“DuraSeal continues Covidien’s dedication to scientific, evidence-based innovation that improves patient outcomes,” said Dr. Michael Tarnoff, Chief Medical. Covidien has just announced that FDA gave its approval for the company’s DuraSeal Exact spine sealant, a device designed to help to fix. DuraSeal Spinal Sealant System. (Formerly Covidien DuraSeal). The hydrogel technology of the DuraSeal® Family of products offers sealing solutions .
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Overall, though, panelists said the data was acceptable. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
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Order in next 8 hours 42 minutes and choose overnight shipping at checkout. Integra’s orthopedic products include devices and implants for foot and ankle, hand covifien wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. Edward Hanley, a North Carolina orthopedic surgeon. But surgical sutures alone can leave small gaps.
Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than 3 hours, Lurie said. If the FDA approves Duraseal, it should require Covidien to collect more data for duraeal least three months, the panel said.
Panelists expressed some concern about the product, saying there was no clear difference in fluid leakage 90 days after surgery, even though the data showed Duraseal worked better than alternative methods during surgery itself.
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N Duraseal sealant for use in spinal surgeries as long as the company gathers more data. Accept Credit Cards Online.
Currently, surgeons use additional stitches, soft tissue patches or unapproved glues to try to further prevent leaks. Michael Yaszemski, a panel member and Minnesota spinal surgeon.
The panel of outside experts voted in favor of the product, which is already FDA-approved for use in cranial surgeries.
Properly closing incisions in brain and spinal surgeries prevents cerebral spinal fluid from leaking, which can cause complications such as infection. The company looked at patients, with given Duraseal and 56 treated with other methods, ckvidien to the FDA. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery.
More on Druaseal Integra Lifesciences Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care.