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Mechanical Properties of Percutaneous Transluminal Coronary Angioplasty Balloon Catheters: A Bench Study
C Amstutz1, M Hersberger2, N Fontaine2
1School of Biomedical and Precision Engineering, University of Bern, Bern, Switzerland. Cornelia.Amstutz@unibe.ch.
Purpose:
This paper aims to categorize the mechanical properties of eight percutaneous transluminal coronary angioplasty (PTCA) balloon catheters and translate them into clinical needs.
Method:
Objective bench tests quantified PTCA balloon catheters' mechanical properties, including tensile strength, kink resistance, bending, torsional behavior, friction, radio-opacity, pushability, and trackability. The results were compared against each other and supplemented by a survey of interventional cardiologists.
Results:
Clinical needs with respect to deliverability, dilatation efficiency, and crossability were assessed for each catheter. Results indicate that SC Maverick2 excels in deliverability and crossability but lags in dilatation efficiency compared to NC catheters, though it is rated best to fulfill clinical needs. SC EasyT outperforms Maverick2 in dilatation efficiency but has inferior deliverability, similar to NC catheters. The NC balloons were comparable. However, Accuforce exhibits highest deliverability, Pantera LEO shows superior dilatation efficiency, NC Emerge shows best crossability, and Sapphire NC24 exhibits lowest performance. According to the survey, Accuforce, Sapphire NC24, and NC Trek are favored over NC Emerge and Pantera LEO. OPN NC offers limited deliverability but can treat lesions where standard NC catheters fail due to its unique rated burst pressure. Trackability and pushability estimates align better with survey results than those obtained from simulated use-case tests, except for Sapphire NC24 and OPN NC. Torquability measurements show discrepancies with survey ratings, indicating additional influences and rating challenges.
Conclusion:
Our study comprehensively analyzes PTCA balloon catheters, emphasizing the importance of integrating mechanical and design attributes throughout development. Performance properties like trackability and pushability were measured, providing unbiased insights for comparison independent of individual practitioner preferences.
