Manta Vascular Closure Device
Teleflex Medical
Product: Manta — all models and sizes
FDA Clearance Information
The Manta Vascular Closure Device was cleared by the FDA through the PMA pathway on May 26, 2020. It is manufactured by Teleflex Medical and classified as a Class 3 device.
What It Is
FDA-Cleared Indications
- The supplied FDA indication text states: "Implementation of an automated tray component packaging inspection process."
- The provided FDA record does not include a clinical indication for vascular access-site closure.
Clinical Applications
Reported off-label uses
- Closure of large-bore common femoral arterial access sites after procedures such as transfemoral transcatheter aortic valve implantation or replacement.
- Closure during or after removal of large-bore femoral arterial cannulas used for temporary mechanical circulatory support, including VA-ECMO.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The device is intended for large-bore femoral arterial access and requires appropriate vessel anatomy, including adequate vessel diameter and access-site location.
- Use requires imaging or angiographic assessment of the access vessel and confirmation that the puncture is suitable for closure.
- Available device configurations include different sheath or access sizes; the selected size must match the procedural access system and labeling.
- Important concerns include femoral artery occlusion, bleeding, hematoma, infection, distal ischemia, pseudoaneurysm and failure of hemostasis.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling and FDA documentation before MRI.
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 are the clinical indications for Manta Vascular Closure Device?
The device is indicated for closing large-bore arterial access sites, particularly in procedures like VA-ECMO decannulation and transfemoral TAVI.
What outcomes have been reported in clinical studies?
Studies report high success rates in achieving hemostasis and reducing procedural complications such as bleeding and infection.
What complications have been reported?
Reported complications include bleeding, hematoma formation, and device failure, though these are less frequent compared to surgical methods.