COMBO

Dual Therapy Stent

Early and complete healing
Durable safety and clinical performance
Optimal scaffolding

The Pro-Healing DES

COMBO Plus is more than just a drug-eluting stent (DES).
It is a combination of traditional DES components with the addition of a biological coating.

Sirolimus Release from a Bioabsorbable Polymer

The proprietary bioabsorbable polymer is coated on the abluminal side of the stent, allowing
for directional drug release in 30 days and polymer absorption in 90 days.

Dual Helix Stent Design

COMBO Plus’ dual helix design is engineered for:

  •   Excellent radial strength
  •   Large side branch access
  •   Natural conformability

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COMBO Plus with EPC capture technology promotes early vessel healing and has consistently demonstrated, via multiple clinical studies, its safety and effectiveness in both acute and stable patients, providing them with the flexibility of short  DAPT option, if needed.

Key Clinical Findings

Unique 24-Month Neointimal Regression

A mechanistic study demonstrated that repeat OCT follow-up in the same patients showed a significant decrease in neointimal thickness and volume at 24-month compared to 9-month follow-up, indicative of neointimal maturation and stability.

Strut Level Neointimal Thickness (mm)

S. Lee et al. The EGO-COMBO study. Circ .Cardiovasc Interv.2016;9e0034609

Strut Level Neointimal Volume (mm3)

Multiple studies have consistently shown low event rates

Superior Healthy Tissue Coverage

Significantly greater and healthier tissue coverage at 1 year on 140 subjects under OCT analysis

S. Saito, HARMONEE Study, European Heart Journal, April 2018

Several trials including a randomized study dedicated to patients with Acute Coronary Syndrome (ACS) and registries with a sizeable ACS patient subset demonstrated consistently low event rates and short DAPT option of 3 months, if needed.

REDUCE ACS 2 Year1
(n=1,460)

47% STEMI patients

1 G. de Luca et al, REDUCE Study, EuroIntervention, August 2019

REMEDEE ACS 1 Year2
(n=499)

40% STEMI patients

2 Kalkman DN et al, Catheterization and Cadiovascular Interventions, 2017;90:E31-37

NUHS AMI Registry 2 Years3
(n=260)

10.9% with cardiogenic shock

3 Sim HW et al, Cardiovascular Revascularization Medicine, November 2018

Two all-comers registry studies which recruited high risk, complex patients globally demonstrated low event rates.

REMEDEE Registry 5 Years4
(n=1,000)

50% ACS patients

4 L.S. Kerkmeijer et al. Catheterization & Cardiovascular Interventions, October 2020

MASCOT Registry 1 Years5
(n=2,614)

56% ACS patients

5 Colombo et. al, MASCOT Registry 1-year data, International Journal of Cardiology, January 2019

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Clinical program

View the Clinical Trials