Preveleak Surgical Sealant
Ready to use out of the package, the speed, strength and flexibility of Preveleak Surgical Sealant stands up to the needs of the most challenging surgeries. Reliably sealing across a broad range of vascular and cardiac procedures, Preveleak mechanically seals areas of leakage and is effective on multiple types of surfaces.
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Overview
Rapid High-Performance Sealing
Preveleak provides rapid sealing with a burst strength in excess of 500 mm Hg*. The strong seal is achieved 60 seconds after application while it gels within 10 to 15 seconds.1,2
*Preclinical data. Results may not correlate to performance in humans.
Features
Mechanism of Action
Preveleak contains equal volumes of purified bovine serum albumin and polyaldehyde, which rapidly cross link with tissue or graft material to form a strong and stable bond. Learn more about how Preveleak works.
Additional Product Benefits
Control for Ease of Use
High viscosity allows for control during application, minimizing the migration of Preveleak surgical sealant from the site of application.
Remains Flexible After Application
Preveleak accommodates the natural movement of vessels with a modulus of elasticity similar to that of a healthy human aorta.1
Minimizes Inflammation and Swelling
Proprietary polyaldehyde cross-linker minimizes the inflammatory response associated with glutaraldehyde-based sealants, and the minimal swelling (<10%) of Preveleak reduces the potential impact on surrounding structures that may be sensitive to compression.3,4
Order & Support
Learn More About Preveleak Surgical Sealant
Ordering and Support Information for Preveleak Surgical Sealant
Get additional ordering, customer, technical, and medical support information for Preveleak Surgical Sealant by contacting Baxter using the links below.
U.S. Catalog
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Other Information
Preveleak Surgical Sealant Indications and Important Risk Information
PREVELEAK Surgical Sealant Indication
Preveleak Surgical Sealant is indicated for use in vascular and cardiac reconstructions (excluding application to arterial and venous grafts used in coronary artery bypass graft surgery) to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage.
PREVELEAK Surgical Sealant 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.
PREVELEAK Surgical Sealant Important Risk Information
Do not use as a substitute for sutures or staples.
Open lumen procedures require protection of the lumen.
Avoid exposure to nerves including the sinoatrial node, and the atrial ventricular nodes.
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 come into contact with circulating blood.
Preveleak Surgical Sealant contains a material of animal origin that may be capable of transmitting infectious agents.
Repeated use of Preveleak Surgical Sealant in subsequent surgeries has not been studied. Hypersensitivity reactions were not seen using Preveleak Surgical Sealant, but hypersensitivity of BSA has been reported.
Avoid tissue contact with material expelled from delivery tip during priming.
Avoid contact with skin or other tissue not intended for application.
Do not use blood saving devices when suctioning excess Preveleak Surgical Sealant from the surgical field.
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).
Safety and effectiveness of Preveleak Surgical Sealant in minimally invasive procedures have not been established.
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.
Do not use Preveleak Surgical Sealant on arterial or venous grafts during coronary artery bypass graft surgery. Preveleak Surgical Sealant may reduce the vasoreactivity of vascular (i.e. internal mammary artery, radial artery or saphenous vein) grafts used in coronary artery bypass graft surgery at the site of application.
PREVELEAK Surgical Sealant Use in Specific Populations
Use of Preveleak Surgical Sealant in pediatric or pregnant patients has not been studied.
Rx only. For safe and proper use of this device, please refer to the full Instructions for Use.
Disclaimers
Rx only. For safe and proper use of product mentioned herein, please refer to the Instructions for Use or Operator Manual.
Baxter, Coseal, PerClot, Preveleak and Recothrom are trademarks of Baxter International Inc. or its subsidiaries. Any other trademarks, product names or brand images are the property of their respective owners.
References
- 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
- Stone WM, Cull DL, Money SR. A randomized prospective multicenter trial of a novel vascular sealant. Ann Vasc Surg. 2012;26(8):1077-1084.
- Tenaxis Medical, Inc. Clinical evaluation report for ArterX Surgical Sealant. April 22, 2013.
- Tenaxis Medical, Inc. Summary of safety and effectiveness: ArterX Surgical Sealant. March 1, 2013.
- Preveleak Surgical Sealant Instructions for Use.