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SYNERGY™

Everolimus-Eluting Platinum Chromium Coronary Stent System

Heal with Confidence: Leading in Complex Patients

SYNERGY BP-DES was intentionally designed with a fast-absorbing polymer for early healing. The latest clinical data from EuroPCR continues to show low event rates with the SYNERGY BP-DES.

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Indications, Safety, and Warnings

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SENIOR Trial Safety Data with SYNERGY BP-DES in 1-Month DAPT* Cohort at 2-Years1

  • Randomized, single-blind trial evaluating the SYNERGY BP-DES and the REBEL™ BMS in patients 75 years or older with a short duration of DAPT
  • Over 50% of patients enrolled received a 1-month DAPT regimen – largely stable patients
  • Statistical significant 4.5x reduction in ID-TLR with SYNERGY BP-DES vs. best-in-class REBEL™ BMS
  • 0.6% ST with SYNERGY BP-DES

MACCE** at 2-years

Primary Endpoint: MACCE at 12-months

Safety Data at 2-Years

Safety Endpoints at 12-months
*In patients eligible for 1-month DAPT in this study. Please review the SYNERGY DFU for full instructions on DAPT.
**All-cause mortality, MI, stroke, ischemia-driven TLR
 
View the Primary endpoint data and 2-Year All patients results
 

SYNTAX II Trial 2-Year Results2‡

  • Prospective, single-arm, multicenter, open-label trial of patients with de novo three-vessel CAD
  • The MACCE rate (primary endpoint) was significantly lower in SYNTAX II (13.2%) vs SYNTAX I (21.9%). (P=0.001)
  • SYNERGY BP-DES, physiological assessment, IVUS guidance, and contemporary PCI techniques demonstrated equivalent outcomes to CABG in patients with three-vessel disease.† (MACCE rate of 13.2% PCI vs 15.1% CABG, P<0.001 for non-inferiority)

MACCE vs. Historical PCI - 2 Year Results

Primary Endpoint: MACCE vs. Historical PCI - 2 Year Results

MACCE PCI vs. Historical CABG - 2 Year Results

Exploratory Endpoint: MACCE PCI vs. Historical CABG - 2 Year Results
† Angiographically-detected.
 

SCAAR AMI Substudy 2-Year Results3‡

  • Evaluated SYNERGY BP-DES compared to all other new-generation DES in the SCAAR Registry in 36,292 patients with AMI at 2-Years
  • Lowest ST rate with SYNERGY BP-DES in AMI patients despite use in more complex patients and lesions

Definite Stent Thrombosis

Definite Stent Thrombosis

Restenosis

Restenosis
All other newer generation DES included the following stents: Resolute Integrity™, Resolute Onyx™, Xience Xpedition™, PROMUS Element Plus™, Promus PREMIER™, Orsiro™, Biomatrix™, and Ultimaster™. There were 4,889 SYNERGY BP-DES patients and 31,403 ‘other new-generation DES’ patients.
 

CONSISTENT CTO Study 12-Month Results4‡

  • Single-arm, 6 center study of 210 CTO patients evaluating primary end-point of TVF versus performance goal with the SYNERGY BP-DES
  • Low event rates in complex lesions (mean stent length 85.6 mm) and very symptomatic patients

Key Trial Details4

  • 90.5% of patients had pre-PCI IVUS
  • 90% CTO success rate
  • Very complex and symptomatic patients
    • JCTO Score of 2.4
    • Mean stent length 85.6 mm
    • 21% diabetic patients
  • Significant QoL gains at 12-months following successful CTO PCI

TVF at 12-Months

Primary Endpoint: TVF at 12-Months
 

CELTIC Bifurcation Study 9-Month Results5‡

  • Examined outcomes of 170 patients at 8 sites in the UK treated by planned culotte stenting with the SYNERGY BP-DES and the Xience Xpedition™ PP-DES
  • Results showed lower composite primary endpoint, including 0% ST and low restenosis with the SYNERGY BP-DES

Composite Primary Endpoint at 9-Months

Composite Primary Endpoint at 9-Months
‡The safety and effectiveness of the SYNERGY Stent has not been established in multi-vessel disease, CTO lesions or bifurcation lesions.
 
View more clinical data on the SYNERGY BP-DES
 
Early Healing

Early Healing

Advanced design for optimal healing

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Clinical Outcomes

Clinical Outcomes

Outstanding evidence across trials

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Efficiency

Efficiency

How design impacts economic value

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