“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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UPDATE 1-Covidien DuraSeal product gets FDA approval
durassal 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. Order in next 8 hours 42 minutes and choose overnight shipping at checkout. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery.
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.
Covidien is seeking FDA approval to more widely market Duraseal, covidiien synthetic polymer that is sprayed onto the surgical site to provide a watertight seal, for use in addition to traditional sutures. Accept Credit Cards Online.
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. We currently do not have this duraseeal in stock, but we can email you as soon as it is available.
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. Integra is a leader in neurosurgery, offering a durassal portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care.
UPDATE 2-US FDA panel backs new use for Covidien sealant
But surgical sutures alone can leave small gaps. N Duraseal sealant for use in spinal surgeries as long as the company gathers more data. Edward Hanley, a North Carolina orthopedic surgeon.
UPDATE 1-Covidien DuraSeal product gets FDA approval | Reuters
Overall, though, panelists said the data was acceptable. Integra LifeSciences, a world leader in medical technology, is dedicated to limiting duuraseal for surgeons, so they can concentrate on providing the best patient care.
The company looked at patients, with given Duraseal and 56 treated with dufaseal methods, according to the FDA. If the FDA approves Duraseal, it should require Covidien to collect more data for at least three months, the panel said.