Clinical Review of the CATHTRONIX Intravascular Hydrophilic Guide Wire: Clinical Outcomes Evaluation with Hospital-Based Clinical Follow-Up and State-of-the-Art Literature Appraisal

Abstract

Background and Objective: Guide wires are fundamental enabling devices in contemporary endovascular medicine and constitute an essential component of diagnostic and therapeutic procedures performed within the coronary, peripheral, and neurovascular systems. Their primary role is to establish and maintain intravascular access, facilitate navigation through complex vascular anatomy, cross stenotic or occluded lesions, and provide support for the delivery, positioning, and exchange of compatible diagnostic and interventional devices. Consequently, guide wire performance is a critical determinant of procedural success, procedural efficiency, device deliverability, and overall patient safety. . This clinical evaluation was conducted for the CATHTRONIX Intravascular Hydrophilic Guide Wire to establish its clinical safety, clinical performance and clinical benefit and to demonstrate compliance with Regulation (EU) 2017/745 (MDR). Hydrophilic guide wires have become widely adopted across multiple vascular specialties due to their enhanced lubricity and reduced frictional resistance, which facilitate advancement through tortuous vessels, complex lesions, and challenging anatomical pathways. The combination of optimized core-wire design, torque transmission characteristics, flexibility, support, tip configuration, and hydrophilic coating technology allows these devices to provide effective navigation while minimizing vessel trauma and reducing procedural complexity. In addition, radiopaque components incorporated into the distal section of the guide wire enable accurate fluoroscopic visualization, thereby supporting procedural precision and operator control. The CATHTRONIX Intravascular Hydrophilic Guide Wire is intended for use within the coronary, peripheral, and neurovascular vasculature to facilitate the placement, exchange, and support of compatible catheters and other intravascular devices during diagnostic and interventional procedures. The device consists of a fixed-core guide wire incorporating stainless steel and/or nitinol components, hydrophilic polymer-coated and PTFE-coated sections, a lubricious distal working segment, and radiopaque elements designed to enhance visibility during fluoroscopic guidance. Upon exposure to sterile saline or heparinized saline, the hydrophilic coating becomes highly lubricious, reducing friction between the guide wire, vascular structures, and compatible devices, thereby facilitating controlled intravascular navigation and device delivery. This Clinical Evaluation was conducted in accordance with the requirements of Regulation (EU) 2017/745 on Medical Devices (MDR), relevant MDCG guidance documents, and internationally recognized principles for clinical evaluation. The purpose of the evaluation was to systematically identify, appraise, and analyze the available clinical evidence relating to the CATHTRONIX Intravascular Hydrophilic Guide Wire and to determine whether sufficient clinical evidence exists to support its intended purpose and intended use. The primary objective of the evaluation was to establish and document adequate clinical evidence demonstrating the clinical safety, clinical performance, and clinical benefits of the device throughout its intended clinical applications. Specifically, the evaluation aimed to confirm that the device:  Facilitates safe and effective intravascular access, navigation, lesion crossing, and device delivery within the coronary, peripheral, and neurovascular systems.  Demonstrates satisfactory performance characteristics, including trackability, steerability, torque transmission, flexibility, supportability, pushability, and compatibility with intended accessory devices.  Maintains mechanical integrity and functional performance throughout clinical use without unacceptable risk of fracture, tip detachment, coating degradation, kinking, loss of torque control, or other device-related failures.  Supports the successful completion of diagnostic and interventional procedures by enabling accurate placement and exchange of compatible intravascular devices.  Maintains an acceptable safety profile with respect to device-related and procedure-related adverse events.  Provides clinically meaningful benefits that outweigh the residual risks associated with its intended use. Furthermore, the evaluation sought to verify conformity with the applicable General Safety and Performance Requirements (GSPRs) of Regulation (EU) 2017/745 through a comprehensive assessment of device-specific clinical data, relevant scientific literature, equivalent-device evidence where applicable, risk management documentation, post-market surveillance information, and other relevant clinical evidence sources. The totality of the evidence was integrated using a weight-of-evidence approach to determine whether the CATHTRONIX Intravascular Hydrophilic Guide Wire performs as intended, achieves its intended clinical benefits, and maintains a favorable benefit-risk profile consistent with the current state of the art in endovascular guide wire technology. Methods: A hospital-based clinical follow-up of 50 consecutive cases was conducted across coronary, peripheral and neurovascular procedures, evaluating device deliverability, lubricity, trackability, torque response, tip-shape retention, radiopacity, support for device exchange, procedural success and safety. Device-specific evidence was integrated, using a weight-of-evidence approach, with a large state-of-the-art comparator: a 7,575-case analysis of polymerjacketed (hydrophilic) versus non-polymer-jacketed wires in antegrade chronic total occlusion (CTO) percutaneous coronary intervention from the PROGRESS-CTO registry (Alexandrou et al., 2024). Clinical evidence for the CATHTRONIX Intravascular Hydrophilic Guide Wire was established through a comprehensive clinical evaluation process conducted in accordance with Regulation (EU) 2017/745 (MDR), MEDDEV 2.7/1 Revision 4 principles, relevant MDCG guidance documents, and applicable international standards governing the clinical evaluation of medical devices. The evaluation adopted a systematic weight-of-evidence methodology to ensure that all relevant clinical, technical, and post-market information was critically appraised and integrated to support conclusions regarding clinical safety, clinical performance, clinical benefit, and overall benefitrisk acceptability. The primary source of device-specific clinical evidence was a hospital-based clinical follow-up investigation involving 50 consecutive patients undergoing coronary, peripheral, and neurovascular diagnostic or interventional procedures in which the CATHTRONIX Intravascular Hydrophilic Guide Wire was used under routine clinical conditions. Consecutive patient enrollment was employed to minimize selection bias and to ensure that the collected data reflected real-world clinical practice across the intended vascular territories and intended clinical applications of the device. The clinical follow-up evaluated the guide wire throughout all stages of procedural use, including vascular navigation, lesion crossing, device support, device exchange, and procedural completion. Particular attention was given to key performance characteristics that directly influence the effectiveness and safety of guide wire technology. These included:  Guide wire deliverability through introducers, catheters, and vascular anatomy.  Trackability and navigational performance within tortuous or complex vascular pathways.  Lesion-crossing capability where clinically applicable.  Torque transmission and steering response during manipulation.  Hydrophilic coating performance and lubricity during advancement and retrieval.  Tip flexibility, tip-shape retention, and controllability.  Radiopacity and fluoroscopic visibility.  Support characteristics for advancement, placement, and exchange of compatible intravascular devices.  Resistance to kinking, deformation, or loss of mechanical integrity during use.  Overall procedural success attributable to guide wire performance. Results: Technical success was achieved in 50/50 cases (100%), with adequate device support and successful catheter placement/exchange in every case. All 50 cases were accepted with optimum clinical outcomes and no device-related serious adverse events, wire fractures, coating delamination, vessel perforations or tip deformations. These outcomes are concordant with and supported by the equivalent-device literature, in which exclusive use of hydrophilic polymerjacketed wires was independently associated with higher technical success (94.3% vs 85.7%; adjusted OR 2.66, 95% CI 2.13–3.36, p<0.001) and lower perforation risk (2.2% vs 3.2%; adjusted OR 0.69, 95% CI 0.49–0.95, p=0.02). The hospital-based clinical follow-up investigation demonstrated excellent clinical performance and a favorable safety profile for the CATHTRONIX Intravascular Hydrophilic Guide Wire across a diverse range of coronary, peripheral, and neurovascular procedures. The device consistently fulfilled its intended function of facilitating intravascular access, vascular navigation, lesion crossing where applicable, and the delivery and exchange of compatible diagnostic and therapeutic devices. Technical success was achieved in all evaluated cases (50/50; 100%). In every procedure, the guide wire was successfully advanced to the intended target location and provided adequate support for the delivery, placement, manipulation, and exchange of compatible intravascular devices. Successful completion of the intended diagnostic or interventional procedure was achieved in all cases without the need for guide wire replacement attributable to performance deficiencies or device failure. Assessment of device performance characteristics demonstrated satisfactory deliverability, lubricity, trackability, torque transmission, tip controllability, radiopacity, and supportability throughout clinical use. The hydrophilic coating