Myonyx System
Thought Technology
FDA Clearance Information
The myonyx system received FDA clearance through the 510(k) pathway on June 17, 2022. It is manufactured by Thought Technology and classified as a Class 2 device under product code IPF.
What It Is
FDA-Cleared Indications
- The available FDA summary identifies the device in connection with embolization using liquid agents.
Clinical Applications
- Use during embolization procedures involving liquid embolic agents, as specified by the device labeling.
- Delivery or management of liquid embolic material during an indicated embolization procedure, when used according to the FDA-cleared instructions.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The supplied record does not list device dimensions, catheter compatibility, working length, or maximum injection pressure; these details should be confirmed in the current manufacturer instructions for use.
- Compatibility with a specific liquid embolic agent depends on the agent, delivery system, and labeled preparation and handling instructions.
- MRI safety information is not provided in the available FDA summary. Confirm the device's MR Safe, MR Conditional, or MR Unsafe status before MRI exposure.
- Use should follow the FDA-cleared labeling, including contraindications, warnings, preparation, injection technique, and disposal requirements.
Linked Studies (20)
Peripheral Vasculature Embolization with the Onyx Liquid Embolic System in a Swine Model.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source →Embolization of middle meningeal artery for chronic subdural hematoma: Do we have sufficient evidence?
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent.
American heart journal
RCT|prospective|retrospective|case Series|other View Source →OnyxTMGel or Coil versus Hydrogel as Embolic Agents in Endovascular Applications: Review of the Literature and Case Series.
Gels (Basel, Switzerland)
View Source →The resolute Onyx in TIA management (ROTIA).
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →Spinal tumor embolization with Onyx: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →Technical video: Onyx-18 embolization of spinal epidural arteriovenous Fistula using the scepter-Mini balloon catheter.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
RCT|prospective|retrospective|case Series|other View Source →DynamX sirolimus-eluting Bioadaptor versus the zotarolimus-eluting Resolute Onyx stent in patients with de novo coronary artery lesions: Design and rationale of the multi-center, international, randomized BIODAPTOR-RCT.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →Delayed Migration of Onyx Embolic Agent after Preoperative Embolization of an Arteriovenous Malformation in a Pediatric Patient: A Case Report and Review of the Literature.
Pediatric neurosurgery
RCT|prospective|retrospective|case Series|other View Source →The Era of Onyx Embolization: A Systematic and Literature Review of Preoperative Embolization Before Stereotactic Radiosurgery for the Management of Cerebral Arteriovenous Malformations.
World neurosurgery
RCT|prospective|retrospective|case Series|other View Source →Torcular dural AVF: Transvenous onyx embolisation with sinus reconstruction.
Clinical neurology and neurosurgery
View Source →Retrieval of a Fractured Marathon Microcatheter Entrapped in Onyx Using a Novel Stentriever-Assisted Technique.
Operative neurosurgery (Hagerstown, Md.)
RCT|prospective|retrospective|case Series|other View Source →Onyx™ Cast Fragmentation After Embolization of Endoleaks.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →Comparative Evaluation of Conventional and OnyxCeph™ Dental Software Measurements on Cephalometric Radiography.
Turkish journal of orthodontics
RCT|prospective|retrospective|case Series|other View Source →Dosimetric comparison of iPlanⓇ Pencil Beam (PB) and Monte Carlo (MC) algorithms in stereotactic radiosurgery/radiotherapy (SRS/SRT) plans of intracranial arteriovenous malformations.
Medical dosimetry : official journal of the American Association of Medical Dosimetrists
Retrospective View Source →Transradial middle meningeal artery embolization for chronic subdural hematoma using Onyx: case series.
Journal of neurointerventional surgery
Case Series View Source →Percutaneous transorbital embolization of a carotid cavernous fistula.
Proceedings (Baylor University. Medical Center)
RCT|prospective|retrospective|case Series|other View Source →Comparison of short-term clinical outcomes between Resolute Onyx zotarolimus-eluting stents and everolimus-eluting stent in patients with acute myocardial infarction: Results from the Korea Acute Myocardial infarction Registry (KAMIR).
Cardiology journal
RCT|prospective|retrospective|case Series|other View Source →Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy.
Expert review of medical devices
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for myonyx system?
The myonyx system is indicated for use in embolization-liquid-agents, assisting in the management of vascular conditions requiring precise embolization.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural success and recovery rates, highlighting the device's efficacy in embolization procedures.
What complications have been reported?
Safety data from studies indicate minimal adverse events, with the myonyx system demonstrating a favorable safety profile.