Status: approved; marketed

Organizations involved:

Baxter International Inc. – Manuf.; R&D; Tech.; Parent; World mark.

Sulzer Spine-Tech – World mark.

Fusion Medical Technologies, Inc. – Former

Cross ref: See the Thrombin-Collagen Gel/old entry (#922) for the prior FloSeal product, in which bovine thrombin was used, rather than human plasma-derived Thrombin. See also the Thrombin Products entry (#919), the other Thrombin product entries, and the Fibrin Sealant Products entry (#735). See also the Thrombin, conc. entry (above), used in the manufacture of this product.

Description: FloSeal Matrix Hemostatic Sealant (and the equivalent Proceed Hemostatic Sealant) is an adsorbable hemostatic (halts bleeding) product combining topical lyophilized (freeze-dried) human Plasma-derived Thrombin and a granular collagen or cross-linked Gelatin Matrix component. [FDA uses the term cross-linked gelatin; Baxter uses the term collagen]. See entry #922 for further information.

Nomenclature: Thrombin-Collagen gel [BIO]; Gelatin Matrix Hemostatic Sealant [FDA]; FloSeal Matrix Hemostatic Sealant [TR]; Proceed Hemostatic Sealant [TR]; FloSeal [SY]

Companies.: FloSeal, containing bovine thrombin, was developed and originally manufactured and marketed by Fusion Medical Technologies Inc. In May 2002, Baxter acquired Fusion Medical Technologies. The Baxter BioSurgery division of Baxter now markets FloSeal in the U.S. and internationally.

Proceed Hemostatic Sealant, essentially the same product, is marketed for spinal applications by Sulzer Spine-Tech.

FDA class: Medical device; PMA

Approvals: Date = 20050329; PMA (P990001/S017)

Indications: [full text of the "Indications” section of product insert/labeling]

FloSeal Matrix is indicated in surgical procedures (other than neurological, ophthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical

Status: This FloSeal product replaced comparable product containing bovine thrombin (see entry #808).

Market: Average Wholesale Price (AWP) not available (product not in 2007, 2005 or 2004 Red Book).