Sirolimus coated balloon
Bio-sphere technology

The Latest Generation of Drug Coated Balloon

BIO-SPHERE TECHNOLOGY
Sirolimus:
    - 1.27 µg/mm²
    - Cytostatic effect
    - Drug most widely used for Drug Eluting Stents

Cell-Membrane Bio-Mimicking Carrier
  • Better compatibility & acceptance in tissue
  • Promotes healing and assists in endothelialization

Small Size for Higher Uptake
  • Easier & faster transfer into arterial tissue

Bio-Sphere Drug Encapsulation
  • Stabilization & protection

Two-steps release
  • Bio-spheres transfer into tissue
  • Drug release from bio-spheres




Homogeneous Drug Repartition within 7 days

COATING PROCESS

Effective Adhesion to Balloon Surface
  • No coating delamination
  • Low "particulate" generation

Uniform Surface Coating
  • Homogeneous drug distribution
  • Protection during transit (between the folds)

* data on file

RELIABLE DRUG DELIVERY PLATFORM
- 5F Guiding Catheter Compatible
- Distal Shaft Hydrophilic Coating
- 0,016” Entry Profile
- Semi-Compliant Balloon material


Yangtze µ catheter system physicians feedback: 642 cases*
* data on file


PRE-CLINICAL DATA
Safety and Efficacy verified

Histological Evaluation after 28 days implantation*
Effective reduction of neo-intimal hyperplasia
* data on file



Pharmacokinetic evaluation*
  • Low Sirolimus blood levels
  • Lower blood levels compared to Sirolimus Eluting Stent (SES)
  • Sirolimus retention up to 14 days
  • Higher concentration compared to Sirolimus Eluting Stent (SES)
* data on file

Clinical Data
Observational study for safety and performance demonstration

DEVOIR clinical
results

Learn More...



12 months cumulative clinical results

Overall population (n=251)
ISR subgroup analysis (Lesion=136)
Small vessel subgroup analysis (Lesion=106)

Specifications

Indications
The DEVOIR Sirolimus coated balloon is indicated to dilate the diseased segment(s) and deliver drug in a coronary artery to improve myocardial perfusion with lesion lengths ranging from 8 to 38 mm and diameters ranging from 1.50 mm to 4.00 mm.
Drug Sirolimus
Drug dose 1.27 µg/mm²
Drug carrier Phospholipid based excipient
Balloon material Polyamide blend (Semi-compliant balloon)
Catheter design Rapid Exchange design
Shaft diameter - Proximal 1.7 F
Shaft diameter – Distal 2.5 F
Usable catheter length 140 cm
Tip profile 0.016"
NP* 6 bar
RBP* 16 bar (14 bar for 4.00 / 25 to 40 mm)
Guiding catheter compatibility 5F (0.058" ID) for all sizes
Guidewire compatibility 0.014" maximum recommended

Ordering information


LENGTH (mm) DIAMETER (mm)
1.50 2.00 2.25 2.50 2.75 3.00 3.25 3.50 4.00
10 CDE15010 CDE20010 CDE22510 CDE25010 CDE27510 CDE30010 CDE32510 CDE35010 CDE40010
15 CDE15015 CDE20015 CDE22515 CDE25015 CDE27515 CDE30015 CDE32515 CDE35015 CDE40015
20 CDE15020 CDE20020 CDE22520 CDE25020 CDE27520 CDE30020 CDE32520 CDE35020 CDE40020
25 CDE15025 CDE20025 CDE22525 CDE25025 CDE27525 CDE30025 CDE32525 CDE35025 CDE40025
30 CDE15030 CDE20030 CDE22530 CDE25030 CDE27530 CDE30030 CDE32530 CDE35030 CDE40030
35 CDE15035 CDE20035 CDE22535 CDE25035 CDE27535 CDE30035 CDE32535 CDE35035 CDE40035
40 CDE15040 CDE20040 CDE22540 CDE25040 CDE27540 CDE30040 CDE32540 CDE35040 CDE40040
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