Devoir is a first generation sirolimus coated balloon catheter that combines bio-sphere coating technology with the established anti-proliferative and cytostatic properties of sirolimus. Bio-sphere coating technology incorporates a phospholipid bilayer designed to minimise in-transit drug loss and provide fast and efficient drug transfer to the arterial wall.

SPECIFICATION

• Drug and dose:  sirolimus coated (1.27 μg/mm² )
• Drug carrier:  bio-sphere technology.
• Balloon material: polyamide blend (semi compliant)
• Catheter design: rapid exchange
• Shaft diameter: proximal (1.7F), Distal (2.5F)
• Usable catheter length: 140cm
• Tip Profile: 0.016″
• Nominal pressure: 6 bar
• Rated Burst Pressure: 16 bar (14 bar for 4.00 / 25 – 40mm)
• Guidewire catheter compatibility: 5F (0.056″ ID) for all sizes
• Guidewire compatibility: 0.014″ maximum recommended

CLINICAL DATA

A prospective, multi-centre clinical registry is ongoing.  The registry seeks to evaluate safety and performance of the Devoir Sirolimus Coated Balloon for the treatment of lesions in native coronary arteries, with vessel diameters of 1.5 – 4.0mm.  The 12 months cumulative clinical results (323 patients, 428 lesions) are listed below:

• MACE: 4.3%
• Cardiac death: 0.3%
• TLR/TVR: 3.7%
• MI: 0.3%