Yes, Perclose™ ProStyle™ can be used in conjunction with a variety of AFib ablation techniques, including Pulsed Field Ablation (PFA) for venous sheaths up to 24F ID (29 OD).^1†

At the time of this publication, only Perclose™ Devices can close after all PFA systems including Farapulse‡ (13F Inner Diameter (ID), 16.8F Outer Diameter (OD)). ^§,1,†

Using a VCD has several advantages given the following factors during EP procedures such as AF ablations:

• Physicians often have multiple access sites to manage, even some involving large caliber venous sheaths.⁸
• Patients often receive full-dose peri-procedural anticoagulation, and this can make complete hemostasis a challenging and lengthy process, requiring prolonged immobilization.^9,10
• The typical EP lab post-procedure process requires the patient to remain immobilized for prolonged periods of time, which is a source of patient discomfort.⁹

All of these issues are mitigated when using the Perclose™ ProStyle™ closure device.

Yes, Same-Day Discharge has been shown to be safe, and it is being used to reduce the total cost of care and to enhance the patient experience. The use of vessel closure devices makes it possible for hospitals to implement Same-Day Discharge.^4,17,20,21

With the Perclose™ ProStyle™ device you can achieve and confirm complete hemostasis on the table with a suture-mediated repair of the access site. Other advantages of the Perclose ProGlide™ SMC System include:

• The broadest indication^† for use in both common femoral veins and arteries
• No ACT-level requirements, so reversal of heparin is not required in order to achieve immediate and durable hemostasis^1,13

Find out more about primary healing with the Perclose ProStyle™ vessel closure device.

The Perclose ProStyle™ closure device is indicated for use with:

• Venous sheaths 5-24F¹ (Max. OD 29F²² / 0.378 inches / 9.59 mm)
• Arterial sheaths 5-21F¹ (Max OD 26F²² / 0.340 inches / 8.62 mm)

No, there is only one Perclose™ ProStyle™ SMCR System. Multiple Perclose™ ProStyle™ devices can be used, if necessary, for large-bore vascular closure.

Because this device achieves immediate and durable hemostasis, patients may sit up immediately in bed.¹ Clinical evidence for cardiac arrhythmia treatments with multiple access sites has shown that patients safely ambulated within 2 hours^2,4,5,* and were eligible for same-day discharge after successfully closing with Perclose™ devices.^2,3,4,5**

It achieves hemostasis by approximating the edges of the vessel wall with a surgical suture, allowing primary intention healing to begin. Primary intention healing minimizes scarring and allows for immediate reaccess if needed. View primary intention healing images with vessel closure device.¹⁸

Contact your local Abbott representative for a training opportunity.

The "Pre-Close" Technique involves the Perclose™ ProStyle™ suture being placed around the access site before the index procedure, and it is required before using sheath sizes > 8F.¹
See Deployment and Instructions for Use for additional information.

^§ At the time of this publication (Oct 2024), for the following PFA systems: Farapulse^‡# (13F Inner Diameter (ID), 16.8F Outer Diameter (OD)), PulseSelect^‡ (9.5F ID; 14F OD), and Varipulse^‡ (8.5F ID; 11.5 OD)
^†As compared to Angio-Seal^‡, ExoSeal^‡, Celt ACD^‡, MANTA^‡, Mynx^‡, Vascade^‡. Data on file at Abbott.
*As observed in the VACCAR trial (≥1.4 hours) and the PRO-PVI trial (≥1:26 time to ambulation) after successful close with Perclose device(s) in patients who have undergone cardiac arrhythmia treatments with multiple common femoral venous access sites.
**As observed in the PROFA trial (80% discharged within 3:34h) and the PRO-PVI trial (≥3:38 hours post-procedural time to discharge) after successful close with Perclose device(s) in patients who have undergone cardiac arrhythmia treatments with multiple common femoral venous access sites.

1. Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System Instructions for Use (IFU). Refer to IFU for additional information.
2. Mohammed et al (2022) Comparative outcomes of vascular access closure methods following atrial fibrillation. Vascular Closure for Cardiac Ablation Registry. (VACCAR) J Interv Card Electrophysiol 64, 301 -310
3. Castro-Urda et al (2023) Efficacy and safety of Proglide use and early discharge after atrial fibrillation (PROFA trial) Pacing and Clinical Electrophysiology, 46(7), 598-606.
4. Fabbricatore D et al. (2023) Ambulatory PV isolation workflow using suture-mediated vascular closure devices: a prospective observational cohort study. (PRO-PVI Study). Europace. 25(4):1361-1368
5. Kiani S et al. (2022) Percutaneous Vascular Closure Compared with Manual Compression in AF Ablation. JACC JACC. Clinical electrophysiology, 8(6), 803 -805. (ESM trial)
6. Sekhar A, et al. Femoral arterial closure using ProGlide™ is more efficacious and cost-effective when ambulating early following cardiac catheterization. Int J Cardiol Heart Vasc. 2016;13:6-13. doi: 10.1016/j.ijcha.2016.09.002.
7. 18 million+ repairs based on August 2023 Finance Report. Data on file at Abbott.
8. Gupta S. I Just Need Some Closure: Getting Past Using Manual Compression After Ablation. HRS 2018.
9. Lakshmanadoss U, et al. Figure-of-eight suture for venous hemostasis in fully anticoagulated patients after atrial fibrillation catheter ablation. Indian Pacing Electrophysiol J. 2017;17:134-139. doi: 10.1016/j.ipej.2017.02.003
10. Okada M, et al. Efficacy and safety of figure-of-eight suture for hemostasis after RFCA for AF. Circ J. 2018;82:956-964. doi: 10.1253/circj.CJ-17-1213.
11. Ghannam M, et al. Protamine to expedite vascular hemostasis after catheter ablation of atrial fibrillation: A randomized controlled trial. Heart Rhythm. 2018;15(11):1642-1647. doi: 10.1016/j.hrthm.2018.06.045.
12. Mohanty S, et al. Venous access-site closure with vascular closure device vs. manual compression in patients undergoing catheter ablation or left atrial appendage occlusion under uninterrupted anticoagulation. EP Europace. 2019;21:1048-1054. doi.org/10.1093/europace/euz004.
13. Calkins H, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14(10):e275-e444. http://dx.doi.org/10.1016/j.hrthm.2017.05.012.
14. Kar, S., et al, The Use of Perclose ProGlide Suture-Mediated Closure (SMC) Device for Venous Access-Site Closure Up to 24F Sheaths. CRT 2018.
15. Mahadaven VS, et al. Pre-closure of femoral venous access sites used for large-sized sheath insertion with the Perclose device in adults undergoing cardiac intervention. Heart. 2008;94:571-572. doi.org/10.1136/hrt.2006.095935.
16. Sairaku A, et al. Rapid hemostasis at the femoral venous access site using a novel hemostatic pad containing kaolin after atrial fibrillation ablation. J Interv Card Electrophysiol. 2011;31:157-164.
17. Verma S. Adopting a strategy of early ambulation and same-day discharge for atrial fibrillation ablation cases. EP Lab Digest. 2019;19(5).
18. Mercandetti M. Wound Healing and Repair. Medscape. Accessed February 26, 2020. https://emedicine.medscape.com/article/1298129-overview
19. Bhatt DL, et al. Successful “pre-closure" of 7Fr and 8Fr femoral arteriotomies with a 6Fr suture-based device (the Multicenter Interventional Closer Registry). Am J Cardiol. 2002;89:777-779.
20. Bartoletti S, Mann M, Gupta A, et al. Same‐day discharge in selected patients undergoing atrial fibrillation ablation. Pacing Clin Electrophysiol. 2019;42:1448-1455.
21. Deyell M, Macle L, Khairy P, et al. The efficacy of a same-day discharge protocol after atrial fibrillation ablation. Canadian J Cardiol. 2018;34:(10 suppl):S84. doi:https://doi.org/10.1016/j.cjca.2018.07.281.
22. Data on file at Abbott.
23. Verma, S., et al, Feasibility and Safety of Same Day Discharge for Patients Undergoing Atrial Fibrillation (AF) Ablation in a Community Hospital Setting. HRS 2020 Science Online, May 2020.
24. Sun, J. Y., et al. (2023). Feasibility and clinical benefits of the double-ProGlide technique for hemostasis after cryoballoon atrial fibrillation ablation with uninterrupted oral anticoagulants. Journal of geriatric cardiology : JGC, 20(4), 268–275.
25. Ahmed, A, Bawa, D, Kabra, R. et al. EFFICACY OF VENOUS CLOSURE METHODS AFTER ELECTROPHYSIOLOGICAL PROCEDURES. J Am Coll Cardiol. 2023 Mar, 81 (8_Supplement) 147.
26. Richard Tilz, R et al  (2024) Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation -The STYLE-AF Study