Dutch company Blue Medical has announced CE Mark approval of its Drug Eluting Balloon (DEB) and accompanying CoCr (Cobalt Chromium) coronary stent. The new system uses the company’s Pioneer bare metal technology and the Protégé balloon, which delivers an immunosuppressive therapy to the coronary artery. Blue Medical claims that this combination allows their system to effectively prevent re-occlusion of the artery while also reducing some of the long term side effects associated with drug eluting stents. The company plans to make their system available in Europe by the end of this year.
Some technical specs of the DEB delivery system:
Nominal pressure: 11 bar Rated Burst Pressure: 18 bar (except Ø 4.0 = 15 bar) Balloon folds: 3-folds; Wing-Seal Technology Balloon material: Semi-compliant polyamide for controlled dimensions Drug: Paclitaxel (3.0 µg/mm2, Drug loaded balloon surface) Guiding catheter compatibility: 5F (min ID 0.056″) Guide wire compatibility: Max 0.014″ Catheter type: Rapid Exchange Proximal shaft: 1.9F (0.64 mm) Tip: Short, thin and soft 3 mm tip Distal shaft: 2.4F (0.80 mm) Average crossing profile 1.0 – 1.1 mm (0.039″ – 0.043″) Lesion entry profile: 0.016″ (0.40 mm) Catheter coating: Hydrophilic coating