†Preclinical data. Results may not correlate to performance in humans.
Clinical Study Results: Efficacy in Aortic Reconstruction With Dacron Grafts5
Results showed that compared to GELFOAM® Absorbable Sponge with thrombin, COSEAL Surgical Sealant provided a significantly greater proportion of bleeding suture line sites that:
- Achieved immediate sealing following establishment of blood flow
- Achieved complete anastomotic sealing within 5 minutes
- A prospective, randomized, controlled, multicenter study with 54 adults with nonruptured aortic aneurysms (37 COSEAL, 17 Control)
- Treatment was applied after confirmation of anastomotic suture hole bleeding
- COSEAL Surgical Sealant (n = 37/59 sites)
- GELFOAM® with thrombin (n = 17/27 sites)
- Dacron grafts were used for both proximal and distal aorta-to-graft anastomoses
Clinical Study Results: Efficacy in PTFE Grafting6
Results on the efficacy of COSEAL Surgical Sealant and GELFOAM® Absorbable Sponge with thrombin in patients undergoing PTFE grafting showed that COSEAL Surgical Sealant provided:
- Similar anastomotic sealing to GELFOAM® with thrombin
- Complete sealing significantly more rapidly than GELFOAM® with thrombin
- No adverse events related to the use of COSEAL Surgical Sealant
- Prospective, randomized, controlled, multicenter study at 9 centers
- 148 adults undergoing PTFE grafting for infrainguinal revascularization and creation of dialysis access shunts
- Treatment of anastomotic suture hole bleeding
- COSEAL Surgical Sealant (without manual compression)
- GELFOAM® with thrombin
- Primary endpoints
- Complete anastomotic sealing ≤10 minutes
- Number of patients achieving immediate sealing
- Time required to fully inhibit suture hole bleeding
COSEAL Surgical Sealant Indication
COSEAL is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
COSEAL Important Risk Information
- COSEAL is not to be used in place of sutures, staples or mechanical closure.
- Do not apply COSEAL over any devices or object that will need to be removed. COSEAL must not be used as a mechanism of adherence, even temporarily, for any object.
For more Information, please see Detailed Important Risk Information and Instructions For Use.
- COSEAL Surgical Sealant Instructions for Use, Hayward, CA: Baxter Healthcare Corporation. March 2009.
- Hill A, Estridge TD, Maroney M, et al. Treatment of suture line bleeding with a novel synthetic surgical sealant in a canine iliac PTFE graft model. J Biomed. 2001;58: 308-312.
- Wallace DG, Cruise GM, Rhee WM, et al. A tissue sealant based on reactive multifunctional polyethylene glycol. J Biomed. 2001;58: 545-555.
- Natour E, Suedkamp M, Dapunt OE. Assessment on the effect of blood loss and transfusion requirements when adding a polyethylene glycol sealant to the anastomotic closure of aortic procedures: a case-control analysis of 102 patients undergoing Bentall procedures. J Cardiothorac Surg. 2012;7:105.
- Hagberg RC, Safi HJ, Sabik J, et al. Improved intraoperative management of anastomotic bleeding during aortic reconstruction: Results of a randomized controlled trial. Am Surg. 2004;70: 307-311.
- Glickman M, Gheissari A, Money S, et al. A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than Gelfoam/Thrombin. Arch Surg. 2002;137: 326-331.
- Azadani AN, Matthews PB, Ge L, et al. Mechanical properties of surgical glues used in aortic root replacement. Ann Thorac Surg. 2009;87(4):1154-1160.
- Ferraris VA, Brown JR, Despotis GJ, et al. 2011 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Ann Thorac Surg. 2011;91:944-982.