- A new proprietary sternal closure device called the Figure 8 device has been developed as an alternative to traditional steel wires which are prone to failure and damage bone.
- Benchtop testing and an early clinical trial show the Figure 8 device provides a more stable and secure closure that reduces pain and costs compared to steel wires.
- The Figure 8 device is nearing full clinical release and FDA approval after completing design testing, cadaver studies, and an initial clinical trial that demonstrated benefits over steel wires in metrics like stability, pain levels, and hospital costs.
2. introduction
• proprietary* evolution in sternal closure technology
• conceived by experts in sternal reconstruction
• driven by experienced medical device entrepreneurs
• endorsed by leading academic surgeons
• a Delaware corporation, self-funded since inception
* multiple patent applications filed
3. our team
• W. Thomas McClellan, MD
Harvard / Tufts / Duke/ Emory Plastic & Hand Surgery
• Johnny Chang, MD, MSME
Brown Plastic Surgery & MIT Mechanical Engineering
• Cortland Bohacek, MBA
• John Krumme, BSME, MSME
Medical Device Development
• Scott Heneveld
Product Design & Testing, FEA/CAD
4. advisors
• Gary Fanton, MD
Stanford Director of Orthopedic Sports Medicine
Founder of Sapphire Medical & Oratec Interventions
• Gordon Murray, MD
Immediate Past President, Society of Thoracic Surgeons
• Kee Lee, MD
Board Certified Cardiothoracic Surgeon
• Tom Fogarty, MD
Surgeon, Entrepreneur, Investor
10. the problem
twisted steel wires
• what’s wrong with steel wires?
• prone to failure at multiple stress points
• damages bone = cut-through
11. background
twisted steel wires
• what’s wrong with steel wires?
• imprecise & operator-dependent
• “tightness” & security is subjective
• does not provide multi-axis stability
12. why a new closure?
• 600,000 elective median sternotomies per year, closed with dated,
rudimentary steel wires
• 40,000 sternal complications
• Future – Older, Sicker (Diabetic, Renal Failure, Smokers), Redo’s
• Never Event – Medicare no longer pays for complications ($80k - $100k)
13. alternatives to wire
Synthes Plates
($3000 - $6000/pt)
Talon System ($2900/pt + tools)
Myowire ($800/pt) Pioneer Cable System ($300/pt + tool)
14. existing sternal closure devices
• why haven’t these alternatives caught on?
• complicated & time-consuming to use
• unfamiliar techniques
• significant additional training & equipment
• targeted for small secondary markets only
• extremely expensive
17. why figure 8 is better
• lower cost
• easier to apply using the same technique and equipment
• same amount of time
• lower profile and off midline
• standard and reproducible by different surgeons
18. why figure 8 is better
• can go through manubrium
• multiple configurations available
• reversable
• easy re-entry
19. why figure 8 is better
• wider footprint + less vertical force to place
= less cut-through
• more stable in multiple directions
• security mechanism doesn’t weaken construct
• able to solve partial sternotomy
• primary closure market
26. figure 8
partial sternotomy solutions
Apply devices
Two Single
bands
27. clinical trial
Usability, Safety, and Efficacy of the Figure
8 Sternotomy Closure Device
Early Snapshot of Results: Aug – Dec 2011
Investigator: Kee Lee, M.D.
28. clinical trial: details
• prospective, randomized
• patient blinded
• single CT surgeon – board certified
• as of december 2011
• 18 pts figure 8 device group
• 15 pts #7 ethicon wire group
29. Age
-‐
Years
(avg)
70
62.5
62.75
60
50
40
Axis
Title
30
20
10
0
Fig8
Wires
30. Body
Mass
Index
–
(avg)
40
35
30.08
29.41
30
25
20
15
10
5
0
Fig8
Wires
32. Bypass
Off
to
Case
End-‐
Minutes
(avg)
100
90
80
70.82
70
60
53.16
50
40
30
20
10
0
Fig8
Wires
Closure occurs during this time.
33. Length
of
Stay
–
Days
(avg)
8
7.58
7
6
5.66
5
4
3
2
1
0
Fig8
Wires
Shortest and Longest admission dropped from each group
34. Pain
on
Visual
Analog
Scale
(0-‐10)
(avg)
5
4.5
4.5
4
3.5
3
2.8
Fig8
2.5
2
Wires
40% less pain
1.5
1.55
1
1
1
0.5
0.22
0
D/C
30
days
60
days
35. Surgery to Discharge Cost (Dollars)
90000
85000
80000
75000
70000
82896
65000
73187
60000
55000
50000
Fig8 Wires
12% less cost
36. where are we
• FDA 510(k) approved
• IRB approval Clinical Trial in progress
• FDA Certified manufacturer in place
• Full clinical release ~ 3 weeks
• bench top testing completed
• white paper + cadaver evaluations completed
• excellent patent position 3 non-provisionals, 3 provisionals
