Medinol Ltd.
Medical device group focused on design, development, clinical evaluation and manufacturing of cardiovascular interventional devices and implantable microsensors. In-house capabilities include materials science, mechanical and analytical testing, process engineering, manufacturing scale-up, regulatory affairs, quality management and global clinical programs.
Industries
Nr. of Employees
large (251-1000)
Patents
Products
EluNIR Ridaforolimus Eluting Coronary Stent System
A coronary drug-eluting stent system utilizing a low metal footprint stent geometry and polymeric drug delivery to release a ridaforolimus analogue.
EluNIR-PERL Drug-Eluting Stent System
Next-generation coronary drug-eluting stent with enhanced radiopaque markers and a hybrid polymer-metal radiopaque catheter tip for improved visibility and deliverability.
IoNIR drug-eluting hybrid scaffold (investigational)
Hybrid scaffold combining a minimal-metal spiral radial component with a polymeric mesh for longitudinal support; incorporates drug into the fiber mesh for uniform delivery.
ChampioNIR drug-eluting peripheral stent (investigational)
Peripheral drug-eluting stent system using a self-expanding Nitinol radial structure combined with a bioresorbable polymeric mesh for flexibility, fracture resistance and full-circumferential drug delivery.
Xemed transcatheter aortic valve replacement (TAVR) system
Modular transcatheter aortic valve replacement device developed for structural heart applications; reported as investigational in first-in-human use.
Microtech implantable microsensors and measurement console
Sub-millimeter passive implantable sensors interrogated via ultrasound and a console/algorithmic system for reconstructing physiological parameters (e.g., intracardiac, intraocular, intracranial pressures).
EluNIR Ridaforolimus Eluting Coronary Stent System
A coronary drug-eluting stent system utilizing a low metal footprint stent geometry and polymeric drug delivery to release a ridaforolimus analogue.
EluNIR-PERL Drug-Eluting Stent System
Next-generation coronary drug-eluting stent with enhanced radiopaque markers and a hybrid polymer-metal radiopaque catheter tip for improved visibility and deliverability.
IoNIR drug-eluting hybrid scaffold (investigational)
Hybrid scaffold combining a minimal-metal spiral radial component with a polymeric mesh for longitudinal support; incorporates drug into the fiber mesh for uniform delivery.
ChampioNIR drug-eluting peripheral stent (investigational)
Peripheral drug-eluting stent system using a self-expanding Nitinol radial structure combined with a bioresorbable polymeric mesh for flexibility, fracture resistance and full-circumferential drug delivery.
Xemed transcatheter aortic valve replacement (TAVR) system
Modular transcatheter aortic valve replacement device developed for structural heart applications; reported as investigational in first-in-human use.
Microtech implantable microsensors and measurement console
Sub-millimeter passive implantable sensors interrogated via ultrasound and a console/algorithmic system for reconstructing physiological parameters (e.g., intracardiac, intraocular, intracranial pressures).
Services
Concept-to-clinic development services including materials selection, mechanical design, coating development, prototyping and preclinical testing.
Contract manufacturing and custom manufacturing solutions for stent production with process qualification and automated equipment support.
Design and conduct of multi-center clinical trials including randomized trials, post-market studies and early feasibility / first-in-human studies.
Regulatory strategy, dossier preparation and quality system implementation aligned with FDA, EU MDR and ISO requirements.
Integration of passive microsensors onto implants and provision of measurement consoles and algorithms for physiologic monitoring.
Concept-to-clinic development services including materials selection, mechanical design, coating development, prototyping and preclinical testing.
Contract manufacturing and custom manufacturing solutions for stent production with process qualification and automated equipment support.
Design and conduct of multi-center clinical trials including randomized trials, post-market studies and early feasibility / first-in-human studies.
Regulatory strategy, dossier preparation and quality system implementation aligned with FDA, EU MDR and ISO requirements.
Integration of passive microsensors onto implants and provision of measurement consoles and algorithms for physiologic monitoring.
Expertise Areas
- Interventional cardiology device development
- Drug-eluting stent engineering
- Implantable microsensor platforms
- Materials science for medical devices
Key Technologies
- Nitinol processing
- Cobalt-chromium (CoCr) alloy device engineering
- Polymeric coating and drug-elution systems
- Passive sub-millimeter implantable sensors
News & Updates
Announcement of FDA approval for the EluNIR-PERL drug-eluting stent for treatment of coronary artery disease and associated U.S. distribution arrangements.
Announcement of CE approval for the EluNIR-PERL DES system, highlighting enhanced visualization features and regulatory clearance for European markets.
Announcement of initiation of human clinical trials and first implantation of a microsensor platform for atrial pressure monitoring in heart failure patients.
Report of successful first-in-human implantation of a hybrid peripheral drug-eluting stent and description of the CHAMPIONSHIP FIH clinical study.
Pooled 5-year clinical outcomes comparing ridaforolimus-eluting and zotarolimus-eluting coronary stents showing similar long-term safety and efficacy.
Journal publication reporting initial results from a first-in-human study of a left atrial pressure microsensor interrogated via ultrasound; ongoing enrollment.
Announcement of FDA approval for the EluNIR-PERL drug-eluting stent for treatment of coronary artery disease and associated U.S. distribution arrangements.
Announcement of CE approval for the EluNIR-PERL DES system, highlighting enhanced visualization features and regulatory clearance for European markets.
Announcement of initiation of human clinical trials and first implantation of a microsensor platform for atrial pressure monitoring in heart failure patients.
Report of successful first-in-human implantation of a hybrid peripheral drug-eluting stent and description of the CHAMPIONSHIP FIH clinical study.
Pooled 5-year clinical outcomes comparing ridaforolimus-eluting and zotarolimus-eluting coronary stents showing similar long-term safety and efficacy.
Journal publication reporting initial results from a first-in-human study of a left atrial pressure microsensor interrogated via ultrasound; ongoing enrollment.