Med Device Monday: Surgical Sealant

Just consider how the old nursery rhyme would have ended if all the King's Horses and all the King's Men had access to surgical glue. That's what we're talking about this week in Medical Device Monday! PREVELEAK® Surgical sealant is used in vascular reconstructions and open heart surgery to mechanically seal areas of leakage. The device consists of a liquid made of two components: purified bovine serum albumim (BSA) and polyaldehyde. The two components are contained in separate barrels of a syringe. During surgery, the two components mix together when a health care provider pushes the plunger of the PREVELEAK® syringe. When these components are mixed, a flexible material is formed. The resulting mixture is applied to seal holes and stop bleeding.

 

 Photo from fda.gov.

Photo from fda.gov.

PREVELEAK® Surgical sealant is commercially marketed by Mallinckrodt Pharmaceuticals. According to the company, PREVELEAK® Surgical sealant, which uses the purified bovine serum albumin, is biocompatible. It gels in 10 to 15 seconds, achieving a strong seal in 60 seconds. It has a burst strength in excess of 500 mm Hg and remains flexible after application. It also has elasticity similar to that of a healthy human aorta, which helps in the natural movement of vessels. In a clinical study, immediate sealing was achieved in > 95% surgical procedures using PREVELEAK®.

Mallinckrodt Pharmaceuticals claims that some of the key safety features of PREVELEAK® Surgical sealant are that it is

1.     Minimally inflammatory: The Polyaldehyde cross-linker minimizes the inflammatory response associated with glutaraldehyde-based sealants.

2.     Minimal swelling: It reduces the potential impact on surrounding anatomic structures that may be sensitive to compression.

3.     Noncytotoxic and bioresorbable.

According to Mallinckrodt Pharmaceuticals, PREVELEAK® Surgical sealant is ideal for a broad range of surfaces and sealing challenges, such dry surfaces and surfaces devoid of free-flowing blood, native vessels as well as synthetic vascular grafts, and vertical surfaces. It can also be used in anticoagulated patients. 

A wound sealant that literally is made to fit the mold is fantastic, and the implications for a product like this aren't difficult to imagine. And it probably would have been a pretty life-saving device for poor Humpty Dumpty as well!

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 Photos from hemostatsolutions.com.

Photos from hemostatsolutions.com.