Hemostatic gel TISSEEL

neurosurgery

Product overview
TISSEEL (fibrin sealant) is indicated as an adjunct to hemostasis in adult and pediatric patients (greater than 1 month of age) undergoing surgery when conventional surgical techniques (suture, ligature, cautery) are ineffective or impractical. TISSEEL can be used in heparinized patients and is intended for topical application only.

Sealing
As an adjunct to standard surgical techniques, TISSEEL is indicated to prevent leakage from colonic anastomoses following reversal of temporary colostomies. Use as directed in the IFU for anastomotic sealing procedures.

Available configurations and related items

• TISSEEL Kit (Freeze Dried) with DUPLOJECT System - 10 mL (Item #: 1504516): components for reconstitution and delivery; includes 1 DUPLOJECT applicator, joining pieces, application cannula tips, syringes and needles, package insert. Topical use only. Single use. Sterile and non-pyrogenic.
• TISSEEL Kit (Freeze Dried) with DUPLOJECT System - 2 mL (Item #: 1504514): components for reconstitution and delivery. Topical use only. Single use. Sterile and non-pyrogenic.
• TISSEEL Kit (Freeze Dried) with DUPLOJECT System - 4 mL (Item #: 1504515): components for reconstitution and delivery. Topical use only. Single use. Sterile and non-pyrogenic.
• TISSEEL Pre-filled PRIMA Syringe (Frozen), 10 mL (Item #: 1506080): pre-filled frozen PRIMA syringe packaged with 1 DUPLOJECT COMBI Set (2 joining pieces and 4 application cannulas). Also available in 2 mL and 4 mL sizes.
• TISSEEL Pre-filled PRIMA Syringe (Frozen), 2 mL (Item #: 1506078): pre-filled frozen PRIMA syringe packaged with 1 DUPLOJECT COMBI Set. Also available in 4 mL and 10 mL sizes.
• TISSEEL Pre-filled PRIMA Syringe (Frozen), 4 mL (Item #: 1506079): pre-filled frozen PRIMA syringe packaged with 1 DUPLOJECT COMBI Set. Also available in 2 mL and 10 mL sizes.
• Related delivery systems and accessories: DUPLOJECT EASY PREP preparation systems, DUPLOJECT applicators and COMBI sets, DUPLOSPRAY and DUPLOSPRAY MIS applicators (various lengths), DUPLOTIP applicators with snap lock (multiple lengths), DUPLOCATH application catheters and Gasless/Gas Tip applicators for MIS and open procedures. Accessories are single-use sterile products intended for use with TISSEEL.

Specifications / technical details

• Manufacturer / Brand: Baxter
• Commercial name (model): TISSEEL
• Indications: adjunct to hemostasis in adults and pediatric patients (>1 month) when conventional methods are ineffective or impractical; adjunct to prevent leakage from colonic anastomoses after reversal of temporary colostomies
• Effective in: heparinized patients
• Intended use: topical application only; do not inject
• Presentation formats: freeze-dried kits (multiple sizes) and pre-filled frozen PRIMA syringes (2 mL, 4 mL, 10 mL)
• Packaging examples: kits include DUPLOJECT applicator, joining pieces, application cannula tips, syringes, needles, package insert; pre-filled syringes include DUPLOJECT COMBI set
• Sterility: sterile, non-pyrogenic
• Single-use: yes
• Compatible delivery systems/accessories: DUPLOJECT System, DUPLOJECT COMBI Set, DUPLOJECT EASY PREP, DUPLOSPRAY / DUPLOSPRAY MIS applicators, DUPLOTIP applicators, DUPLOCATH catheters, various applicator lengths for MIS and open use