A novel fiber‐optic based 0.014″ pressure wire: Designs of the OptoWire™, development phases, and the O₂ first‐in‐man results

Abstract

Objectives: To review the technical limitations of available pressure-wires, present the design evolution of a nitinol fiber-optic pressure wire and to summarize the Firstin-Man (FIM) O 2 pilot study results.Background: Despite increasing use of physiology assessment of coronary lesions, several technical limitations persist. We present technical details, design evolution and early clinical results with a novel 0.014" nitinol fiber-optic based pressure-wire.Methods and Results: The 0.014' OptoWire™ (Opsens Medical, Quebec, Canada) was designed to combine improved handling properties compared to standard pressure-wires and to offer extremely reliable pressure recording and transmission due to fiber-optic properties compared to piezo-electric sensors and electrical wires. In vitro assessment showed that OptoWire™ steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First-in-Man O 2 study, 60 patients were recruited at 2 centers in Canada. A total of 103 lesions were assessed with the OptoWire™ and OptoMonitor™, 75 lesions at baseline and 28 lesions post-PCI (without disconnection). In all crossed lesions (n = 100, 97%), mean Pd/Pa and FFR could be adequately measured. In 11 cases assessed successively with OptoWire™ and Aegis™ (Abbott Vascular, USA) bland-Altman analysis showed a mean difference of 0.002 ± 0.052 mmHg (p = .91) for Pd/Pa and 0.01 ± 0.06 for FFR calculation (p = .45). There was no device-related complication. Upon these initial results, several design changes aimed to improve overall performance including torquability, stiffness, resistance to kink and pressure drift were completed. Conclusion:The novel 0.014" fiber-optic OptoWire™ provides superior wire handling with reduced risk of pressure drift allowing reliable pre-and post-PCI physiology assessment.

Recent Progress in MEMS Fiber-Optic Fabry–Perot Pressure Sensors

“…Fiber-optic-based pressure sensors have not only anti-interference ability, high precision, flexibility, and ease of bending, but are also corrosion-resistant, which well meets the above needs. As it becomes an alternative to electro-mechanical pressure sensors, the optical fiber pressure sensor has become increasingly common in the medical field [ 28 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 ].…”

“…Omori et al [ 86 ] investigated FFR measurement, as shown in Figure 9 . In 2020, Ulacia et al [ 87 ] finished the First-in-Man O 2 pilot study.…”

Fractional flow reserve and non-hyperemic indices: Essential tools for percutaneous coronary interventions

“…Therefore, the NAVVUS RXi ® and the TruePhysio™ are microcatheters to be used with any workhorse wire to overcome these issues, with debatable opinions. In vitro assessment of the novel 0.014’’ OptoWire™ showed improved pushability, steerability and torquability in comparison with regular PCI wires, offering reliable pre and post PCI hemodynamic assessment[ 35 ].…”

Modified Surface Composition and Biocompatibility of Core-Shell Nitinol Nanoparticles Fabricated via Laser Ablation of Differently Passivized Targets

“…Shape memory effects have been observed during austenite to martensite transformation, i.e., transformation from the face-centered cubic (FCC) structure to a body-centered tetragonal (BCT) structure (Parmar et al, 2021). Nitinol has gained popularity in the biomedical field, given its corrosion resistance, acceptable biocompatibility, super-elasticity, osseointegration, and fatigue and kink resistance properties (Hamann et al, 2020;Ulacia et al, 2020). The alloy has applications in the biomedical field as coronary stents, dental archwires, and actuators, although the concerns of nickel leaching limit the application (Fouladian et al, 2021).…”

“…For the purpose of biomedical applications, it is important to prepare stable monodispersed solutions with NPs possessing less aggregation propensity (Phan and Haes, 2019). The exposure of NPs in a physiological environment leads to absorption of biological substances (proteins, lipids, peptides, nucleic acids, metabolites, and others) onto the surface of the NPs, leading to the formation of biocorona (Shannahan, 2017;Ulacia et al, 2020). The biocorona presents a unique challenge for the practical and safe biomedical application by affecting the toxicity, functionality, and characteristics of NPs and thereby altering thrombogenic properties as well (Chakraborty et al, 2019;Sena et al, 2020).…”