Artivion Announces FDA PMA Approval of PerClot and Transfer of PMA to Baxter
May 23, 2023 at 01:04 pm
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Artivion, Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket application (PMA) approval of PERCLOT Absorbable Hemostatic System ("PerClot") for use to control bleeding in certain
open and laparoscopic surgical procedures. Artivion sold the PerClot product line to Baxter International Inc. ("Baxter"), in July 2021. Pursuant to the terms of its previously announced agreements with Baxter, Artivion will transfer ownership of the PMA to Baxter following approval. Shipment of PerClot product to Baxter will commence upon receipt of a milestone payment of $18.75 million in cash, $4.5 million of which will be paid to Artivion's former partner Starch Medical, Inc. ("SMI"). Under the terms of its agreements with Baxter, Artivion will supply Baxter with PerClot for a minimum of twenty-one (21) months, until manufacturing operations are transferred in full to Baxter or its designee.
Artivion, Inc. is a medical device company engaged in the manufacturing, processing, and distribution of medical devices and implantable human tissues used in cardiac and vascular surgical procedures for patients with aortic disease, heart valve disease, aortic aneurysms, and dissections. The Company's segments include Medical Devices and Preservation Services. The Medical Devices segment includes sales of aortic stent grafts, surgical sealants, and On-X. The Preservation Services segment includes services for the preservation of cardiac and vascular implantable human tissues. It has four product families: aortic stent grafts, surgical sealants, On-X mechanical heart valves and related surgical products, and implantable cardiac and vascular human tissues. Aortic stent grafts include aortic arch stent grafts, abdominal stent grafts, and synthetic vascular grafts. Surgical sealants include BioGlue Surgical Adhesive products. It also sells or distributes PhotoFix bovine surgical patches.
ARTIVION, INC. 
