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Balloon coating with rapamycin using an on-site coating device.

Jörg Schmehl1, Jürgen von der Ruhr, Markus Dobratz

  • 1Department of Diagnostic and Interventional Radiology, University Hospital of Tübingen, Hoppe-Seyler-Str. 3, 72076 Tübingen, Germany. joerg.schmehl@med.uni-tuebingen.de

Cardiovascular and Interventional Radiology
|February 26, 2013
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Summary

This study explored rapamycin-eluting balloons as an alternative to paclitaxel. While feasible, the rapamycin balloon coating showed moderate biological effects, necessitating further optimization for improved efficacy in vascular interventions.

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Area of Science:

  • Cardiovascular medicine
  • Biomaterials science
  • Interventional cardiology

Background:

  • Drug-eluting balloons (DEBs) are established for vascular interventions.
  • Paclitaxel is the primary drug used in DEBs due to its properties.
  • There is a need for alternative DEB coatings for improved clinical outcomes.

Purpose of the Study:

  • To evaluate the feasibility and efficacy of a novel balloon coating using rapamycin.
  • To assess rapamycin delivery to the vessel wall using a site-applied coating.
  • To investigate the biological impact of rapamycin-eluting balloons in a preclinical model.

Main Methods:

  • Rapamycin coating of balloons (3.0/18 and 3.0/12 mm) with varying concentrations (2-4%).
  • Quantification of rapamycin on the balloon and release into the vessel wall via spectroscopy.
  • Evaluation of biological effects in a porcine peripheral overstretch and stent implantation model.

Main Results:

  • Rapamycin amounts on the balloon ranged from 558 ± 108 μg to 1,441 ± 228 μg.
  • Vessel wall delivery of rapamycin was measured between 95 ± 63 μg and 193 ± 113 μg.
  • A reduction in diameter stenosis from 20.6 ± 17.4% (control) to 11.6 ± 5.5% was observed in the rapamycin DEB group.

Conclusions:

  • Site-applied rapamycin balloon coating is feasible using a dose-adjustable machine.
  • The current rapamycin coating demonstrated moderate biological effects.
  • Further optimization of the coating process and excipients is required for enhanced efficacy.