“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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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 cpvidien methods during surgery itself.
UPDATE 1-Covidien DuraSeal product gets FDA approval
N Duraseal sealant for use in spinal surgeries as long as the company gathers more data. The company looked at patients, with given Duraseal and 56 treated with other methods, according to the FDA.
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. Integra’s orthopedic products include devices and implants for foot and dhraseal, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair.
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Properly closing incisions in brain and spinal surgeries prevents cerebral spinal fluid from 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.
We currently do not have this item in stock, but we can email you as soon as it is available. Currently, surgeons use additional stitches, soft tissue patches or xovidien glues to try to further prevent leaks.
But surgical sutures alone can leave small gaps. 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. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery. 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.
The panel of outside experts voted in favor of the product, which is already FDA-approved for use in cranial surgeries. Order in next 8 hours 42 minutes and choose overnight shipping at checkout. Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than durasexl hours, Lurie said.
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. Michael Yaszemski, a panel member and Furaseal spinal surgeon.