Device Name: PerClot® Polysaccharide Hemostatic System
Author(s): Brexton Turner, MD and Kate Lak, MD
Artivion, Inc has received FDA approval for the PerClot® Polysaccharide Hemostatic System in May, 2023.
PerClot® Absorbable Hemostatic Powder is a hemostatic agent made of polysaccharide granules. These granules rapidly absorb water to form a matrix that facilitates accumulation of platelets and coagulation factors, aiding in clot formation. PerClot® is delivered using a bellows, which deploys the granules through an applicator tip. The tip can be exchanged for a 20 cm extender tip or a laparoscopic 38 cm tip to be used in minimally invasive settings. Following clot formation, PerClot® granules are broken down and absorbed within 96 hours.
PerClot® has been shown to be substantially equivalent to predicate devices. A prospective, multicenter randomized controlled trial demonstrated comparable rates of hemostasis and duration of clot formation to Arista™ hemostatic powder.
The FDA has approved this device to be used in all surgical procedures (excluding neurological and ophthalmic) to act as an adjunct hemostatic agent for controlling suture line bleeding or other vascular bleeding when conventional measures such as pressure or ligation are impractical. This a topical hemostatic agent and is not for intravascular use, as it could result in embolism and death.
