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
Martin T. Rothman, MD, MB, ChB I/we have no real or apparent conflicts of interest to report.
Integrity build animation
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
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 2.25-2.75 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
Deliverability – Animal Model 3.0 x 18mm blinded, pairwise testing Bench testing also showed a 27% improvement in trackability
If it catches, what happens? S10 Platform SV (2.5) Element was deforming at 50 grams of force Element Platform
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
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
Bioabsorbable Stent Technology Promising in-vivo results demonstrated with multiple surface treatment / alloy combinations In vivo Corrosion Biocompatibility Treatment 1 OCT at 30d Treatment 1 @ 30d Treatment 2 @ 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
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
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
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
Drug Filled Stent 28 day histology porcine coronary arteries DFS (No Drug) DFS-1 CAUTION: Design concepts not approved for sale or clinical use
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