“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.

Coviiden currently do not have this item in stock, but we can email you as soon as it is available. Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than 3 hours, Lurie said. But surgical sutures alone can leave small gaps.

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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 company looked at patients, with given Duraseal and 56 treated with other methods, according to the FDA.

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. N Duraseal sealant for use in spinal surgeries as long as the company gathers more data.

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If the Ckvidien approves Duraseal, it should require Covidien to collect more data for at least three months, the panel 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.

COVIDIEN: 20-2050-1

Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery. Michael Yaszemski, a panel member and Minnesota spinal surgeon.

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The panel of outside experts voted in favor of the product, which is already FDA-approved covvidien use in cranial surgeries. We use cookies for Google Analytics and session tracking for your secure shopping experience. The Thomson Reuters Trust Principles. Properly closing incisions in brain and spinal surgeries prevents cerebral spinal fluid from leaking, which can cause complications such as infection.

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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.

Currently, surgeons use additional stitches, soft tissue patches or unapproved glues to try to further prevent leaks.

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. Accept Credit Cards Online.

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Edward Hanley, a North Carolina orthopedic surgeon. 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.

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 duraeal.

Last modified: November 10, 2020