“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 .
If the FDA approves Duraseal, it should require Covidien to collect more data for at duuraseal three months, the panel said. 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.
Results also showed Duraseal reduced surgical times by just about 3 minutes for procedures that generally last more than 3 hours, Lurie said.
Integra, , Integra DuraSeal Cranial Sealant System 5ml – eSutures
The panel of outside experts voted in favor of the product, which is already FDA-approved for use in cranial surgeries. Overall, though, panelists said the data was acceptable. 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. Accept Credit Cards Online. 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.
Currently, surgeons use additional stitches, soft tissue patches or unapproved glues to try to further prevent leaks. 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.
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. Properly closing incisions in brain and spinal surgeries prevents cerebral spinal fluid from leaking, which can cause complications such as infection. 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.
N Duraseal sealant for use in spinal surgeries as long as the company gathers more data.
The Thomson Reuters Trust Principles. 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.