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Procedural Success

Most deliverable DES1, featuring Core Wire Technology

Complex Cases

Broad size matrix to optimise treatment of complex clinical scenarios

Safety Assured

Proven long-term safety and efficacy shown in the Global RESOLUTE Program

1Based on bench test data vs. Promus Premier DES, Synergy II DES, Xience Xpedition DES and Resolute Integrity DES.

 
 

LEARN MORE ABOUT THE ADVANCED WORKHORSE DES POWERED BY CORE WIRE TECHNOLOGY

 

MOST DELIVERABLE DES1

Through an innovative Medtronic-developed process, Resolute Onyx DES is manufactured from a single strand of core wire into a sinusoidal wave form that provides a fluid range of motion

Onyx

Core Wire Technology used to create sinusoid-formed wire

Core Wire Technology enables:

  • Increased deliverability
  • Thinner struts with enhanced radiopacity
  • No compromise to structural strength

Resolute Onyx DES builds on the Integrity platform’s acute procedural success2 for even greater deliverability

Most Deliverable1

graphs

Most Pushable1

graphs

Sustained Radial Strength3

graphs

Core Wire Technology enables thinner struts with increased radiopacity and no compromise to radial or longitudinal strength

  1. Based on bench test data vs. Promus Premier DES, Synergy II DES, Xience Xpedition DES and Resolute Integrity DES.
  2. DELIVER study
  3. Bench test data of 3.00-mm stents on file at Medtronic, Inc.

Broad size matrix to optimise treatment of complex clinical scenarios

A new 2.00-mm diameter with longer stent lengths expands treatment options for patients with diabetes and diffuse disease

Diameter (mm) Stent Length (mm)
2.00 8 12 15 18 22 26 30    
2.25 8 12 15 18 22 26 30 34 38
2.50 8 12 15 18 22 26 30 34 38
2.75 8 12 15 18 22 26 30 34 38
3.00 8 12 15 18 22 26 30 34 38
3.50 8 12 15 18 22 26 30 34 38
4.00 8 12 15 18 22 26 30 34 38
Shaded cells highlight modifications to the size matrix: 2.00-mm stents and 34- and 38-mm lengths expand the size matrix; an 8-mm length replaces the 9-mm Resolute Integrity length; and a 15-mm length replaces the 14-mm Resolute Integrity length.
2.00–2.50-mm stents can be expanded to 3.25 mm; 2.75–3.00-mm stents can be expanded to 3.75 mm; 3.50–4.00-mm stents can be expanded to 4.75 mm.
Onyx
Onyx

Excellent results in extra-small-vessel (RVD ≤2.25 mm) patients2

Onyx
Onyx

Excellent performance in complex patients3

RESOLUTE All Comers showed overall excellent long-term performance at five years:

Low TLF: Resolute ZES 17.1% vs. Xience EES 16.3% (p = 0.65)

  1. One-year data from the RESOLUTE Clinical Program indicates low stent thrombosis rates for those that interrupted or discontinued DAPT any time after one month. While physicians should adhere to current ESC or ACC/AHA/SCAI Guidelines for PCI, patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis. Early discontinuation of prescribed antiplatelet medication could result in a higher risk of thrombosis, MI or death.
  2. Post-hoc RESOLUTE Pooled analysis was not powered for the analysis shown. RESOLUTE FIM, RESOLUTE All Comers, RESOLUTE International, RESOLUTE US, RESOLUTE US 38 mm, RESOLUTE Japan, RESOLUTE China RCT,RESOLUTE China Registry, RESOLUTE Asia, RESOLUTE Japan SVS
  3. Including AMI (within 72 hours), multivessel treatment (>2), renal insufficiency, ISR, bifurcation, bypass graft, LVEF <30%, long lesion (>27 mm), total occlusion, >1 lesion per vessel, thrombus lesion. R-AC was not powered for the analysis shown.
 

Proven long-term safety and efficacy shown in the Global RESOLUTE Program

No increased risk for stent thrombosis with interruption or discontinuation of DAPT after one month1

Resolute Onyx
DAPT

Bhatt. Relation of stent thrombosis to interruption of dual antiplatelet therapy after Resolute zotarolimus-eluting stent Implantation. TCT 2013. Kandzari. Pharmacodynamic considerations and clinical Impact of dual antiplatelet therapy interruption after Resolute zotarolimus-eluting stent implantation. ACC 2014.
Post-hoc RESOLUTE Pooled DAPT analysis was not powered for the analysis shown.
* Including patients with no DAPT interruption except for ST while on DAPT through 12 months.
† Three-day cutoff selected because studies have shown that discontinuation of at least three days is necessary for platelet function recovery in most individuals.
‡ Patient with a history of thrombosis was on DAPT at the time of ST event but had interrupted DAPT for two consecutive days prior to the event.
§ Kirtane. Long-term impact of antiplatelet therapy interruption on ST following PCI with the Resolute zotarolimus-eluting stent. TCT 2013.
ESC guidelines recommend DAPT duration of 6–12 months after DES implantation in all patients and one year after ACS, irrespective of the type of implanted stent.

graph

Sustained safety of 1.2% ST through five years in more than 7500 patients from the RESOLUTE Pooled analysis

DAPT language in CE Mark IFU

Significant statement of finding:

“One year data from the RESOLUTE Clinical Program indicates low stent thrombosis rates for those that interrupted or discontinued DAPT any time after one month. While physicians should adhere to current ESC or ACC/AHA/SCAI guidelines for PCI, patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis.”

Medtronic has added this significant statement of finding to our labelingin order to provide important information to implanting physicians.

  1. Silber S et al. Eur Heart J. 2014;35(29):1949–1956.
  2. Di Mario C. Safety update and long-term clinical outcomes from all studies in the RESOLUTE Global Clinical Program. EuroPCR. 2014. Post-hoc RESOLUTE Pooled analysis was not powered for the analysis shown.
  3. RESOLUTE FIM, RESOLUTE All Comers, RESOLUTE International, RESOLUTE US, RESOLUTE US 38 mm, RESOLUTE Japan, RESOLUTE China RCT, RESOLUTE China Registry, RESOLLUTE Asia, RESOLUTE Japan SVS

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Not for distribution in the USA, Japan or France. © 2014 Medtronic, Inc. All rights reserved. UC201503725ML 11/14