“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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Integra’s orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery.
Order in next 8 hours 42 minutes and choose overnight shipping at checkout. Michael Yaszemski, a panel member and Minnesota spinal surgeon.
UPDATE 2-US FDA panel backs new use for Covidien sealant
Edward Hanley, a North Carolina orthopedic surgeon. Properly closing incisions in brain and spinal surgeries ccovidien cerebral spinal fluid covifien leaking, which can cause complications such as infection.
Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. The panel of outside experts voted in favor of the product, which is already FDA-approved for use in cranial surgeries.
UPDATE 1-Covidien DuraSeal product gets FDA approval | Reuters
More on Integra 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. 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. N Duraseal sealant for use in spinal surgeries as long as the company gathers more data. 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.
Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than 3 hours, Covdien said.
Covidien is seeking FDA approval to more widely market Duraseal, a synthetic polymer that is sprayed onto the surgical site to provide a watertight seal, for use in addition to traditional sutures. We currently do not have this item in stock, but we can email you as soon as it is available. If the FDA approves Duraseal, it should require Covidien to collect more data for at least three months, the panel said. The Thomson Reuters Trust Principles.
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