Abbott is committed to providing haemostasis management solutions to help patients and hospitals thrive.
Our haemostasis management portfolio aims to drive hospital efficiency through:1-5
PercloseTM ProStyleTM
PercloseTM ProGlideTM
PercloseTM family of products deliver a non-masking percutaneous suture to the access site that promotes primary healing†6 and has no re-access restrictions.7, 8
Perclose™ family of products – ProStyle™ and ProGlide™, have the broadest indication for both femoral arterial and venous access.*
For arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
For venous sheath sizes greater than 8F, at least one device and the pre-close technique are required.
#Max. OD 26F/0.340 inches/8.62 mm; Max. OD 29F/0.378 inches/9.59 mm. Tests performed by and data on file at Abbott.9
† Primary intention healing occurs where vessel wall edges are brought together, adjacent to each other. This can be achieved with sutures and other methods.6
*As compared to Angio-Seal‡, ExoSeal‡, FemoSeal‡, InClosure‡, MANTA‡, Mynx‡, PerQseal‡, Vascade‡, Velox CD‡, X-Seal‡. Data on file at Abbott.
With a legacy of more than 12 million repairs over 27 years, Perclose ProGlideTM has been helping clinicians achieve rapid and durable haemostatis** with the certainty of percutaneous suture-mediated repair.4
**In the REALISM clinical trial Perclose™ cohort (n = 159), mean time to achieve haemostasis was 5.92 ± 6.19 minutes and freedom from major femoral vein access-related complications through 30 days was 98.1%.4
Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System is the next-generation design evolution of the proven and trusted Perclose ProGlide™ SMC System.
View the animations for System Overview, Device Preparation, and full deployment steps for Single Device Deployment and Multiple Device Deployment techniques.
Note the key difference in suture management from ProGlide™ SMC system is the additional step involving the snared knot pusher.8
View the animations for full deployment steps for single and multiple devices.
Objective:
To compare the safety and effectiveness of the 'pre-close' technique for percutaneous femoral artery (FA) access and closure (PEVAR) to Surgical Cutdown (SEVAR).
Major Ipsilateral Vascular Access
Complications at 30 Days†
Composite of Minor Ipsilateral Vascular Access
Complications at 30 Days‡
†Major Complications: access site vascular injury requiring repair; new onset lower extremity ischaemia requiring surgical or percutaneous intervention; Access site-related bleeding requiring transfusion; access site-related infection requiring IV antibiotic or prolonged hospitalisation; access site-related nerve injury that is permanent or requires surgery.
‡Minor Complications: pseudoaneurysm or AV fistula; hematoma ≥ 6 cm; post-discharge bleeding requiring > 30 minutes to re-achieve hemostasis; lower extremity arterial emboli or stenosis attributed to access site; deep vein thrombosis; access site-related vascular laceration; transient access site-related nerve injury; access site wound dehiscence; access site-related lymphocele; localized access site infection treated with IM or PO antibiotic.
*PEVAR-Perclose analysed independently from ProstarTM XL.
**One-sided p-value and 95% confidence interval for non-inferiority test by using asymptotic test statistics with non-inferiority margin of 10%.
Objective:
To evaluate the safety and effectiveness of Perclose™ ProGlide™ in closing large-sized venous access sites through a retrospective data collection.
**Major complication is defined as any event leading to death, life-threatening or major bleeding, surgical intervention, hospitalisation, visceral ischemia or neurological impairment.7
Low major complications at 30 days
Objective:
Compare clinical outcomes and complication rates among patients undergoing closure of large-bore arterial access using Perclose™ (Perclose) versus Surgical Cutdown (Cutdown) in a real-world setting.
Patient baseline:
◊p<0.05
Key findings:
The use of Perclose for repair of large-bore arterial access is associated with significantly lower blood transfusions, infections, mortality, and length of stay compared to Surgical Cutdown.
Perclose patient outcomes:
Less likely to have an infection
Shorter hospital stay
Less likely to die within 30 days post-procedure
Less likely to require a blood transfusion
Time management, patient and staff flow, hospital costs, and throughput can all impact overall hospital efficiency. Access site management, early ambulation and discharge with Perclose ProGlide™ Suture-Mediated Closure System can help reduce patient length of stay, optimize nursing time, improve patient flow, and drive overall hospital efficiency.
Dr. Sumit Verma from Baptist Heart and Vascular Institute discusses how the facility implemented same-day discharge for atrial fibrillation ablation cases and how the strategy has the potential to reduce complications, decrease resource utilization, and allow cost savings, while improving patient satisfaction.
The StarClose SE™ Vascular Closure System (VCS) can be utilised after arterial access procedures using 5-6F introducer sheaths and provides safe16, easy and extravascular percutaneous closure after diagnostic or interventional procedures. The system offers:
*Defined as attainment of final haemostasis using any method and freedom from major vascular complications
Percutaneous Vascular Surgical (PVS) System is designed for use in conjunction with 8.5-24F sheaths and uses two braided sutures to provide a secure closure for femoral arterial access sites.17 When compared to manual compression, Prostar XL™ PVS System reduces time to haemostasis and ambulation.*9
*The STAND II randomised trial evaluated the use of the 8Fr or 10Fr Prostar™ Plus device versus traditional compression in 515 patients undergoing diagnostic or interventional procedures. Median time to haemostasis (19 vs 243 minutes, p <.01) and time to ambulation (3.9 vs 14.8 hours, p <.01) were significantly shorter for Prostar™ group.1
The FemoStopTM Compression Assist Device uses hands-free compression of the femoral artery or vein to offer precise haemostasis management and improved patient comfort compared to manual compression:
Offers Precise Placement and Control
Improves Staff Efficiency and Safety19
Watch FEMOSTOPTM GOLD step-by-step deployment
References
1. Baim DS, et al. Am J Cardiol 2000. 85(7): 864-9.
2. Verma S EP Lab Digest 2020. 20(8): 33-37.
3. Verma S, et al., Feasibility and Safety of Same Day Discharge for Patients Undergoing Atrial Fibrillation (AF) Ablation in a Community Hospital Setting., in HRS. 2020.
4. Kar S, et al. JACC: Cardiovascular Interventions 2018. 11(4): S35-S35.
5. Schneider DB, Perclose ProGlide vs Surgical closure outcomes - Real world evidence in LINC. 2018: Finland.
6. Salcido R Adv Skin Wound Care 2017. 30(6): 246-247.
7. Abbott, Perclose™ ProGlide™ SMC System - Instructions for Use (IFU).
8. Abbott, Perclose™ ProStyle™ SCMR System - Instructions for Use (IFU).
9. Abbott, Testing data on file.
10. Bhatt DL, et al. Am J Cardiol 2002. 89(6): 777-9.
11. Mercandetti M and Cohem A. Wound Healing and Repair. Updated: 22/01/2021 Available at: https://emedicine.medscape.com/article/1298129-overview [Accessed:21/09/2021].
12. Schneider DB, et al. J Comp Eff Res 2019. 8(16): 1381-1392.
13. Nelson PR, et al. J Vasc Surg 2014. 59(5): 1181-93.
14. Hermiller J, et al. J Invasive Cardiol 2005. 17(10): 504-10.
15. Abbott, StarClose SE™ VCS - Instructions for Use (IFU).
16. Burke MN, et al. Catheter Cardiovasc Interv 2012. 80(1): 45-52.
17. Abbott, Prostar XL™ Percutaneous Vascular Surgical System - Instructions for Use (IFU).
18. Abbott, Femostop™ Gold Compression Assist Device - Instructions for Use (IFU).
19. Sridhar K, et al. Cathet Cardiovasc Diagn 1996. 39(3): 224-9.
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