Cre8 BTK
Below The Knee Region / DES B.E. – Cre8™ BTK
Polymer-free Amphilimus™ (Sirolimus + Fatty Acid) eluting stent for lesions in the SFA region.
The absence of polymer minimizes the risk of inflammation/thrombosis, while the proprietary formulation enhances drug absorption.
Features
The proprietary polymer-free Abluminal Reservoir Technology allows a sustained drug release, exclusively towards the vessel wall, up to 3 months, eliminating the renowned drawback associated to the polymers
The Amphilimus™ formulation (Sirolimus + Fatty Acid) enhances drug bioavailability, permeability and maximizes product overall safety and efficacy
Thanks to its haemo and bio- compatibility, the Bio Inducer Surface acts as anti-thrombotic coating and it promotes a fast-healing sealing against heavy metal ions release
The drug efficacy is maximized by the prolonged, controlled and targeted elution to the vessel wall. The endothelialization process is not delayed by the presence of any polymer or drug.
In diabetic cells, as glucose uptake and oxidation are impaired, the uptake of fatty acids is increased in the ATP pathway which also improves the availability of the Sirolimus.
In the very distal arteries, where the blood speed is slow and the platelet interaction with the stent surface is prolonged, the coating contributes to increase device safety.
Peripheral stent
- Polymer-free drug release device
- Stent material: L605 Cobalt Chromium alloy
- Abluminal Reservoir Technology – Sustained elution up to 2-3 months
- Strut surface coating: Bio Inducer Surface – BIS
- Strut thickness: 70 – 80μm
- 2 radiopaque platinum markers at stent ends
- No stent foreshortening during expansion
Drug releasing formulation
- Amphilimus TM formulation: Sirolimus + Fatty Acid Ordering Information
Device specifications
- Rapid exchange
- Introducer sheath compatibility: 4F
- Guidewire compatibility: 0.014”
- Nominal Pressure (NP): 9 ATM
- Rated Burst Pressure (RBP): 18 ATM
- Average Burst Pressure (ABP): 24 ATM
