The Duett closure device: concept and experimental results.
Purpose of this paper is to investigate the hemostatic capabilities of a novel vascular sealing device consisting of a balloon catheter and procoagulant. Vascular sheaths were placed percutaneously in the femoral arteries of dogs. The sealing device was evaluated using the balloon catheter alone in 6 femoral arteries and with the addition of a procoagulant in 21 femoral arteries. The balloon catheter alone was successfully deployed in 6 of 6 femoral arteries achieving immediate hemostasis. In a second study in which the procoagulant was delivered following balloon placement, the sealing device was successfully deployed and hemostasis was achieved in 20 of 21 attempts (95%) despite removal of the balloon catheter. In a subset of fully anticoagulated animals, hemostasis was achieved in the sealing device-treated arteries at 6.5 +/- 3.4 minutes but in none of the controls (p < 0.001). This novel vascular sealing device successfully achieves rapid hemostasis in normal and anticoagulated dogs following percutaneous vascular procedures.
Gershony
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John Muir Medical Center, Walnut Creek, California, USA. ggershony@vascularsolutions.com
Jensen
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T
D000818:Animals; D000925:Anticoagulants / Q000008:administration & dosage; D002404:Catheterization / Q000295:instrumentation*; D002986:Clinical Trials as Topic; D003094:Collagen / Q000008:administration & dosage; D003627:Data Interpretation, Statistical; D004285:Dogs; D005263:Femoral Artery; D005500:Follow-Up Studies; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006490:Hemostatics / Q000008:administration & dosage; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D011677:Punctures / Q000295:instrumentation*; D013917:Thrombin / Q000008:administration & dosage; D013997:Time Factors
D000925:Anticoagulants; D006490:Hemostatics; D006493:Heparin; D003094:Collagen; D013917:Thrombin