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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Arista™ AH Absorbable Hemostat
PMA Applicant: Medafor, Inc.
Address: 700 Freeway Boulevard, Suite 800, Minneapolis, Minnesota 55430
Approval Date: September 26, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050038a.pdf
What is it?
Arista ™ AH Absorbable Hemostat (Arista AH) is a product that assists the body in clotting blood. After it has performed its function, the body absorbs it. Arista AH is manufactured from potato starch. Arista AH is intended to assist in clotting when conventional means fail or are impractical.
How does it work?
Arista AH functions as a molecular filter by separating serum from the cellular constituents such as platelets and erythrocytes. Arista AH absorbs much of the water portion of the blood and expands up to 15 times its dry volume. This process acts to concentrate blood solids that are excluded, which then form a gel matrix. The gel matrix slows blood flow and serves to enhance clotting. Absorption of Arista AH by the body begins immediately and usually lasts about a day.
When is it used:
Arista AH is indicated in surgical procedures (except neurological, ophthalmic, and urological) as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
What will it accomplish? Arista AH was shown to be effective in controlling bleeding in general, cardiac and orthopedic surgical procedures. The most common adverse events observed in the treated patients were pain, anemia, nausea and irregular heart rhythm (arrhythmia).
When should it not be used? Arista AH should not be injected into blood vessels or be used in surgical situations where it may enter a blood vessel as it could cause a clot to form in a blood vessel causing serious damage and/or death.
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050038.