To: Dr. David P. Summers who wrote (924 ) 5/29/1998 10:31:00 PM From: Jeffrey L. Henken Respond to of 2887
David did you ever read this study by Dr Samuel S Ahn?A PROSPECTIVE, RANDOMIZED STUDY COMPARING THE IMMEDIATE EFFECTIVENESS OF American BioMed, Inc., THROMBECTOMY CATHETERS VERSUS THE BAXTER BALLOON CATHETER PURPOSE: To conduct a prospective, randomized study to compare the immediate effectiveness of American BioMed balloon thrombectomy catheters versus the Baxter balloon thrombectomy catheter. MATERIALS AND METHODS: Twenty consecutive patients with thrombosed vessels and/or ateriovenous fistulas underwent a thrombectomy procedure. Ten patients were randomized to thrombectomy with American BioMed balloons, and ten to thrombectomy with the Baxter Fogarty balloon catheter. Intraoperative data collected included the number of catheters used per case, the number of passes made per catheter, and the number of balloon ruptures. The immediate outcome of each procedure was measured by both radiological(angiogram) and clinical parameters and the procedure was deemed an initial success if patency of the conduit was initially restored. RESULTS: Twenty thrombectomies were performed over a six-month period. Eleven(55%) thrombectomies were performed in native peripheral arteries or bypass grafts, while nine(45%) were completed in hemodialysis arteriovenous PTFE graft fistulas. A mean of 1.4 Baxter catheters were used compared to 1.2 American BioMed catheters per case(range 1-2). With American BioMed catheters, a mean of 4.2(range 1-8) passes were made per catheter. An average of 3.9(range 1-10) passes per catheter experienced balloon ruptures, while only 1(8.3%) of 12 American BioMed catheters ruptured. All procedures performed with American BioMed and all thrombectomies performed with the Baxter balloon enjoyed initial technical success. The clinical success rate for both American BioMed and Baxter Fogarty balloons was 90% due to the fact that one patient from each group required removal of an infected arteriovenous PTFE graft. There were no complications in either group.CONCLUSION:Thrombectomies performed with American BioMed catheters resulted in a lower mean number of catheters used per case. We attribute this lower mean number of catheters per case to the statistically significant(p<0.05) decreased frequency of rupture of American BioMed catheters when compared to the Fogarty balloon. There was no significant difference between the immediate success rates of the two devices. We conclude that while the two devices have comparable immediate effectiveness, thrombectomy with American BioMed balloons reduce the number of catheters needed, thus possibly reducing the time and cost of thrombectomy procedures. Sounds like another great reason why American BioMed has seen an a very real and measurable increase in catheter sales year over year the last two quarters.They make better catheters that can save time and money for physicians and these catheters are much safer for their patients. Regards, Jeff