Background: Eight commercially available percutaneous transluminal coronary angioplasty (PTCA), including semi-compliant and non-compliant balloons, have been assessed in detail on their tip, balloon, shaft, RX-Port, and hypotube design. Important performance characteristics such as tip deformation, balloon elongation, and deflation rate have been quantified. Methods: Five catheters of each model were evaluated during various tests. The robustness of the tips was evaluated through compression, measuring any occurrence of damage. The longitudinal growth of the balloons was recorded during inflation up to Rated Burst Pressure (RBP). The forces required to move the catheter forward and retract it into the guide catheter were measured in a simulated use test setup. The deflation behavior was studied by measuring extracted contrast media over time. Furthermore, balloon compliance and catheter dimensions were investigated. Results: The outer dimensions of the catheter were found to be smallest at the hypotube (0.59–0.69 mm) and highest at the balloon, respectively, the crossing profile (0.9–1.2 mm). The tip diameter increased after compression by 1.7–22%. Cross-sections of the folded balloons revealed a tri- and two-fold, respectively. The measured balloon elongation ranged from 0.6 to 2.0 mm. After the inflation of the balloon, an increase in friction between the guide wire and the catheter was observed on four catheters. A maximum increase of 0.12 N to 1.07 N was found. Cross-sections of the RX-Port revealed a semicircular-shaped inflation lumen and a circular guide wire lumen. The measured deflation rate ranged from 0.004 to 0.013 µL/s, resulting in an estimated balloon deflation time of 10.2–28.1 s. Conclusion: This study provides valuable insights into the design characteristics of RX PTCA balloon catheters, which can contribute to facilitating the development of improved catheter designs and enhancing clinical outcomes. Distinctions between SC and NC catheters, such as balloon performance and dimensions, are evident. It is important to note that no single catheter excels in all aspects, as each possesses unique strengths. Therefore, it is essential to consider individual intervention requirements when selecting a catheter. The research also identifies specific catheter weaknesses, such as reduced wall thickness, fringes at the tip, and reduced performance characteristics.

Small-dimeter blood vessels (<6 mm) are required in coronary bypass and peripheral bypass surgery to circumvent blocked arteries. However, they have poor patency rates due to thrombus formation, intimal hyperplasia at the distal anastomosis, and compliance mismatch between the native artery and the graft. This review covers the state-of-the-art technologies for improving graft patency with a focus on reducing compliance mismatch between the prosthesis and the native artery. The focus of this article is on biomimetic design strategies to match the compliance over a wide pressure range.

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.