PerClot Polysaccharide Hemostatic System - P210036
This is a brief overview of information related to FDA’s approval 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.
Product Name: PerClot Polysaccharide Hemostatic System
PMA Applicant: Artivion, Inc. (formerly CryoLife, Inc.)
Address: 1655 Roberts Blvd. NW, Kennesaw GA 30144
Approval Date: May 19, 2023
Approval Letter: Approval Order
What is it?
PerClot Absorbable Hemostatic Powder (PerClot) is a powder made of absorbable granules of a substance called a polysaccharide. It is used to stop bleeding and promote blood clotting during surgery.
The PerClot System includes the following components:
- PerClot (granules/powder)
- PerClot Delivery System
- PerClot Accessory Tips (optional)
How does it work?
PerClot granules have a molecular structure that rapidly absorbs water, forming a sticky gel. The gel creates a physical barrier to stop bleeding. The barrier helps platelets, red blood cells, and clotting proteins (coagulation proteins such as thrombin and fibrinogen) accumulate and form a natural clot.
After the clot has formed, PerClot granules are broken down and absorbed by the body. In preclinical studies, absorption occurs within 96 hours but depends on the amount that is applied and where it was used.
When is it used?
PerClot Absorbable Hemostatic Powder is indicated in surgical procedures (except neurological and ophthalmic) to help control bleeding when pressure, tying of blood vessels (ligature), or other typical methods do not work or are not practical.
What will it accomplish?
During surgery (general, urologic, or cardiac), PerClot demonstrated the ability to stop bleeding at a rate similar to a control. The effectiveness of PerClot and the control were measured using a validated 6-point scale.
Additional supplemental clinical evidence, clinical studies from outside the United States, supporting clinical literature, and a history of safe treatment in commercial use outside the U.S. support the safety and effectiveness of PerClot for its intended use. The safety profile of PerClot was found to be similar to the control in terms of rates and types of adverse events and serious adverse events.
When should it not be used?
PerClot should not be injected into arteries or veins as blockages may form (embolization) that can lead to serious injury or death.
Additional information (including warnings, precautions, and adverse events):