đź“Š Evidence-Based Reference
Perclose Vascular Suture Delivery Device
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 ?
510(k)
Number ?
K001703 ↗
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.
FDA-Cleared Indications
- Femoral artery puncture-site closure following catheterization procedures.
- Achieving hemostasis at the femoral arterial access site after diagnostic or interventional endovascular procedures.
Clinical Applications
- Closure of femoral artery access sites after endovascular catheterization.
- Vascular closure after large-bore arterial access procedures.
- Access-site closure following transcatheter aortic valve implantation.
- Access-site closure following endovascular aneurysm repair.
- Closure after diagnostic or interventional femoral artery catheterization.
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.
Practical Considerations
- The device is intended for femoral arterial access-site closure; suitability depends on vessel size, puncture location, vessel anatomy and the specific device configuration.
- Accurate access-site placement and imaging or fluoroscopic guidance may be used to confirm the puncture location and guide deployment.
- Operators should assess for severe peripheral arterial disease, calcification, stenosis, infection, bleeding disorders and other factors that may increase closure failure or vascular-complication risk.
- Device compatibility, suture configuration and allowable sheath or access size vary by Perclose model and labeling; the current manufacturer instructions should be checked before use.
- MRI safety status is model-specific. Confirm the exact device and its labeling before an MRI examination; retained suture material alone is generally not the same as an implanted metal closure device.
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
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
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.