Excerpt from Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure 2013-2018”.
Biologically active sealants typically contain various formulations of fibrin and/or thrombin, either of human or animal origin, which mimic or facilitate the final stages of the coagulation cascade. The most common consist of a liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use, both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components just prior to delivery to the wound. Because of the laborious preparation process, these products are not easy to use. However, manufacturers have been developing some new formulations designed to make the process more user friendly.
Selected Biologically Active Sealants, Glues, and Hemostats
|Asahi Kasei Medical||CryoSeal FS System||Fibrin sealant system comprising an automated device and sterile blood processing disposables that enable autologous fibrin sealant to be prepared from a patient’s own blood plasma in about an hour. Approved in the US for liver resection surgery and CE marked in Europe. Also sold in Japan and other Asian countries.|
|Baxter||Artiss||Fibrin sealant spray|
|Tisseel||Biodegradable fibrin sealant made of human fibrinogen and human thrombin. For oozing and diffuse bleeding.|
|FloSeal||Hemostatic bioresorbable sealant/glue containing human thrombin and bovine-derived, glutaraldehyde-crosslinked proprietary gelatin matrix. For moderate to severe bleeding.|
|GelFoam Plus||Hemostatic sponge comprising Pfizer’s Gelfoam hemostatic sponge, made of porcine skin and gelatin, packaged with human plasma-derived thrombin powder.|
|Behring/Nycomed||TachoComb (sold OUS only). Manufactured by Nycomed||Fleece-type collagen hemostat coated with fibrin glue components.|
|Bristol-Myers Squibb/ZymoGenetics (sold by The Medicines Company in the US and Canada)||Recothrom||First recombinant, plasma-free thrombin hemostat; approved in US in 2008.|
|CSL Behring||Beriplast P/Beriplast P Combi-Set (sold OUS only)||Freeze dried fibrin sealant. Comprised of human fibrinogen-factor XIII and thrombin in aprotinin and calcium chloride solution.|
|Haemocomplettan P, RiaSTAP||Freeze-dried human fibrinogen concentrate.
Haemocomplettan is sold in US and RiaSTAP is on the market in Europe.
|J&J/Ethicon||Evicel||Evicel is a new formulation of the previously available fibrin sealant Quixil (EU)/Crosseal (US). Does not contain the antifibrinolytic agent tranexamic acid, which is potentially neurotoxic, nor does it contain synthetic or bovine aprotinin, which reduces potential for hypersensitivity reactions.|
|Evarrest||Absorbable fibrin sealant patch comprised of flexible matrix of oxidized, regenerated cellulose backing under a layer of polyglactin 910 non-woven fibers and coated on one side with human fibrinogen and thrombin. FDA approved December 2012.|
|BIOSEAL Fibrin Sealant||Low-cost porcine-derived surgical sealant manufactured in China by J&J company Bioseal Biotechnology and targeted to emerging markets.|
|Evithrom||Human thrombin for topical use as hemostat. Made of pooled human blood.|
|Pfizer/King Pharmaceuticals||Thrombin JMI||Bovine-derived topical thrombin hemostat.|
|Stryker/Orthovita||Vitagel Surgical||Bovine collagen and thrombin hemostat.|
|Takeda/Nycomed||TachoSil||Absorbable surgical patch made of collagen sponge matrix combined with human fibrinogen and thrombin. FDA approved as adjunct to hemostasis in cardiovascular surgery. This is the latest version of TachoComb (see above).|
|Teijin Pharma Ltd/Teijin Group (Tokyo, Japan)||KTF-374||Company is working with Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN) to develop a sheet-type surgical fibrin sealant. Product combines KAKETSUKEN’s recombinant thrombin and fibrinogen technology with Teijin’s high-performance fiber technology to create the world’s first recombinant fibrin sealant on a bioabsorbable, flexible, nonwoven electrospun fiber sheet.|
|The Medicines Company (TMC)||Raplixa (formerly Fibrocaps)||Sprayable dry-powder formulation of fibrinogen and thrombin to aid in hemostasis during surgery to control mild or moderate bleeding.|
|In development: Fibropad patch||FDA accepted company’s BLA application for Fibrocaps in April 2014 and set an action date (PDUFA) of January 31, 2015. In November 2013, the European Medicines Agency agreed to review the firm’s EU marketing authorization application. Company anticipates US and European launch in early to mid-2015.|
|Vascular Solutions||D-Stat Flowable||Thick, but flowable, thrombin-based mixture to prevent bleeding in the subcutaneous pectoral pockets created during pacemaker and ICD implantations.|
Note: Status of products detailed in Report #S192.
Source: MedMarket Diligence, LLC