voted for approvability of the device for spinal surgery earlier this year (Medical Device Daily, May 18, 2009).
"For Covidien it's very important to us to be able to address these unmet needs and also address the key concerns or issues that our surgeons are having," Shadan said. She added that the company conducted an "extensive" online survey of surgeons in this sector and that the number one thing they ranked as important was if they knew the product was going to work because they did not want to use multiple products to achieve a watertight seal.
"Our product shows that we achieved an intra-operative seal 100% of the time and we achieved it very quickly and it eliminated the need for them to use other products," Shadan said. "This product for us is really going to address some key concerns."
While DuraSeal spine sealant has been shown in a U.S. pivotal study to deliver an intra-operative watertight seal 100% of the time, according to Covidien, the same study showed that 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, the company noted.
"DuraSeal continues Covidien's dedication to scientific, evidence-based innovation that improves patient outcomes," said Michael Tarnoff, chief medical affairs officer for Surgical Devices at 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 Neill Wright, MD, an associate professor in the departments of Neurological Surgery and Orthopedics at Washington University School of Medicine (St. Louis).
The DuraSeal spine sealant is designed to be a quicker solution than conventional sealing methods for surgeons who are faced with a dural tear, according to Covidien. The company said the 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 (MDD, April 11, 2005) and is on the market for cranial procedures. DuraSeal Cranial and DuraSeal Xact ABS (spine) are also available in Europe and other international markets, the company noted. Covidien says it expects to launch DuraSeal spine sealant in the U.S. in the next few weeks.
According to Covidien, sutured dural tears occur in nearly 10% of all spinal surgeries.
Amanda Pedersen, 229-471-4212;