Artivion receives FDA PMA approval of PerClot; transfers designation to Baxter
James Spargo | May 24, 2023 | News story | Medical Communications | Artivion, Baxter International, Cardiology, FDA, PMA, PerClot
US cardiac and vascular surgery company Artivion has announced that the US Food and Drug Administration (FDA) has granted a premarket application (PMA) for PerClot Absorbable Hemostatic System. As Artivion sold PerClot to Baxter International in July 2021, Artivion will transfer ownership of the PMA to it.
Under the 2021 agreement, Artivion will receive $18.75m from a milestone payment, $4.5m of which will go to its formal partner Starch Medical. Artivion will then begin to supply Baxter with PerClot for a minimum of 21 months until manufacturing operations are transferred to Baxter full-time.
With this latest milestone payment, Artivion will have received $44m from Baxter ($10.5m paid to Starch Medical). Pending the achievement of further milestones, Baxter could potentially pay Artivion a further $10.8m.
Pat Mackin, chairman, president and CEO of Artivion, stated: “We are excited to receive FDA approval of PerClot, which represents a significant step forward in optimising patient care by addressing intraoperative bleeding. We continue to see Baxter as the perfect partner to commercialise PerClot due to its expertise in blood management and its strong haemostat 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, and we are proud to have played a part in bringing this product to market.”
Steve Wallace, president of Baxter’s Advanced Surgery business, added: “I would like to thank the team at Artivion for their partnership throughout the FDA review and approval process. The addition of PerClot to Baxter’s portfolio further enhances our ability to optimise patient care by addressing a broad range of intraoperative bleeding with both active and passive haemostatic solutions.”
James Spargo
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