6. Burst pressure is higher in the compression anastomosis at zero-time than in the stapled anastomosis, and remains higher through month 3.
7.
8.
9. Burst pressure is higher in the compression anastomosis at zero-time than in the stapled anastomosis, and remains higher through month 3.
10. The circumference of the compression anastomosis grew in size by 11% compared to zero time, whereas the stapled anastomosis resulted in a 12% loss in lumen size.
14. Meta-Analysis of Human Cases To date more than 1050 clinical procedures were conducted. Clinical work is being conducted in: The US (including Canada), EU (Belgium, Sweden, Germany, Austria, Greece, Holland, Italy & Turkey) Israel South Africa Over 115 Medical Centers Over 180 Surgeons Patients were 60% female, 40% male Average age – 62 (14 to 90) Overall leak rate now approximately 2%
15. Marketing Summary – March update 1063 procedures were recorded during 14 months of use. USA – 525 (49%) ROW – 538 (51%) 116 Medical Centers 181 Surgeons (average 5.9 procedures per surgeon)
22. Phase IV Study: What is phase IV study? Post marketing study is a study that is conducted after FDA approval for a product to gather additional information about a product's safety, efficacy, or optimal use. Prospective multi-center study of the Colon Ring for creation of circular rectal anastomosis. Including 20 Sites situated in Europe and the US, 300 Patients. Planned to start in Q’1, 2009--delayed.
23. Inclusion Criteria Patient is over 18 years old. Patient is scheduled for a non-emergency procedure. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures. Proprietary Information
24. Exclusion Criteria Patient has an allergy to nickel. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensive inflammatory bowel disease. Patient is participating in another clinical trial which may affect this study’s outcomes. Patient has been taking regular steroid medication. Patient has contraindications to general anesthesia. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis. Proprietary Information
25. Comparison Study A Comparison between Surgical Staplers and the Colon Ring for Creation of Circular Colorectal Anastomosis Including 8 sites, 150 Patients. 100 in the study arm and 50 in the control arm. Planned to start in Q3 2009.
