📊 Evidence-Based Reference

perclose prostyle suture-mediated closure and repair system

Abbott Vascular

Summary: The Perclose ProStyle is a suture-mediated closure system used primarily for vascular closure post-endovascular procedures. Key evidence highlights its efficacy in reducing hemostasis time and its safety in large-bore access sites.

FDA Clearance Information

Pathway PMA

Number P960043 ↗

Decision Date October 27, 2021

Product Code MGB

Device Class Class 3

Evidence 20 studies

The Perclose ProStyle was cleared by the FDA through the PMA pathway on October 27, 2021. It is manufactured by Abbott Vascular and classified as a Class III device.

What It Is

The Perclose ProStyle is a suture-mediated closure and repair system designed to achieve hemostasis in the common femoral artery following percutaneous endovascular procedures. It utilizes a suture-based mechanism to close arterial access sites.

Clinical Applications

Commonly used in endovascular procedures requiring femoral artery access, the device is particularly useful in scenarios involving large-bore access such as mechanical circulatory support and aortic interventions.

Evidence Summary

The literature includes a mix of randomized controlled trials, prospective and retrospective studies, and case series, with a total of 9 studies published between 2024 and 2025.

Reported Outcomes

Published studies report that the Perclose ProStyle is effective in reducing hemostasis and bedrest times post-procedure. It has been shown to safely close large-bore access sites, such as those required for mechanical circulatory support devices.

Safety Profile

Reported complications include iatrogenic femoral artery pseudoaneurysm, which can be managed using the device. Overall, the device demonstrates a favorable safety profile in the studies reviewed.

Evidence Limitations

Current evidence is limited by the lack of long-term follow-up data and direct comparisons with alternative closure methods. Further research is needed to evaluate cost-effectiveness and patient-reported outcomes.

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 Perclose ProStyle?

The device is indicated for vascular closure following percutaneous endovascular procedures, particularly in the common femoral artery.

What outcomes have been reported in clinical studies?

Studies report reduced hemostasis and bedrest times, with successful closure of large-bore access sites.

What complications have been reported?

Safety data indicate potential complications such as femoral artery pseudoaneurysm, manageable with the device.

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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📄 Articles

perclose prostyle suture-mediated closure and repair system

FDA Clearance Information

What It Is

Clinical Applications

Evidence Summary

Reported Outcomes

Safety Profile

Evidence Limitations

Linked Studies (20)

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

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

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

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

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

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

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

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

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.

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

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

[Total percutaneous endovascular abdominal aortic aneurysm repair].

Total percutaneous aortic repair: midterm outcomes.

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

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.

Perclose Multi-Access Duplex Ultrasound (DUS) Study

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

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

Comparison of a Single Versus Double Perclose Technique for TAVR

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

Frequently Asked Questions

What are the clinical indications for Perclose ProStyle?

What outcomes have been reported in clinical studies?

What complications have been reported?

FDA Clearance Information

What It Is

Clinical Applications

Evidence Summary

Reported Outcomes

Safety Profile

Evidence Limitations

Linked Studies (20)

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

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

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

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

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

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

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

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

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.

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

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

[Total percutaneous endovascular abdominal aortic aneurysm repair].

Total percutaneous aortic repair: midterm outcomes.

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

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.

Perclose Multi-Access Duplex Ultrasound (DUS) Study

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

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

Comparison of a Single Versus Double Perclose Technique for TAVR

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

Frequently Asked Questions

What are the clinical indications for Perclose ProStyle?

What outcomes have been reported in clinical studies?

What complications have been reported?

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