1. The Next Era in GI Surgery BioDynamixTM Anastomosis The Colon Ring HISTORY OF Compression Anastomosis Clinical Training Team

2. Routine Anastomotic Techniques—Handsewn vs. Staples Until recently, there were only two routinely used techniques No difference whether sewn in one or two layers Stapling is faster Surgeon preference prevailed Literature supports whichever the surgeon uses

3. 3 “Eminence-”…(Instead of Evidence-)…Based Medicine Results in— “Repeating the same mistakes with increasing confidence over an impressive number of years.” O'Donnell M. A sceptic's medical dictionary. London: BMJ Books, 1997.

4. 4 The Velocity of Change When change occurs— “The lag between the discovery of more efficacious forms of treatment and their incorporation into routine patient care is unnecessarily long, in the range of about 15 to 20 years.” Institute of Medicine Crossing the Quality Chasm 2001

5. Change Is Hard

7. CA consistently compresses the blood vessels, creating an immediate and virtually complete hemostasis.

8. CA device requires no foreign bodies (sutures, staples) to remain in the healing zone after 10-14 postoperative days.

10. Controlled local ischemia leads to necrosis, triggering a natural healing process.

12. Earliest practical device, the “Murphy Button” dates to 1891

13. More recent products –Valtrac (BAR) - introduced in 1984 AKA-2 ring (Russia)

14. Murphy Button Two circular metallic rings Scalloped in the shape of a bowl Double purse strings Steel alloy coiled spring Necrosis of compressed tissue Very narrow lumen Frequent extrusion Limited clinical success Stenosis/Stricture - early or late 1891

16. 87.5% polyglycolic acid

17. 12.5% barium sulfate

18. No springs

19. Double purse string

20. Snapped shut (clamp)

21. Four sizes—25, 28, 31, 34

22. 1.5-2.5 mm gap

23. ID size 11-20 mm

24. Passed transanal in 2-3 wks

25. Often incomplete absorption

26. Decent results

27. Difficult to use1984

29. Plastic anvil ring w/metal screw

30. Transanal applier w/

31. Double plastic rings

32. Multiple spikes

33. 6 blunt pins

34. 18 fish-hook pins

35. Coiled steel alloy springs

36. Double purse string

37. No consistent compression

38. Necrosis of incorporated tissue

39. Passed out with stool

40. Used primarily in Germany1989

41. Detachable Anvil Head Assembly Trocar Operating Knob Cutting Trigger ColonRing™Housing Cutting Handle ColonRingTM Purse String Notch Plastic Anvil Ring Locking Spring Anvil Shaft Grasping Notch ColonRingTM Applier

42. Nitinol’s Basic Properties The Colon Ring™ is manufactured with Nitinol, a biocompatible alloy of nickel and titanium with several unique properties – Shape Memory – Unlike steel, Nitinol fully recovers its shape when heated past a transition temperature. Superelasticity – Nitinol can be stretched far beyond the limits of other metal alloys (~20 times more than steel), while still remaining capable of returning to its original shape. Constancy of Force – When deformed 1% to 6% from its predefined shape, Nitinol applies a consistent force range as it returns to its original shape. (Relaxes in cold and contracts in heat.)

43. Leaf Work Zone Work Zone 6%-1% Nitinol Leaf Spring at 6% Deformation Nitinol Leaf Spring at 1% Deformation Steel Leaf Spring at 0.4% Deformation Nitinol Leaf Spring at 0% Deformation

45. Nitinol’s Constancy of Stress (Force)

46. How the ColonRingTM Works Nitinol Spring Leaf at 6% Deformation (Thick Tissue) Nitinol Spring Leaf at 1% Deformation (Necrosed Tissue) Nitinol Spring Leaf at 3% Deformation (Thin Tissue)

47. Variation of Tissue Thickness within the Colon RingTM Tissue Thickness Tissue Thickness Nitinol Spring Leaf at 3% Deformation (Thin Tissue) Nitinol Spring Leaf at 6% Deformation (Thick Tissue) Leafs within the same ring can tolerate different deformation levels while still exerting almost the same force around the entire ring.

48. Application of the Colon RingTM The gap between the two ring elements adjusts according to tissue thickness. With greater tissue thickness, a larger gap is obtained (up to maximum). The Nitinol springs adjust the initial gap by compressing the tissue with a predefined force. The Nitinol springs within the ring act along the unloading plateau path (6%-1% of Strain) where a nearly constant force acts on the tissue. The fact that a nearly constant force can be obtained gives the Colon RingTM the ability to control the compression process. As the compression process progresses, the tissue trapped between the rings necroses, while the new anastomosis forms externally, and the gap decreases until "zero" gap occurs. At "zero" gap the ring detaches and is expelled naturally by intestinal peristalsis.

50. Controlled local ischemia leads to necrosis, triggering natural healing process

52. Lumen Size -- Staplers 21

54. Compact anvil design allows for easy removal after ring is placed.

55. No anvil head is dragged through a fresh anastomosis.

57. Lawn Care Preference?

58. Landscape Preference?

59. Surgeon (and/or Patient) Preference? (at 3 Months) EEA Stapler w/Strictured Anastomosis ColonRingtm w/Almost Seamless Anastomosis

60. Surgeon Preference? Tissue Structure at 3 Weeks

61. ColonRing™ Anastomosis Appearance Postop 3 Months PO

62. Compression Anastomosis vs. Staplers

63. NiTi ColonRingTM Company Data 435 Averages represent averages of all data received for a given data point Data collected from over 600 surgeons at 375 sites in North America, Europe and Asia Sites range from major university medical centers to community-based hospitals Patients were 56% female, 44% male Procedures were 7% right hemicolectomy, 48% left hemicolectomy, 45% anterior resection Cases were 50% open and 50% lap Average age – 62.4 (14 to 91) Average BMI – 28.1 (16 to 55) Over 8,000 cases performed worldwide Of the 3,500 AR procedures, more than 450 involved chemo-radiated patients In all 7,641 commercial cases covered in this document, a clinical leak rate of 3.0% (228 cases) was reported. 156 15% 42% 40 4% 402 39% >25 cm <10 cm 11-15 cm 16-25 cm Height of Anastomosis In 1,033 Cases