Johnson & Johnson's ($JNJ) Ethicon division received clearance from the FDA for an expanded indication of its Evarrest patch, which can now be used to help control bleeding during adult liver surgery.
The Evarrest patch got its 510(k) clearance in 2012 for use in stopping unexpected and uncontrollable bleeding during noncardiac surgery. The patch is bioabsorbable, and uses human thrombin and fibrinogen proteins that aid clotting.
For its new indication, the company says it will help stop difficult-to-control bleeding in areas of the body prone to bleed during liver surgery as well as be a cost-saver because it reduces the need for transfusions and additional treatments.
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| Krishna Athota |
"This expanded indication for Evarrest reinforces this innovation's potential to make problematic bleeding situations routine, and could result in a paradigm shift in the treatment of bleeding during surgery," Krishna Athota, a trauma and critical care surgeon at the University of Cincinnati College of Medicine, said in a prepared statement.
In a clinical study cited by the company, the device was more than 94% effective in controlling bleeding in all patient types and surgical situations when compared to the current standard of care, which is less than 53% effective.
The J&J unit weathered regulatory woes in 2012, struggling with recalls of products that included its Proximate hemorrhoidal staplers and other wound-draining products, but has appeared to bounce back. Last year, the company won FDA clearance for its Enseal G2 device. The G2 was the first articulating advanced energy device designed to allow surgeons to take a perpendicular approach to seal vessels.
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