1. DES Bioabsorbable and DCB Technologies
CRT February 25th 2013, Washington DC
Martin T Rothman MB, ChB, FACC FESC FRCP
Vice President Medical Affairs
Coronary & Renal Denervation
Medtronic Inc.
Professor of Interventional Cardiology
Barts Health
London, UK

2. Martin T. Rothman, MD, MB, ChB
I/we have no real or apparent conflicts of interest to report.

3. Integrity build animation

4. Continuous Sinusoid Technology The Next Revolution in Stent Technology
Bare Metal Stents
Integrity
Enabling designs that could not be attempted in the past
Drug-Eluting Stents
Resolute Integrity
S10
Core Wire
New Alloys
Platforms for next gen DES coatings
BioLinx (Resolute)
PC Technology (Endeavor)
Bioabsorbable polymer
Nanoporous
CAUTION: Some Design elements not approved for sale or clinical use

5. Core wire design featuring thinner struts than Resolute Integrity
S10 DES
Core wire stent with enhanced deliverability, radiopacity, and size matrix
Attribute
Description
Deliverability
Targeted 10-15% Improvement over Resolute Integrity
Radiopacity
Increased due to core wire technology
Expanded Size Matrix
Long length (34 and 38 mm) sizes at diameters
Integrity
S10
Omega (Element)
ML-8 (Xience)
Is midpoint between Integrity radiopacity and element good enough?
Improved Deliverability
and Radiopacity
Core wire design featuring thinner struts than Resolute Integrity

6. Deliverability – Animal Model
3.0 x 18mm blinded, pairwise testing
Bench testing also showed a 27% improvement in trackability

8. If it catches, what happens?
S10 Platform
SV (2.5) Element was deforming at 50 grams of force
Element
Platform

9. Bioabsorbable Stent Technology
Objective: DES-like performance with clinically relevant degradation time, workhorse performance without sacrificing critical design targets
Design Targets
Medtronic Goal
Efficacy equivalent to DES
In all lesions treated by DES
Adequate radial strength
3-6 months
Appropriate degradation time
6-12 months
Anticipated DAPT duration
Equal or better than current DES
Adequate deliverability & conformability
Similar to current DES
Minimal change to implant procedure
Polymer
Metal
Increased strut size & crossing profile
2+ years degradation
Extended DAPT?
Complex deployment
-Slow inflation
-Limited post-dilation
-Potential for malapposition
Modestly increased strut size & crossing profile
6-12m degradation
Low inflammation
Simple DES-like deployment

10. Strut cross-section after degradation begins to occur
Bioabsorbable Stent Technology
Proprietary Alloy
Balance of consistent performance, mechanical strength/workability, and surface treatment compatibility
Absorption control
Demonstrating controlled dissolution of stent
Day 0
Strut cross-section after degradation begins to occur
Surface treatments control degradation
Target: 3-6mo. structural integrity
12mo. full degradation

11. Bioabsorbable Stent Technology
Promising in-vivo results demonstrated with multiple surface treatment / alloy combinations
In vivo Corrosion
Biocompatibility
Treatment 1
OCT at 30d
Treatment 30d
Treatment 30d
Treatment 1
MicroCT at 30d
Proven good biocompatibility of the alloy and the surface treatments
Good wall apposition and
no visible corrosion
Arm Description
Stenosis %
Neointimal Thickness
Treatment 1
24.20
0.19
Treatment 2
22.47
0.17
Integrity BMS
19.79
0.16
Consistent stent diameter,
good vessel support

12. Continuous Sinusoid Technology The Next Revolution in Stent Technology
Enabling designs that could not be attempted in the past
Bare Metal Stents
Integrity
Drug-Filled Stent
Drug-Eluting Stents
Resolute Integrity
It would not be possible to create a thinner strut cobalt alloy stent (< 0.003”) without compromising radiopacity. That’s where Core Wire and New alloys allow stent designs that would not otherwise be possible without major compromise.
CAUTION: Design concept not approved for sale or clinical use
Resolute and Resolute Integrity are not approved for clinical use in the US
CAUTION: Design concepts not approved for sale or clinical use

13. Drug Filled Stent (DFS) Technology Polymer Free Drug Delivery
Innovative DES design
Essentially a BMS surface
Designed to address drug carrier issues such as:
Polymer biocompatibility
Inflammation upon polymer degradation
Surface coating durability
With CST, Medtronic is working to bring a new concept in DES – a polymer-free Drug Filled Stent
Drug is contained in a small diameter hollow core running the length of the stent and elutes in a controlled fashion via tiny holes
This design is not possible with laser cut technology
From the start, it has a bare metal surface with no durability, biocompatibility, or inflammation issues associated with durable or bioabsorble polymers
Elution rates can be controlled by mechanical means – the size (diameter) and number of the holes
CAUTION: Design concepts not approved for sale or clinical use

14. Drug Filled Stent 28 day histology porcine coronary arteries
BMS
DFS (No Drug)
DFS-1
DFS-2
CAUTION: Design concepts not approved for sale or clinical use

15. Drug Filled Stent 28 day histology porcine coronary arteries
DFS (No Drug)
DFS-1
CAUTION: Design concepts not approved for sale or clinical use

16. DES, Biodegradable, DFS Program for next generation DES well advanced
Enhanced resistance to longitudinal stent deformation
Biodegradable metal stent
Early data very encouraging
Drug filled stent
Advanced program with excellent data