📊 Evidence-Based Reference

manta vascular closure device

Teleflex Medical

Summary: The Manta Vascular Closure Device is used for large-bore arterial access closure, primarily in procedures like VA-ECMO decannulation and TF-TAVI. Key evidence highlights its efficacy in reducing procedural complications.

FDA Clearance Information

Pathway PMA
Decision Date May 26, 2020
Product Code MGB
Device Class Class 3
Evidence 14 studies

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

The Manta Vascular Closure Device is designed for closing large-bore arterial access sites. It uses an intraluminal foot plate and an extraluminal collagen plug to achieve hemostasis, intended for use in percutaneous procedures.

Clinical Applications

Commonly used in procedures requiring large-bore arterial access such as VA-ECMO decannulation and transfemoral TAVI. It provides a percutaneous alternative to surgical closure, reducing recovery time and complications.

Evidence Summary

The literature includes 15 studies, encompassing RCTs, prospective, and retrospective analyses, published between 2023 and 2026. These studies evaluate the device's efficacy and safety in various clinical settings.

Reported Outcomes

Published studies report that the Manta Vascular Closure Device effectively reduces procedural complications such as bleeding and infection in VA-ECMO decannulation and TF-TAVI. It is associated with high success rates in achieving hemostasis and reducing patient recovery time.

Safety Profile

Reported complications include bleeding, hematoma formation, and device failure, though these are less frequent compared to surgical closure methods. The device's safety profile is generally favorable in the reviewed studies.

Evidence Limitations

Current evidence is limited by the variability in study designs and patient populations. Further research is needed to establish long-term outcomes and to compare the device directly with other closure methods.

Linked Studies (14)

PubMed • 2026

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 →
PubMed • 2025

[The MANTA Vascular Closure Device in transfemoral TAVI: a real-world cohort].

REC, interventional cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2023

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 →
PubMed • 2023

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 →
PubMed • 2023

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 →
PubMed • 2023

Evaluation of the MANTA Vascular Closure Device in Transfemoral TAVI.

The Thoracic and cardiovascular surgeon

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2022

The MANTA Vascular Closure Device: Requiring Attention From Beginning to End, Reply.

Cardiovascular revascularization medicine : including molecular interventions

View Source →
PubMed • 2022

Ultrasound-Guided Versus Conventional MANTA Vascular Closure Device Deployment After Transcatheter Aortic Valve Implantation.

The American journal of cardiology

View Source →
PubMed • 2022

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 →
PubMed • 2021

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 →
PubMed • 2021

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 →
PubMed • 2021

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 →
ClinicalTrials.gov

Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

View Source →
ClinicalTrials.gov

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.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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