This is a brief overview of information related to FDA's approval of expanded device indication to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval of expanded device indication.
Product Name: PreveLeak Surgical Sealant
PMA Applicant: Mallinckrodt Pharma IP Trading DAC
Address: Damastown Industrial Estate, Mulhuddart, Dublin 15, Ireland
Approval Date: December 21, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100030S008a.pdf
What is it? PreveLeak Surgical Sealant (PreveLeak) is a medical sealant used to help stop leaks that are formed in tissue, blood vessels or grafts (artificial blood vessels) during the surgical repair of the circulatory system. PreveLeak is a liquid made of two components, purified bovine serum albumim (BSA) and polyaldehyde. The two components are contained in separate barrels of a syringe. Upon mixing these two components, a flexible material is formed.
How does it work? During surgery, a health care provider pushes the plunger of the PreveLeak syringe causing the two components to mix together. The resulting mixture is applied to seal holes and stop bleeding where heart tissue, blood vessels or grafts have been stitched together.
When is it used? PreveLeak is used during surgical procedures involving the blood vessels and tissues around the heart when stitching alone is not enough to stop bleeding.
What will it accomplish? PreveLeak helps to seal leaks around stitches in tissue, blood vessels or grafts to stop bleeding during vascular and open heart surgery. In a clinical study, immediate sealing was achieved in > 95% surgical procedures using PreveLeak.
When should it not be used? PreveLeak should not be used:
- In patients with known allergies to the device materials;
- On the inside of blood vessels; and
- To stop bleeding in the brain or spinal cord.
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available at online.