📊 Evidence-Based Reference

perclose vascular suture delivery device

Abbott Vascular

Summary: The Perclose Vascular Suture Delivery Device is used for vascular closure following catheterization procedures. It is primarily utilized in endovascular therapies requiring large-bore access. Key evidence highlights its efficacy in achieving successful vascular closure.

FDA Clearance Information

Pathway 510K
Decision Date October 3, 2000
Product Code GAW
Device Class Class 2
Evidence 20 studies

The Perclose device was cleared by the FDA through the 510(k) pathway on October 3, 2000. It is manufactured by Abbott Vascular and classified as a Class 2 medical device.

What It Is

The Perclose Vascular Suture Delivery Device is a suture-mediated closure system designed to achieve hemostasis of the femoral artery access site following catheterization procedures. It is intended for use in patients undergoing diagnostic or interventional endovascular procedures.

Clinical Applications

Commonly used in procedures such as transcatheter aortic valve implantation (TAVI) and endovascular aneurysm repair (EVAR), the device facilitates rapid hemostasis and reduces the need for prolonged manual compression. It is particularly beneficial in cases requiring large-bore vascular access.

Evidence Summary

The literature includes 14 studies, comprising randomized controlled trials, prospective, and retrospective studies, with publication dates ranging from 2022 to 2025. These studies evaluate the device's efficacy and safety in various clinical settings.

Reported Outcomes

Published studies report that the Perclose device is effective in achieving vascular closure in patients undergoing large-bore endovascular procedures. The device has shown high closure success rates, particularly in procedures like TAVI and EVAR, where large-bore sheaths are used.

Safety Profile

Reported complications include minor bleeding and hematoma formation at the access site. However, the overall safety profile is favorable, with low incidences of major adverse events related to the device.

Evidence Limitations

While the device demonstrates efficacy in achieving vascular closure, further research is needed to evaluate long-term outcomes and potential complications in diverse patient populations. Current studies are limited by sample size and follow-up duration.

Linked Studies (20)

PubMed • 2025

Managing Femoral Artery Pseudoaneurysm Using Snare-Guided Through-and-Through Access With Perclose ProGlide.

Cureus

View Source →
PubMed • 2025

Safety and effectiveness of single ProStyle™/ProGlide™ for aortic endovascular procedures: single-style study.

Frontiers in cardiovascular medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Impact of venous closure systems on time to ambulation and discharge following AF ablation: a systematic review and meta-analytic review.

The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Vascular Closure Device Following Pulsed Field Ablation for Atrial Fibrillation: A Randomized Controlled Trial.

Pacing and clinical electrophysiology : PACE

RCT View Source →
PubMed • 2024

Efficacy and safety of post-closure technique using Perclose ProGlide/ProStyle device for large-bore mechanical circulatory support access sites.

Cardiovascular revascularization medicine : including molecular interventions

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Efficacy and Safety of Percutaneous Access Via Large-Bore Sheaths (22-26F Diameter) in Endovascular Therapy.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2024

Single suture-mediated closure system after transfemoral transcatheter aortic valve implantation: A single-center real-world experience.

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

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

Balloon-Assisted Perclose Suture Delivery for Large-Bore Vascular Access Closure After Transcatheter Aortic Valve Replacement.

Structural heart : the journal of the Heart Team

View Source →
PubMed • 2022

Percutaneous Decannulation Instead of Surgical Removal for Weaning After Venoarterial Extracorporeal Membrane Oxygenation-A Crossed Perclose ProGlide Closure Device Technique Using a Hemostasis Valve Y Connector.

Critical care explorations

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

Mid-term follow-up of percutaneous access for standard and complex EVAR using the ProGlide device.

The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland

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

Percutaneous Transgastric Duodenal Stenting and Gastrostomy Repair Using a Vascular Closure Device: Proof of Concept in a Porcine Model.

Surgical innovation

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2011

[Total percutaneous endovascular abdominal aortic aneurysm repair].

Zhonghua wai ke za zhi [Chinese journal of surgery]

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2009

Total percutaneous aortic repair: midterm outcomes.

Cardiovascular and interventional radiology

Prospective View Source →
PubMed • 2007

Total percutaneous endovascular repair of abdominal aortic aneurysms using Perclose ProGlide closure devices.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2001

Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices.

The Journal of invasive cardiology

RCT|prospective|retrospective|case Series|other View Source →
ClinicalTrials.gov

Perclose Multi-Access Duplex Ultrasound (DUS) Study

View Source →
ClinicalTrials.gov

Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR

View Source →
ClinicalTrials.gov

Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure

View Source →
ClinicalTrials.gov

Comparison of a Single Versus Double Perclose Technique for TAVR

View Source →
ClinicalTrials.gov

Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease

View Source →

Frequently Asked Questions

What are the clinical indications for the Perclose device?

The Perclose device is indicated for achieving hemostasis of the femoral artery following catheterization procedures, particularly in endovascular therapies requiring large-bore access.

What outcomes have been reported in clinical studies?

Clinical studies have reported high success rates in vascular closure, particularly in procedures like TAVI and EVAR, with effective hemostasis and reduced manual compression time.

What complications have been reported?

Reported complications include minor bleeding and hematoma formation at the access site, with a generally favorable safety profile and low incidence of major adverse events.

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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