D2232 g v01 rev. 1 j.schneider, how tryton will change daily practice

1. How Tryton Will Change Daily Practice
Joel Schneider, MD FACC
UNC-­Rex Healthcare
Raleigh, NC
Tryton Medical TCT Symposium
October 31, 2016
“create order out of chaos”

2. Disclosure Statement of Financial Interest
I, Joel Schneider, MD do not have a financial interest/arrangement or
affiliation with one or more organizations that could be perceived as a real or
apparent conflict of interest in the context of the subject of this presentation.

4. “Cognizant of
economics
and his resource use”
“Constantly trying to learn
and improve his skills”
“Essential that he is efficient,
effective, and focused
on patient care”
Age: 55years old
Family: 2 grown children
Experience: 20+ years
“It’s a calling when you do this for a living…”

5. What does Carl want from Tryton
• New approach to bifurcation PCI
• Predictability and Improved Outcomes
• Cost Neutral or Defensible

6. Dilemma of Bifurcation Disease
vs

7. CONFIDENTIAL – NOT FOR DISTRIBUTION
• Methodology not established
• Technically complex
• Unpredictable results
• Increased procedural time
• Higher costs
• Increased risk for stent thrombosis
• Recurrent ischemia from side branch
residual disease
• Higher restenosis rate
• Duration of DAPT unclear
• Repeat intervention options limited
• Procedural Concerns • Post Procedural Concerns
Clinical Dilemma of Bifurcation Disease

8. Tryton takes the side branch out of play
…Avoids the unpredictable nature of BIF and its consequences

9. Eliminate Two Stent Strategies for Bifurcation
T Stenting V Stenting Y Stenting Culotte * Crush*
Kissing Stent* *”gap” coverage

10. RCT and Confirmatory Study Combined
Tryton (n= 279)
Tryton: Side Branch Status

18. “All Comers” Studies % Patients % Lesions
Leaders Trial1,2 29.1% 21.6%
Nobori 23 17.5% 16.9%
xSearch4 22.2% N/A
Average 22.9% 19.3%
1. Windecker et al. Lancet 2008;; 372: 1163–73
2. Wykrzykowska, EuroPCR ’09
3. Danzi, EuroPCR ‘09
4. Serruys, ACC ‘08
How often will bifurcations come up in clinical practice?

19. Bifurcation Total PCI
Volume
Total 360 3,492 10.3%
UNC-­Rex 283 2,716 10.4%
Medical
Center
77 776 9.9%
National 108,672 979,245 11.1%
BIFURCATION PCI NCDR DATA
CY 2015
US Potential Usage Estimated @ 15%: 146,886 Implants

20. BIFURCATION LESIONS at UNC-­Rex and
Medical Center
1.41
2
1.36
2
1.41
2
0
0.5
1
1.5
2
2.5
REX UNC
Average Number of Stents per Bifurcation Lesion
Average Stents per Lesion
2014 2015 2016

22. Bifurcation Cost Considerations
Values Bifucated Lesion Other PCI Grand Total
Count of Account Number/HAR 210 1,563 1,773
Average of Total Payments and
Settlements 18,354 16,399 16,631
Average of Implant Cost (1DV) 2,633 2,435 2,459
Average of Drug Cost (3DV) 610 531 541
Average of Total Variable Cost (incl.
Implant and drug) 10,273 9,286 9,403
Average of Contribution Margin 8,082 7,113 7,228
Average of Operating Income (Loss)
w Settlements 1,578 1,511 1,519
Average of IP Days (Length of stay) 1.9 1.9 1.9

23. 2013 Tryton OUS Experience:
>12.000 Patients Treated in > 30 Countries
>1.800 Patients Studied by > 80 Physicians

24. The Tryton in the Hat?
“create order out of chaos”

25. Tryton Experience: Learning Curve
Faster procedures, Reduced Fluoroscopy, and Less Contrast
as Experience Grows