“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. Michael Yaszemski, a panel member and Minnesota spinal surgeon.
The company looked at patients, with given Duraseal and 56 treated with other methods, according to the FDA. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery. 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. 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.
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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’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.
Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than 3 hours, Lurie said. 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, , Integra DuraSeal Cranial Sealant System 5ml – eSutures
UPDATE 1-Covidien DuraSeal product gets FDA approval
The Thomson Reuters Trust Principles. Currently, surgeons use additional stitches, soft tissue patches or unapproved glues to try to further prevent leaks.
If the FDA approves Duraseal, it should require Covidien to collect more data for at least three months, the panel said. Order in next 8 hours 42 minutes and choose overnight shipping at checkout.
N Duraseal sealant for use in spinal surgeries as long as the company gathers more data. Edward Hanley, a North Carolina orthopedic surgeon.