Perclose ProStyle Suture-Mediated Closure System Overview | Abbott
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Don't Just Close it. Perclose™ it.

Perclose ProGlide

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 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 here to 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 5–21F3 26F
Vein 5–24F4 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 cutdown9
  • Secure repair with pre-tied polypropylene monofilament suture
  • Minimal intravascular footprint
Promotes Vessel Healing
  • Minimizes inflammatory response8
  • No re-access restrictions after using Abbott vascular closure devices2
Gives In-Lab Confidence
  • Low access site-related complication,9,10 reduces time to hemostasis, ambulation, and discharge as compared to manual compression7,11
  • Suture repair can be challenged and confirmed on the table2
  • Ability to maintain wire access2
Suture-Based
Primary Intention Healing

Primary Wound Healing with Suture Repair

Clean Incision

Clean Incision

Early Suture

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 is planned to replace Perclose ProGlide™ over time. The updated Perclose™ ProStyle™ SMCR System is an overall better device and we encourage our customers to take advantage of using it for their procedures.

  • 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, MANTA, Celt ACD, ExoSeal, Mynx, Vascade. Data on file at Abbott.

  1. 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.
  2. Abbott Perclose ProGlide Suture-Mediated Closure (SMC) System Instructions for Use.
  3. For arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
  4. For venous sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
  5. 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.
  6. Time to hemostasis, ambulation and discharge applies to the arterial access.
  7. 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.
  8. Mercandetti, Michael. Wound Healing and Repair. Medscape. WebMD, 02 April 2019. Web. January 15, 2020.
  9. Perclose ProGlide™ Versus Surgical Closure Outcomes – Real World Evidence. Schneider, Darren B; Krajcer, Zvonimir; et al. LINC 2018.
  10. 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.
  11. Applies to arterial access.

MAT-2102358 v1.0

Important Safety Information

IMPORTANT SAFETY INFORMATION
 

rx-only-logo  Perclose™ ProStyle™ Suture-Mediated Closure and Repair System

 

Indications: The Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access sites of patients who have undergone diagnostic or interventional catheterization procedures.

The Perclose™ ProStyle™ SMCR System is used without or, if required, with adjunctive manual compression.

For access sites in the common femoral artery using 5F to 21F sheaths.

For access sites in the common femoral vein using 5F to 24F sheaths.

For arterial and venous sheath sizes greater than 8F, at least two devices and the pre-close technique are required.

CAUTION:Federal law restricts this medical device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and / or interventional catheterization procedures and who has been trained by an authorized representative of Abbott.

Prior to use, the operator must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.

During closure of access sites using a procedural sheath greater than 8F, it is recommended that a vascular surgeon or a surgeon with vascular training be available in case surgical conversion to control bleeding and to repair the vessel is needed.

Contraindications: There are no known contraindications to the use of this device.

Warnings: Do not use the Perclose™ ProStyle™ SMCR System if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The Perclose™ ProStyle™ SMCR System is intended for single use only.

Do not use the Perclose™ ProStyle™ SMCR System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.

Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site. Note: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral vessel.

Do not use the Perclose™ ProStyle™ SMCR System in arterial access if the puncture is through the posterior wall or if there are multiple punctures in the same access site, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose™ ProStyle™ SMCR System in venous access if there are multiple punctures in the same access site, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site. Note: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the vessel.


Precautions:

  1. Prior to use, inspect the Perclose™ ProStyle™ SMCR System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function. Exercise care during device handling to reduce the possibility of accidental device breakage.
  2. As with all catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the Perclose™ ProStyle™ SMCR System. Employ appropriate groin management, as per hospital protocol, post procedure, and post hospital discharge to prevent infection.
  3. Use a single wall puncture technique. Do not puncture the posterior wall of the vessel in arterial access.
  4. Do not deploy the Perclose™ ProStyle™ Device at an angle greater than approximately 45 degrees, as this may cause a cuff miss.
  5. There are no reaccess restrictions if previous arteriotomy / venotomy repairs were achieved with Abbott Medical SMC or SMCR systems.
  6. If significant blood flow is present around the Perclose™ ProStyle™ SMCR Device, do not deploy needles. Remove the device over a 0.038" (0.97 mm) (or smaller) guide wire and insert an appropriately sized introducer sheath.
  7. Prior to pushing the plunger to advance the needles, stabilize the device by the body to ensure the foot is apposed to the vessel wall and the device does not twist during deployment. Twisting (torquing) of the device could lead to needle deflection resulting in a cuff miss. Do not use excessive force or repeatedly push the plunger. Excessive force on the plunger during deployment could potentially cause breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
  8. Do not apply excessive force to the lever when returning the foot to its original position down to the body of the device. Do not attempt to remove the device without closing the lever. Excessive force on the lever or attempting to remove the device without closing the lever could cause breakage of the device and / or lead to vessel trauma, which may necessitate intervention and / or surgical removal of the device and vessel repair.
  9. Do not advance or withdraw the Perclose™ ProStyle™ SMCR Device against resistance until the cause of that resistance has been determined. Excessive force used to advance or torque the Perclose™ ProStyle™ SMCR Device should be avoided, as this may lead to significant vessel damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
  10. If excessive resistance in advancing the Perclose™ ProStyle™ SMCR Device is encountered, withdraw the device over a 0.038" (0.97 mm) (or smaller) guide wire and reinsert the introducer sheath or use manual compression.
  11. Remove the Perclose™ ProStyle™ sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.
  12. Care should be taken to avoid damage to the suture from handling. Avoid crushing damage due to application of surgical instruments such as clamps, forceps or needle holders.
  13. For catheterization procedures using a 5 – 8F procedural sheath, use manual compression in the event that bleeding from the femoral access site persists after the use of the Perclose™ ProStyle™ SMCR System to obtain hemostasis.
  14. For catheterization procedures using a procedural sheath > 8F, use manual compression, compression assisted devices, surgical repair, and / or other appropriate treatment methods in the event that bleeding from the femoral access site persists after the use of the Perclose™ ProStyle™ SMCR System to obtain hemostasis.
  15. For catheterization procedures using a procedural sheath > 8F, where the operating physician is not a vascular surgeon, it is recommended that a vascular surgeon or a surgeon with vascular training be available during the procedure to perform any necessary vascular surgical intervention.



Potential Adverse Events: Potential adverse events associated with use of suture mediated closure devices may include, but are not limited to, the following:

  • Allergic reaction or hypersensitivity to device components
  • Vascular access complications which may require transfusion or vessel repair, including:
    • Anemia
    • Aneurysm
    • Arteriovenous fistula
    • Bleeding / hemorrhage / re-bleeding
    • Bruising / hematoma
    • Embolism
    • Inflammation
    • Intimal tear / dissection
    • Perforation
    • Pseudoaneurysm
    • Retroperitoneal hematoma / bleeding
    • Scar formation / calcification
    • Wound dehiscence
  • Cardiac arrhythmias (including conduction disorders, atrial and ventricular arrhythmias)
    • Atrial arrhythmias
    • Ventricular arrhythmias
  • Femoral artery / venous complications which may require additional intervention, including:
    • Arterial / venous stenosis
    • Arterial / venous occlusion
    • Arteriovenous fistula
    • Intimal tear / dissection
    • Ischemia distal to closure site
    • Nerve injury
    • Numbness
    • Thrombus formation
    • Vascular injury
  • Peripheral ischemic conditions (including deep vein thrombosis,
  • pulmonary embolism, post-procedure pulmonary embolism):
    • Deep vein thrombosis
    • Pulmonary embolism
  • Infection:
    • Infection / sepsis
  • Pain
  • Hemodynamic instability:
    • Hypotension / hypertension
    • Vasovagal episode
  • Death
  • Device complications
  • Device failure
  • Device malfunction

MAT-2100368 v2.0

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