đź“Š Evidence-Based Reference
Perclose Prostyle Suture-Mediated Closure and Repair System
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, Hemostasis, Vascular
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.
FDA-Cleared Indications
- The FDA record describes a modification to the grit-blasting process on the push mandrel component of the Perclose ProStyle device.
- The device is indicated for suture-mediated closure and repair of common femoral artery access sites after percutaneous endovascular procedures, according to its product labeling.
Clinical Applications
- Closure of common femoral artery access sites after percutaneous endovascular procedures
- Femoral access-site closure following catheter-based aortic interventions
- Femoral access-site closure following procedures that use large-bore arterial sheaths, when performed according to the device labeling
- Suture-mediated repair of selected common femoral artery access sites
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.
Practical Considerations
- Use is limited by the device labeling, including the eligible access vessel, arterial anatomy, sheath size, and procedural technique.
- The operator must confirm suitable common femoral artery anatomy and avoid deployment through significant calcification, severe stenosis, unsuitable puncture location, or other contraindications listed in the instructions for use.
- The system is delivered through the femoral arterial access tract and requires appropriate imaging, vessel assessment, and sterile handling.
- MRI safety and conditional-use information should be confirmed in the current Abbott instructions for use and the specific implanted suture or device documentation; do not assume MRI compatibility from the device name alone.
- Potential complications include bleeding, hematoma, infection, arterial injury, thrombosis, stenosis, pseudoaneurysm, arteriovenous fistula, and failure of hemostasis. Additional compression or surgical or endovascular repair may be required.
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 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.