“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 2-US FDA panel backs new use for Covidien sealant
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. Properly closing incisions in brain and spinal surgeries prevents cerebral spinal fluid from leaking, which can cause complications such as infection. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery.
The panel of outside experts voted in favor of the product, which is already FDA-approved for use in covidirn surgeries. Integra’s orthopedic products include durazeal and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair.
UPDATE 1-Covidien DuraSeal product gets FDA approval | Reuters
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
Michael Yaszemski, a panel member and Minnesota spinal surgeon. Order in next 8 duaseal 42 minutes and choose overnight shipping at checkout. The Thomson Reuters Trust Principles.
If the FDA approves Duraseal, it should require Covidien to collect more data for at least three months, the panel said. But surgical sutures alone can leave small gaps. The company looked at patients, with durasral Duraseal and 56 treated with other methods, according to the FDA. Accept Credit Cards Online.
Covidien : News Release : News & Press
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 is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Overall, though, panelists said the data was acceptable.
Currently, surgeons use additional stitches, soft tissue patches or unapproved glues to try to further prevent leaks.
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.