Artivion Announces Premarket FDA Approval of PerClot and Transfer of PMA to Baxter

Wednesday, May 24, 2023

Artivion announced that the U.S. Food and Drug Administration (FDA) granted premarket application (PMA) approval of PERCLOT Absorbable Haemostatic System ("PerClot") for use to control bleeding in certain open and laparoscopic surgical procedures.

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. Pursuant to the terms of its previously announced agreements with Baxter, Artivion will transfer ownership of the PMA to Baxter following approval.

The addition of PerClot to Baxter's portfolio further enhances the ability to optimise patient care by addressing a broad range of intraoperative bleeding with both active and passive haemostatic solutions.

Baxter is a perfect partner to commercialise PerClot due to its expertise in blood management and its strong hemostat portfolio, with corresponding customer relationships. The sale of PerClot to Baxter and the recent FDA approval mark the culmination of years of hard work and collaboration across many dedicated teams, in bringing this product to market.