“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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Order in next 8 hours 42 minutes and choose overnight shipping at checkout. 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. 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.
N Duraseal sealant for use in spinal surgeries as long as the company gathers more data. 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
The company looked at patients, with given Duraseal and 56 treated with other methods, according to the FDA.
The Thomson Reuters Trust Principles.
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.
Edward Hanley, a North Carolina orthopedic surgeon.
But surgical sutures cogidien can leave small gaps. Michael Yaszemski, a panel member and Minnesota spinal surgeon. Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than 3 hours, Lurie said. 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 covididn product, which is already FDA-approved for use in cranial surgeries. 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.
Properly closing incisions in brain and spinal surgeries prevents cerebral spinal fluid from leaking, which can cause complications such as infection.
If the FDA approves Duraseal, it should require Covidien to collect more data for at least three months, the panel said. We currently do not have this item in stock, but we can email you as soon as it is available.
Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery.
UPDATE 2-US FDA panel backs new use for Covidien sealant | Reuters