Bridgepoint Medical Mantaray Tm Catheter
Bridgepoint Medical
FDA Clearance Information
The Bridgepoint Medical Mantaray TM Catheter was cleared through the FDA 510k pathway on August 10, 2011. It is manufactured by Bridgepoint Medical and classified as a Class 2 device under product code DQY.
What It Is
FDA-Cleared Indications
- Facilitation of stent placement in the venous system during percutaneous endovascular procedures.
Clinical Applications
- Catheter-based delivery and placement of stents in veins.
- Endovascular treatment of venous obstruction when a venous stent is indicated.
- Stent placement in the iliac or central venous system when the anatomy and treatment plan are appropriate.
Practical Considerations
- The specific catheter size and configuration should be selected for the target vessel, access route, guidewire, and stent system.
- Use requires fluoroscopic or other appropriate imaging guidance and clinicians trained in percutaneous venous intervention.
- Confirm compatibility with the intended guidewire, sheath, contrast medium, and venous stent before the procedure.
- The FDA record provided does not establish an MRI safety designation; consult the current device labeling before MRI examination.
- Contraindications, warnings, storage requirements, and handling instructions should be taken from the current manufacturer labeling. General risks include bleeding, vascular injury, infection, thrombosis, embolization, and contrast-related reactions.
Procedures that use this device
Linked Studies (14)
Efficacy, safety, and complications of manta vascular closure device in VA-ECMO decannulation: A systematic review and meta-analysis.
The journal of vascular access
RCT|prospective|retrospective|case Series|other View Source →[The MANTA Vascular Closure Device in transfemoral TAVI: a real-world cohort].
REC, interventional cardiology
RCT|prospective|retrospective|case Series|other View Source →Alternative Application Technique for the MANTA Vascular Closure Device for Percutaneous Large-Bore Arterial Access Closure: The Fluoroscopic DOT Technique.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →Outcomes with plug-based versus suture-based vascular closure device after transfemoral transcatheter aortic valve replacement: A systematic review and meta-analysis.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
RCT|prospective|retrospective|case Series|other View Source →Percutaneous decannulation of venoarterial extracorporeal membrane oxygenation using the Manta vascular closure device: A systematic review and meta-analysis.
Artificial organs
RCT|prospective|retrospective|case Series|other View Source →Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI.
The Thoracic and cardiovascular surgeon
RCT|prospective|retrospective|case Series|other View Source →The MANTA Vascular Closure Device: Requiring Attention From Beginning to End, Reply.
Cardiovascular revascularization medicine : including molecular interventions
View Source →Ultrasound-Guided Versus Conventional MANTA Vascular Closure Device Deployment After Transcatheter Aortic Valve Implantation.
The American journal of cardiology
View Source →Amantadine treatment is associated with improved consciousness in patients with non-traumatic brain injury.
Journal of neurology, neurosurgery, and psychiatry
RCT|prospective|retrospective|case Series|other View Source →The MANTA Vascular Closure Device for Percutaneous Femoral Vessel Cannulation in Minimally Invasive Surgical Mitral Valve Repair.
Innovations (Philadelphia, Pa.)
RCT|prospective|retrospective|case Series|other View Source →Safety and Effectiveness of MANTA Vascular Closure Device After Large-Bore Mechanical Circulatory Support: Real-World Experience.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →First Experiences with MANTA Vascular Closure Device in Minimally Invasive Valve Surgery.
The Thoracic and cardiovascular surgeon
RCT|prospective|retrospective|case Series|other View Source →Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
View Source →Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
View Source →Frequently Asked Questions
What is the Bridgepoint Medical Mantaray TM Catheter used for?
It is used to facilitate the placement of stents in the venous system, particularly in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons are the primary users of this device.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of stents within the venous system to address blockages or structural issues.