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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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Directions for Use

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Indications, Safety, and Warnings

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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 and ONLY 48 mm DES available in the U.S.

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Optimal Healing

Optimal Healing

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

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