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FDA approves Ethicon’s first synthetic internal sealant

 
• By Madeleine Armstrong

The US FDA has granted premarket approval (PMA) for Ethicon’s Omnex surgical sealant, the firm’s first synthetic sealant. The product is designed to stop bleeding during vascular reconstructions by mechanically sealing leaks. Omnex is two to four times as strong as other surgical sealants, Ethicon, a Johnson & Johnson subsidiary, claims. It is also ready to use in less than 30 seconds and is compatible with expanded polytetrafluoroethylene grafts, the Somerville, New Jersey firm added. A 151-patient study has found that Omnex stopped bleeding faster than oxidised regenerated cellulose, another type of sealant (1.99 minutes versus 6.73 minutes, respectively). Omnex is intended for use as an adjunctive sealant and is not recommended in place of sutures, staples, or mechanical closure.

The US FDA has granted premarket approval (PMA) for Ethicon’s Omnex surgical sealant, the firm’s first synthetic sealant. The product is designed to stop bleeding during vascular reconstructions by mechanically sealing leaks. Omnex is two to four times as strong as other surgical sealants, Ethicon, a Johnson & Johnson subsidiary, claims. It is also ready to use in less than 30 seconds and is compatible with expanded polytetrafluoroethylene grafts, the Somerville, New Jersey firm added. A 151-patient study has found that Omnex stopped bleeding faster than oxidised regenerated cellulose, another type of sealant (1.99 minutes versus 6.73 minutes, respectively). Omnex is intended for use as an adjunctive sealant and is not recommended in place of sutures, staples, or mechanical closure.

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