SYNERGY™ XD

Everolimus-Eluting Platinum Chromium Coronary Stent System

SYNERGY™ BP Stent Clinical Overview

The SYNERGY™ Bioabsorbable Polymer (BP) Stent Platform has been studied in over 35,000 patients across various patient and lesion complexities.

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Heal With Confidence: Leading in Complex Patients

SYNTAX II Trial

The SYNTAX II Trial utilizing the SYNERGY™ BP Stent, physiological assessment, IVUS guidance, and contemporary state-of-the art PCI techniques demonstrated CABG-like outcomes in patients with three-vessel disease at 3-years.*†¹

Low rates of revascularization, peri-procedural MI, and acute ST suggests that contemporary technologies might help in reducing procedural related complications.

* Angiographically detected.
† The safety and efficacy of the SYNERGY™ Stent has not been established in patients with 3 vessel disease or CTO lesions
‡ Patient oriented composite endpoint (POCE) is a composite of all-cause death, any stroke, any MI, and any revascularization..

SYNTAX II Trial
  

Consistently Low ST Rates

Kang Network Meta-Analysis

SYNERGY™ BP Stent ranked #1 for the lowest relative risk of def/prob ST At 1-year. §²

Kang Network Meta-Analysis

§ Caution should be taken in interpreting study results, as some stents had limited numbers of comparisons, and some of the studies had a potential risk of bias. All PtCr-EES stents, also includes PROMUS Element and PROMUS Element Plus. Def/prob ST was available in 110 studies and 111,088 patients.

SCAAR Registry

Lowest ST rate compared to newer generation DES (n-DES) despite use in patients with statistically more Class B2/C lesions, diabetes, prior PCI, and 3VD.*,**,³

SCAAR Registry

* Angiographically detected.
** Some patients in the SCAAR study were treated for either Left Main, CTO, or multi-vessel disease but did not show statistical significance. The safety and efficacy of the SYNERGY™ BP Stent for those uses has not been established. A total of 7,886 SYNERGY™ stents and 64,429 other n-DES (BioMatrix, N=1,953; Orsiro, N=4,946; Promus Element Plus, N=2,543; Promus PREMIER, N=20,414; Xience Xpedition, N=7,971, Resolute/Resolute Integrity, N=19,021; Ultimaster, N=1,156; and Resolute Onyx, N=6,425) were implanted in 42,357 procedures.

 

Leading On Studying Short DAPT

Supporting well-constructed prospective Short DAPT clinical trials with over 5,000 patients to study the SYNERGY™ BP Stent in various complex patient populations

 

EVOLVE Short DAPT Trial: Primary Endpoint Results 12 Months Post-DAPT Discontinuation

Studied the safety of discontinuing DAPT at 3-months in high bleeding risk (HBR) patients using the SYNERGY™ BP Stent.4

 

ARC definite/probable ST
vs. performance goal4

Low ARC definite/probable

0.2% ST Rate

3-month DAPT with SYNERGY™ BP Stent

ARC definite/probable ST vs. performance goal chart

†† Patients with respective event or sufficient follow-up included in the denominator.

Adjusted death/MI with 3-month DAPT
vs. historical control

3-month DAPT with SYNERGY™ BP Stent

Non-Inferior

to 12-month DAPT in a historical control

Adjusted death/MI with 3-month DAPT vs. historical control chart

†† Patients with respective event or sufficient follow-up included in the denominator.
‡‡ Worst-case scenario analysis: site-reported MI in control group between 0-12 m assumed within 0-3 m if not CEC adjudicated. Death/MI endpoint is comprised of HBR subjects from HCRI DAPT Study and PROMUS Element post-approval studies that meet the EVOLVE Short DAPT criteria.

 

SENIOR Trial: Safety Data at 2-Years

The SYNERGY™ BP Stent continued to show superior results versus REBEL BMS with short BMS-like DAPT regimen at 2-years.5

 

All patients

All patients chart

*** Bleeding Academic Research Consortium (BARC).

1-month DAPT discontinuation cohort§§ 

1-month DAPT discontinuation cohort

§§ In patients eligible for 1-month DAPT in this study. Please review the SYNERGY™ DFU for full instructions on DAPT.

 

POEM Trial: 1-year Results

At 1 year, in an all-comers HBR patient population, the SYNERGY™ BP Stent with 1-month DAPT beat the performance goal derived from LEADERS FREE6:

POEM Trial: 1-year results

*The safety and effectiveness of the SYNERGY™ BP Stent has not been established in Left Main or bifurcation lesions. Please review the SYNERGY™ IFU for full instructions on use.

  

Excellent Outcomes in Long Lesions

EVOLVE 48 Trial: Final 2-year results

Supports the safety and effectiveness of the SYNERGY™ XD 48 mm BP Stent for the treatment of long lesions.†††7

  • 100 patients
  • 15 sites across US, Europe, and New Zealand
  • 100% B2/C lesions
  • 27% diabetes mellitus
 

5.1%

Target lesion failure‡‡‡

 

0%

ARC def/prob ST

 

100%

Technical success

 

100%

Clinical procedure success

 

††† Clinical data conducted with SYNERGY™ 48 mm, SYNERGY™ XD’s predecessor device, which can be used to illustrate SYNERGY™ XD 48 mm clinical data.
‡‡‡ Defined as any ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death

 

Excellent Outcomes in STEMI Patients

CLEAR SYNERGY™ Stent Registry: Primary Endpoint Results

At 1 year, in an international, multicenter registry, the SYNERGY™ BP Stent demonstrated low event rates in this high-risk STEMI patient population.8

 

4.8%

MACE

compared to 9.45% performance goal

 

1.0%

Definite ST

 

0.8%

TLR

 
 
Xtra Deliverability

Xtra Deliverability

Learn about the continued advancement in deliverability that SYNERGY™ XD offers

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SYNERGY™ XD 48 mm

SYNERGY™ XD 48 mm

Discover the First 48mm DES approved by US FDA

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Optimal Healing

Optimal Healing

Find out how synchronous drug elution and polymer absorption enables early healing

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