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)
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
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
REMEDEE ACS 1 Year2
(n=499)
40% STEMI patients
NUHS AMI Registry 2 Years3
(n=260)
10.9% with cardiogenic shock
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
MASCOT Registry 1 Years5
(n=2,614)
56% ACS patients
Technical Specifications
Stent
| Drug (dose) | Sirolimus (5.0 μg/mm |
|---|---|
| Polymer | Abluminal bioabsorbable |
| Biological coating | Anti-CD34 antibody |
| Side Branch Access | 4.5 mm |
| Radial Strength | > 25 psi |
| Foreshortening | < 1% |
| Recoil | < 5% |
Delivery system
| Catheter type | Rapid exchange |
|---|---|
| Guide catheter compatibility | 5F |
| Guidewire compatibility | 0.014” |
| Coating (distal shaft / tip) | Hydrophilic coating |
| Nominal pressure (NP) | 9 atm |
| Rated burst pressure (RBP) | 16 atm |
Schematic
Compliance Chart
| Pressure (atm) | 2.5 mm | 2.75 mm | 3.0 mm | 3.5mm | 4.0 mm |
|---|---|---|---|---|---|
| 6 | 2.43 | 2.68 | 2.92 | 3.41 | 3.89 |
| 7 | 2.45 | 2.7 | 2.94 | 3.44 | 3.93 |
| 8 | 2.48 | 2.73 | 2.97 | 3.47 | 3.96 |
| 9 NOM | 2.5 | 2. 75 | 3 | 3.5 | 4 |
| 10 | 2.52 | 2.77 | 3.03 | 3.53 | 4.04 |
| 11 | 2.55 | 2.8 | 3.06 | 3.56 | 4.07 |
| 12 | 2.57 | 2.82 | 3.08 | 3.59 | 4.11 |
| 13 | 2.59 | 2.85 | 3.11 | 3.62 | 4.14 |
| 14 | 2.61 | 2.87 | 3.14 | 3.66 | 4.18 |
| 15 | 2.64 | 2.9 | 3.17 | 3.69 | 4.21 |
| 16 RBP | 2.66 | 2.92 | 3.19 | 3.72 | 4.25 |
| 17 | 2.68 | 2.94 | 3.22 | 3.75 | 4.29 |
| 18 | 2.7 | 2.97 | 3.25 | 3.78 | 4.32 |
| 19 | 2.73 | 2.99 | 3.28 | 3.81 | 4.36 |
| 20 | 2.75 | 3.02 | 3.3 | 3.84 | 4.39 |
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COMBO® Plus is not approved for sale in the USA.
