The Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System is the next generation design evolution of the proven and trusted Perclose ProGlide™ SMC System.
Similar to Perclose ProGlide™ SMC System, each Perclose™ ProStyle™ device delivers the same secure, non-masking percutaneous suture to the access site that promotes primary healing6 and has no reaccess restrictions1.
The updated Perclose™ ProStyle™ SMCR System has been designed with features such as higher tensile-strength needles for more reliability in complex, challenging anatomy5, additional visual cues for a more intuitive deployment experience5, and the addition of our popular Perclose™ Snared Knot Pusher which has only been available in the U.S. until now1.
Along with Perclose ProGlide™ SMC System, this updated system shares the same broadest arterial and venous indication*, and can be utilized for 5-21F2 (Max. 26F OD4) arterial sheaths and 5-24F3 (Max. 29F OD4) venous sheaths. Abbott’s Perclose™ ProStyle™ SMCR System also offers the same benefits:
Reduced time to hemostasis, ambulation and discharge7,8
Ability to challenge and confirm closure complete hemostasis on the table1
Minimized inflammatory response9
Significantly lower blood transfusions, infections, mortality and shorter length of stay compared to surgical cutdown for large-bore arterial access10
Low major access site-related complications for large-bore venous access11
For EP labs, click hereto discover how Perclose™ ProStyle™ can improve EP lab workflow and enhance patient experience.
Broadest Indication*
The Perclose™ ProStyle™ SMCR System has the broadest indication for both femoral arterial and venous access.
For common femoral access sites
Max. OD
Artery
5–21F2
26F
Vein
5–24F3
29F
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.
Parallels the Surgical Gold Standard
Associated with significantly lower blood transfusions, infections, mortality, and shorter length of stay compared to surgical cutdown10
Secure repair with pre-tied polypropylene monofilament suture1
Minimal intravascular footprint
Promotes Vessel Healing
Minimizes inflammatory response9
No re-access restrictions after using Abbott vascular closure devices1
Gives In-Lab Confidence
Low access site-related complication,10,11 reduces time to hemostasis, ambulation, and discharge as compared to manual compression7,8
Suture repair can be challenged and confirmed on the table1
Ability to maintain wire access1
Suture-Based
Primary Intention Healing
Primary Wound Healing with Suture Repair
Clean Incision
Early Suture
"Hairline" Scar
Frequently Asked Questions
Are the indications the same between Perclose™ ProStyle™ and Perclose ProGlide™?
Yes, the indications are identical between Perclose™ ProStyle™ and Perclose ProGlide™ and each device can be used after the same types of percutaneous transfemoral procedures. These Perclose™ devices still maintain the broadest indication* amongst vessel closure devices in the market:
Common Femoral Arteries: 5-21F2 (Max. OD 26F4)
Common Femoral Veins: 5-24F3 (Max. OD 29F4)
Will Perclose ProGlide™ be discontinued?
The Perclose™ ProStyle™ SMCR System is the next-generation design evolution of the proven and trusted Perclose ProGlide™ SMC System, and it has been improved based on years of customer input and feedback. Although the conversion will take a few years, the updated Perclose™ ProStyle™ SMCR System is an overall better device and we should want our customers to make the switch for improved reliability, enhanced usability, and a more intuitive deployment experience.
What features of Perclose™ ProStyle™ have been updated to improve the reliability and performance over that of Perclose ProGlide™?
Stronger Needles in Perclose™ ProStyle™5
Designed to reduce the frequency of needle deflection in more complex challenging anatomy, resulting in cuff misses
Reduced Plunger Spring force5
The Plunger spring force was reduced to eliminate Plunger rebound and improve needle-to-cuff engagement at the end of Step 2 (Depressing the Plunger to Deploy the Needles)
Lubrication added to the Cuffs of the Foot5
Lubrication has been added to the anterior and posterior cuffs of the Foot to reduce the overall deployment force required to depress the Plunger and deploy the Needles.
What makes the needles in Perclose™ ProStyle™ stronger? What is the impact of stronger needles during deployment?
The material of the anterior and posterior needles of Perclose™ ProStyle™ was changed from the normal Stainless Steel (used in Perclose ProGlide™) to a custom High Tensile Stainless Steel with 11-16% increased needle strength to minimize needle deflection and improve needle penetration through less compliant anatomy.5
The higher tensile strength needles in Perclose™ ProStyle™ minimize needle deflection, reduce cuff misses and improve needle penetration through complex, challenging and less compliant anatomy.5
During benchtop testing, Perclose™ ProStyle™ demonstrated a 15% improved success rate of suture deployment over that of Perclose ProGlide™ for better reliability and performance in more complex, challenging and less compliant anatomy.5
What features have been added to the Perclose™ ProStyle™ SMCR System to increase ease of use and ease of learning?
Matching Depth Reference Markers5
New matching Depth Reference Markers have been added to the Perclose™ ProStyle™ device and Suture Trimmer to provide an optional visual estimation of the access site depth
The distance between the center of each Depth Reference Marker is exactly 1 cm apart and are easy to see, thus improving ease of learning and ease of use
Guide Wire Exit Port5
The Guide Wire Exit Port is the same as that of Perclose ProGlide™, however, the printing area surrounding the Guide Wire Exit Port has been increased by 329%
This modification of the printing design improves visibility of the Guide Wire Exit Port and can improve the ease and efficiency of regaining guide wire access
QuickCut™5
The opening area of QuickCut™ has been redesigned by increasing the suture capture area by approximately 39% to facilitate easier and more efficient suture capture and trimming of the suture at the end of Step 3 (Pull the Plunger back to deploy the Sutures)
Thumb Knob and Suture Gate5
The Thumb Knob and Suture Gate on the updated Perclose™ ProStyle™ Suture Trimmer have been updated with matching white colors to improve ease of use and ease of learning when opening the Suture Gate
When the white Thumb Knob is retracted, the white Suture Gate opens, providing a more intuitive experience when using the Suture Trimmer
Trimming Lever and Suture Trimmer Blade5
The spring rate on the red Trimming Lever has been increased to reduce the potential for accidental trimming
The Suture Trimmer Blade design was modified to remove a laser cut force reduction feature on the shaft, improving cutting efficiency and tactile feedback during trimming for improved ease of use
Perclose Snared Knot Pusher5
This accessory knot advancement provides an alternative option to the Suture Trimmer with a tapered shaft for easier insertion, a longer working length for deeper tissue tracts, and concave tip that sits on top of the knot for more tactile knot advancement
White-tipped Non-Rail5
The white marking on Non-Rail suture limb is created by using a shrink tubing on the end of the suture limb
The amount of white pigment in the shrink tubing has been increased by 250% to provide better contrast and differentiation from the blue Rail suture limb and ease the visual identification of the white-tipped Non-Rail suture limb.
Additional hydrophilic coatings5
Perclose™ ProStyle™ device
The tapered Sheaths of both Perclose ProGlide™ and Perclose™ ProStyle™ are coated with the same hydrophilic coating
With Perclose™ ProStyle™, the same hydrophilic coating has been extended up to coat Distal Guide as well, to further ease device advancement by reducing the insertion force required when advancing the device into the body5
During benchtop testing, the mean coefficient of kinetic friction at the Distal Guide was 27% lower for Perclose™ ProStyle™ compared to Perclose ProGlide™, allowing for improved ease of device advancement5
Perclose ProStyle Suture Trimmer
A hydrophilic coating has also been added to the Sheath of the Perclose™ ProStyle™ Suture Trimmer for improved ease of use during knot advancement through the tissue tract5
References
*As compared to Angio-Seal‡, ExoSeal‡, FemoSeal‡, InClosure‡, MANTA‡, Mynx‡, PerQseal‡, Vascade‡, Velox CD‡, X-Seal‡. Data on file at Abbott.
Perclose™ ProStyle™ SMCR System – Instructions for Use (IFU)
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.
Tests performed by and data on file at Abbott.
Primary intention healing occurs where vessel wall edges are brought together, adjacent to each other. This can be achieved with suture, stitches, staples and clips. Advances in Skin & Wound Care: Healing by Intention. Salcido, Richard. 2017.
Time to hemostasis, ambulation and discharge applies to the arterial access.
Bhatt, Deepak L. et al. Successful “Pre-Closure” of 7Fr and 8Fr Femoral Arteriotomies With a 6Fr Suture-Based Device (The Multicenter Interventional Closer Registry). American Journal of Cardiology Vol 89. March 2002.
Mercandetti, Michael. Wound Healing and Repair. Medscape. WebMD, 02 April 2019. Web. January 15, 2020.
Perclose ProGlide™ Versus Surgical Closure Outcomes – Real World Evidence. Schneider, Darren B; Krajcer, Zvonimir; et al. LINC 2018.
The Use of the Perclose ProGlide™ Suture Mediated Closure (SMC) Device for Venous Access-Site Closure up to 24F Sheaths. Kar, Saibal; Hermiller, James; et al. CRT 2018.
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The following content is intended for Healthcare Professionals except for those in France. Some of the content is not in compliance with the French Advertising law N°2011-2012 dated 29th December 2011, article 34.
Si vous êtes un professionnel de santé exerçant en France ou dans les territoires Français, veuillez visiter notre site en français.
