Mallinckrodt Hemostat SolutionsMallinckrodt Hemostat Solutions

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Indications

PREVELEAK® Surgical sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Ideal for a variety of surgical sealing challenges

PREVELEAK is proven across a broad range of vascular reconstruction procedures and is effective on1:

Indications

PREVELEAK® Surgical sealant is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Important Risk Information

Contraindications

  • Not for use in patients with known allergies to materials of bovine or shellfish origin.
  • Not for intravascular use.
  • Not for cerebrovascular repair or cerebrospinal leak repair.

Warnings and Precautions

  • Do not use as a substitute for sutures or staples.
  • Avoid exposure to nerves.
  • Do not use in the presence of obvious infection and use with caution in contaminated areas of the body.
  • Do not allow either the uncured or polymerized form to contact circulating blood.
  • PREVELEAK contains a material of animal origin that may be capable of transmitting infectious agents.
  • Repeated use of PREVELEAK in subsequent surgeries has not been studied.
  • Hypersensitivity reactions were not seen using PREVELEAK, but hypersensitivity of BSA has been reported.
  • Avoid contact with skin or other tissue not intended for application.
  • Safety and effectiveness of PREVELEAK in minimally invasive procedures or coronary artery bypass grafting (CABG) have not been established.
  • Do not use blood saving devices when suctioning excess PREVELEAK from the surgical field.
  • PREVELEAK syringe and delivery tips are for single patient use only. Do not resterilize.
  • Do not use if packages have been opened or damaged.
  • Take care not to spill contents of syringe. Avoid tissue contact with material expelled from delivery tip during priming.
  • Avoid pausing more than 10-15 seconds between priming and application to prevent polymerization within the delivery tip.
  • Minimize use in patients with abnormal calcium metabolism (e.g. chronic renal failure, hyperparathyroidism). Polyaldehyde treated tissue can have an enhanced propensity for mineralization.
  • Evidence of cytotoxicity was observed during cell culture-based laboratory assays and is believed to be due to the polyaldehyde component of the product. No evidence of cytotoxicity was observed in animal or clinical studies.

Adverse Reactions

  • Potential adverse effects associated with the use of this class of surgical sealants include application of the sealant to tissue not targeted for the procedure, failure of the sealant to adhere to the tissue, hypersensitivity reaction such as swelling or edema at the application site, possible transmission of infectious agents from materials of animal origin, thrombosis and thromboembolism.
  • Serious adverse events that occurred in clinical studies included death, hypotension, thrombosis/thromboembolism, ischemia, respiratory failure/dysfunction, steal syndrome, and myocardial infarction.

Use In Specific Populations

  • Use of PREVELEAK in pediatric or pregnant patients has not been studied.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the complete Instructions for Use here.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898.

References: 1. Stone WM, Cull DL, Money SR. A randomized prospective multicenter trial of a novel vascular sealant. Ann Vasc Surg. 2012;26(8):1077-1084. 2. Tenaxis Medical, Inc. Summary of safety and effectiveness: ArterX Surgical Sealant. March 1, 2013. 3. Florek H-J, Brunkwall J, Orend K-H, Handley I, Pribble J, Dieck R. Results from a first-in-human trial of a novel vascular sealant. Front Surg. 2015;2:29. doi:10.3389/fsurg.2015.00029. 4. PREVELEAK Surgical sealant [instructions for use]. Hazelwood, MO: Mallinckrodt Hospital Products Inc; 2016.