Bio-surgical medical device company Lifebond has obtained CE Marking showing its compliance with European standards for it LifeSeal surgical sealant. This extends product access to 32 countries. LifeSeal is the only gastrointestinal (GI) sealant specifically designed and approved for use in GI surgery, and is used in combination with surgical staples to prevent leakage after surgery, a potentially fatal complication which previously affected 15 – 19% of patients. The sealant is applied over colorectal staple lines, forming a flexible protective layer that prevents leaking.
LifeBond has not as yet achieved FDA approval for the product but has acquired ‘Expedited Access Pathway Designation’, a provision that will fast-track approval thanks to high priority processing. This designation is indicated by the FDA when a device shows the potential to address unmet medical needs and may protect patients from serious side effects or life threatening conditions. Other LifeBond products currently in pre-clinical development include LifeMesh, a self-adhesive hernia mesh, surgical adhesives and absorbable hemostats.