title: A novel constrained, paclitaxel-coated angioplasty balloon catheter.
abstract: OBJECTIVE
  The study aimed to assess drug adherence, transfer to the vessel wall, tolerance and efficacy of a constrained angioplasty balloon coated with an excipient-enhanced paclitaxel coating (Chocolate coated balloon [CCB]) in the porcine model.
  
  
  RESULTS
  Drug adherence was investigated in vitro. Drug transfer was evaluated in porcine arteries. A stent overstretch model was chosen to provoke intimal thickening in the efficacy and tolerance study. Conventional uncoated balloons were used as controls. CCB were coated with a nominal (3 µg/mm2) and high dose (two completely overlapping inflations each at 6 µg/mm2) of paclitaxel. Efficacy was assessed by histomorphometry and quantitative coronary angiography (QCA). Tolerance, including potential downstream effects, was assessed by myocardial function and histopathology. The CCB lost 6±12% of dose during in vitro simulated delivery to the lesion; drug transfer to the vessel wall was 14±4%. QCA and histomorphometry revealed no baseline differences between treatment groups. Thirty days after treatment, both doses of the CCB resulted in a 50% reduction in neointimal thickening of arteries relative to the uncoated balloon group. Maximum neointimal thickness was 1.12±0.36 mm for uncoated control specimens and 0.46±0.06 mm and 0.44±0.30 mm for the two CCB doses (3 and 2×6 µg/mm2), respectively. There were no device-related animal deaths or changes in left ventricular ejection fraction or device-specific myocardial histopathologies. There were no statistically significant differences between inflammatory scores among treatment groups.
  
  
  CONCLUSIONS
  The results demonstrate efficacy and tolerance of a mechanically unique constrained angioplasty balloon within the tested dose range of the selected paclitaxel coating in the chosen porcine preclinical model.
authors.affiliation: Universitaetsklinikum des Saarlandes, Homburg/Saar, Germany.
authors.forename: Bodo
authors.initials: B
authors.lastname: Cremers
authors.forename: Gary
authors.initials: G
authors.lastname: Binyamin
authors.forename: Yvonne P
authors.initials: YP
authors.lastname: Clever
authors.forename: Paul
authors.initials: P
authors.lastname: Seifert
authors.forename: Eitan
authors.initials: E
authors.lastname: Konstantino
authors.forename: Bettina
authors.initials: B
authors.lastname: Kelsch
authors.forename: Stephanie
authors.initials: S
authors.lastname: Bienek
authors.forename: Ulrich
authors.initials: U
authors.lastname: Speck
authors.forename: Bruno
authors.initials: B
authors.lastname: Scheller
mesh_terms: D000497:Alloys; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D000818:Animals; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000493:pharmacokinetics; D008297:Male; D058426:Neointima / Q000517:prevention & control*; D017239:Paclitaxel / Q000008:administration & dosage* / Q000493:pharmacokinetics; D013552:Swine
chemical_list: D000497:Alloys; D000972:Antineoplastic Agents, Phytogenic; C013616:nitinol; D017239:Paclitaxel