Cleverballoon: An integrated approach for developing a drug-coated balloon with everolimus

Area of Science:

• Cardiovascular Medicine
• Biomaterials Science
• Medical Device Engineering

Background:

• Coronary artery disease (CAD) poses significant mortality and morbidity risks.
• Drug-eluting stents are common, but drug-coated balloons (DCBs) offer an alternative, particularly for specific vascular conditions.
• DCBs facilitate rapid, uniform drug delivery to the arterial wall during inflation.

Purpose of the Study:

• To present an integrated approach for the design and development of an innovative drug-coated balloon (DCB) utilizing everolimus.
• To optimize DCB performance by combining in vivo, in vitro, and in silico methodologies.
• To align the development process with the 3Rs principles (Replacement, Reduction, Refinement) for animal and clinical studies.

Main Methods:

• Development of a novel DCB incorporating everolimus.
• Utilization of in vivo studies to assess performance in a biological context.
• Application of in vitro testing for controlled evaluation of DCB characteristics.
• Implementation of in silico modeling for predictive analysis and optimization of DCB design.
• Integration of all three approaches to refine the DCB development process.

Main Results:

• The study presents a comprehensive methodology for DCB development.
• The integrated approach allows for systematic optimization of DCB design parameters.
• The methodology adheres to ethical principles by minimizing animal and clinical testing.

Conclusions:

• An integrated in vivo, in vitro, and in silico approach is effective for developing innovative drug-coated balloons.
• This integrated strategy enhances the optimization process for DCBs, such as the novel everolimus-eluting DCB.
• The presented methodology supports the 3Rs principles, paving the way for more efficient and ethical medical device development.