COMBO - Model Plus - Dual Therapy Stent

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.

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.

COMBO’s dual helix design is engineered for:

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

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.

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.

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

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