Johnson & Johnson's ($JNJ) Ethicon Biosurgery gained the FDA's blessing for a new device designed to stop otherwise-uncontrollable bleeding during surgical procedures. The regulatory win comes after a tough period of recalls and lawsuits for the larger division.
Regulators approved the Evarrest Fibrin Sealant Patch for use, with manual compression, to stop bleeding during various kinds of noncardiac surgery when sutures, ligature and cauterization don't work. The technology is pretty novel--a biologics coating and a flexible patch that help to clot blood. Meanwhile, the patch becomes part of the clotting process and absorbs into the body over time.
Ethicon Biosurgery President Dan Wildman said in a statement that the technology represents "a significant milestone in advancing patient care."
Ethicon Biosurgery's win is a shot of good news for its parent division, Ethicon, which has faced some problems over the fall. In October, Ethicon was hit with a Class I recall over its Proximate hemorrhoidal staplers because they were too difficult to fire. Regulators worried that the surgical tool could cause problems ranging from bleeding to rectal wall damage, sphincter dysfunction and severe pain. Ethicon faced other recalls this year and last year over various wound-sealing and wound-draining products, and must deal with hundreds of lawsuits concerning its vaginal mesh products.
- read the release
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