Paving the way to a bioresorbable technology: Development of the absorb BRS program

Area of Science:

• Cardiovascular Devices
• Biomaterials Engineering
• Interventional Cardiology

Background:

• Bioresorbable scaffolds (BRS) represent the fourth generation of percutaneous coronary intervention (PCI) devices.
• They integrate features of previous generations with novel technologies for improved treatment.
• BRS aim to combine the benefits of drug-eluting stents with the long-term effects of balloon angioplasty.

Purpose of the Study:

• To review the fundamental principles of bioresorbable scaffold operation.
• To discuss the three key phases of BRS functionality: revascularization, restoration, and resorption.
• To outline the metrics for nonclinical evaluation of BRS, including bench and preclinical testing.

Main Methods:

• This review discusses the operational principles of BRS, applicable to both polymeric and metallic compositions.
• It focuses on the physiological requirements and functional transitions over time.
• Evaluation metrics for bench and preclinical testing are presented.

Main Results:

• BRS provide initial mechanical support and drug elution to prevent restenosis, similar to drug-eluting stents.
• Scaffold degradation leads to a gradual decrease in radial strength.
• This allows for a transition of mechanical function back to the native artery, mimicking balloon angioplasty outcomes.

Conclusions:

• BRS operate through three distinct phases: revascularization, restoration, and resorption.
• Understanding these phases is crucial for evaluating BRS performance.
• Standardized nonclinical testing is essential for assessing the efficacy and safety of these novel PCI devices.