CARDIOVASCULAR
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SUTURE-MEDIATED CLOSURE FOR BOTH ARTERIAL AND VENOUS ACCESS

Perclose ProGlide™ SMC System delivers a secure, non-masking percutaneous suture to the access site that promotes primary healing3 and has no re-access restrictions.

This system has the broadest arterial and venous indication*; it can be utilized for 5-21F2 (Max. 26F OD1) arterial sheaths and 5-24F2 (Max. 29F OD1) venous sheaths. Abbott’s Perclose ProGlide™ SMC System also offers the following benefits:

  • Reduced time to hemostasis, ambulation and discharge compared to manual compression4,5
  • Ability to challenge and confirm closure on the table5
  • Minimized inflammatory response5
  • Significantly lower blood transfusions, infections, mortality, and shorter length of stay compared to surgical cutdown for large bore-arterial access6
  • Low major access site-related complications for large-bore venous access7

To learn more, click here to request a hands-on demo

And for EP labs, click here to discover how Perclose ProGlide™ SMC System can improve EP lab workflow and enhance patient experience.

BROADEST INDICATION*

The Perclose ProGlide™ vascular closure system has the broadest indication for both femoral arterial and venous access

 

For common femoral access sites

 

 

Suture-Based

 

The use of Perclose ProGlide™ for repair of large bore arterial access is associated with significantly lower blood transfusions, infections, mortality, and length of stay compared to cutdown.6

The use of Perclose ProGlide™ for large-bore venous access is also associated with low major access site-related complications.7

 

 

Primary Intention

 

PARALLELS THE SURGICAL GOLD STANDARD
  • Associated with significantly lower blood transfusions, infections, mortality, and shorter length of stay compared to surgical cutdown6
  • Secure repair with pre-tied polypropylene monofilament suture
  • Minimal intravascular footprint
PROMOTES VESSEL HEALING
  • Minimizes inflammatory response5
  • No re-access restrictions after using Abbott vascular closure devices
GIVES IN-LAB CONFIDENCE
  • Low access site-related complication,6,7 reduces time to hemostasis, ambulation, and discharge as compared to manual compression4,5
  • Suture repair can be challenged and confirmed on the table5
  • Ability to maintain wire access

Clean Incision

Early Suture

"Hairline" Scar

SINGLE DEVICE DEPLOYMENT

Refer to Instructions for Use for additional information.

Need more info about single device deployment training? Learn More

Request a hands-on demo from your local Abbott representative. Hand-On Demo

  • PRE-DEPLOYMENT
    • Flush Marker Lumen

     

    • Insert device over the guide wire
    • Remove guide wire when Guide Wire Exit Port is at skin level
    • Advance device until pulsatile flow is observed from Marker Lumen
  • SUTURE DEPLOYMENT

    1

    Advance device and lift Lever (Open Foot). In the vein, blood may only fill the Marker Lumen. Lift Lever to open the Foot

    2

    Depress Plunger (Deploy Needles). Retract device until the Foot has apposition against the vessel wall. Stabilize the device to approximately 45°, maintaining gentle retraction against the vessel wall and depress Plunger. Cessation of blood from the Marker Lumen may be noted

    3

    Pull Back Plunger (Deploy Suture). Pull suture taught and cut suture using the QuickCut®

    4

    Lower Lever (Close Foot). Relax device and return Lever to the original position
  • SUTURE MANAGEMENT
    • Retract device until Guide Wire Exit Port is at skin level
    • Remove the suture limbs
      • Blue limb = Rail
      • White limb = Non-Rail
    • Insert guide wire into Guide Wire Exit Port
    • Remove device while pulling tension on Rail (blue)
    • Load Snare Knot Pusher (SKP) on to Rail (blue) suture
    • Apply slow consistent tension to advance knot down to vessel
    • Assess hemostasis and remove guide wire while maintaining tension on Rail suture
    • Lock knot by pulling on Non-Rail (white) suture
    • Use right thumb to pull back the Thumb Knob on the Suture Trimmer to load both suture limbs
    • Advance Suture Trimmer down to vessel
    • Use right index finger to pull back the Red Lever; cut suture
  • ASSESS HEMOSTASIS
    Challenge and Confirm the Close

     

    • Have the patient bend leg/lift head and cough
    • If further knot tightening is required, repeat Suture Management steps

MULTIPLE DEVICE DEPLOYMENT

Refer to Instructions for Use for additional information.

Need more info about single device deployment training? Learn More

Request a hands-on demo from your local Abbott representative. Hand-On Demo

  • PRE-CLOSE TECHNIQUE
    • Pre-close technique means the Perclose ProGlide™ suture is placed around the arteriotomy at the beginning of the procedure and knot advancement is placed on hold until the procedure is complete
    • The pre-close technique for sheath sizes greater than 8F, at least two devices and the pre-close technique are required

     

  • PRE-DEPLOYMENT
    • Flush Marker Lumen
    • Insert the first of two devices over the guide wire
    • Remove guide wire when Guide Wire Exit Port is at skin level
    • Advance device until pulsatile flow is observed from Marker Lumen. In the vein, blood may only fill the Marker Lumen
    • Rotate the device 30° toward the patient's right side
  • SUTURE DEPLOYMENT

    1

    Lift Lever to open Foot. Do NOT open Foot before rotating device 30°

    Retract device against anterior wall of vessel until marking has stopped

    2

    Stabilize device at 45º while maintaining gentle retraction against the vessel wall. Depress the plunger to deploy the needles.

    3

    Remove Plunger using the thumb as a fulcrum. Pull suture taught. Cut suture with QuickCut or scissors

    4

    Relax device and return Lever down to its original position
  • SUTURE MANAGEMENT
    • Retract device until Guide Wire Exit Port is at skin level
    • Remove the sutures and hold sutures tightly together
      • Blue limb = Rail
      • White limb = Non-Rail
    • Place a hemostat or clamp to hold the two sutures together at the distal end of the Non-Rail (white)
    • Pull on clamp until the suture is taut. Place clamped suture on patient's right side under sterile towel
    • Re-insert guide wire and remove device
  • SECOND DEVICE DEPLOYMENT
    • Repeat Pre-Deployment steps for each device
    • Second Device
      • Insert the device and rotate 30° toward the patient's left side and repeat deployment steps
      • Repeat suture management steps and place clamped suture on patient's left side under sterile towel
      • Knot advancement will be on hold until the end of procedure
    • Third device (optional as needed)
      • Third device should not be rotated. Device will deploy in a straight position
     

     

  • END OF PROCEDURE SUTURE MANAGEMENT
    • At the end of the procedure, advance a guide wire into the vessel
    • Remove clamp from first suture placed at patient's right side

    Hold manual compression during sheath system removal and initial suture advancement

    • Wrap Rail (blue) around left forefinger and hold coaxial to tissue tract
    • Remove sheath and pull Rail (blue) simultaneously and slowly to advance suture knot
    • Re-clamp and return the suture to the right side of the patient to identify the first sutures deployed
    • Repeat steps above for suture set 2 and place on left side of patient. Repeat for suture set 3 if a third device was deployed
    • Do not lock or excessively tighten the knot while the guide wire is in the vessel
    • Use Snared Knot Pusher (SKP) to complete knot advancement and to lock the knot
    • The suture knots must be advanced in the order they were placed
    • Load Snared Knot Pusher (SKP) on to Rail (blue) suture of the first suture set placed on patient's right side
    • Advance Shared Knot Pusher (SKP) coaxial down to the vessel
    • Pull on the Non-Rail (white) suture to lock the knot
    • Repeat steps for sutures placed on patient's left side
    • Remove guide wire once bleeding is controlled
    • Load Snared Knot Pusher (SKP) on to Rail (blue) suture patient's right side and lock knot by pulling on the Non-Rail (white) suture
    • Repeat for sutures placed on the patient's left side
  • ASSESS HEMOSTASIS
    • Assess hemostasis after all knots are advanced and locked
    • If adequate hemostasis is not observed, advance each knot again starting with the first suture deployed followed by the second suture deployed
    • Trim all sutures once adequate hemostasis is observed

The studies shown below are examples of the safety and benefits that Perclose ProGlide™ SMCS may provide patients requiring small or large sheaths in artieral or venous access procedures.

PERCLOSE PROGLIDE™ SMCS VS. MANUAL COMPRESSION

A study showing ambulation times, costs and patient satisfaction between the two methods of hemostasis approaches.

 

CLINICAL OUTCOMES  |  COST ANALYSIS  |  PATIENT SATISFACTION  |  SUMMARY

 

 

Study Overview

Femoral arterial closure using ProGlide™ is more efficacious and cost-effective when ambulating early following cardiac catheterization.
International Journal of Cardiology: Heart and Vasculature, 2016

 

Background

It is unclear whether early ambulation with Perclose ProGlide™ Suture-Mediated Closure System is safe or is associated with patient satisfaction and cost savings as compared with manual compression.

 

Objective

Evaluate the efficacy and cost-effectiveness of early ambulation (within 30 minutes) following femoral artery closure with the Perclose ProGlide™ SMCS in patients undergoing diagnostic cardiac catheterization compared with manual compression.

 

Method

Prospective, single-center study of 170 patients equally split into two arms measuring patient ambulation (20 feet within 30 minutes), time to hemostasis, and time to discharge. Using a fully allocated cost model, a cost analysis of both Perclose ProGlide™ SMCS and manual compression was performed. Also, a multivariate analysis was used to determine predictors of patient satisfaction.

 

Primary Endpoint

The primary endpoint was time-to-ambulation (TTA) following device closure.

 

Clinical Outcomes
  Perclose ProGlide™ SMCS
(n = 85)
Manual Compression
(n = 85)
P-value
Time to hemostasis (mean) 1.5 min 20.4 min <0.001
Time to ambulation (mean) 27.1 min 248.0 min <0.001
Time to discharge (mean) 59.6 min 349.9 min <0.001
Procedural success 100% (85/85) 96% (82/85) 0.12
Overall complications 3.5% (3/85) 11.8% (10/85) 0.08

 

Cost Analysis

Perclose ProGlide™ SMCS provided nearly $1,000 in cost savings per patient compared to manual compression.

 

  Perclose ProGlide™ SMCS
(n = 85)
Manual Compression
(n = 85)
Total procedural cost
(without hemostasis device)
$564.5 ± 132.3 $553.7 ± 121.0
Hemostasis device cost1 $278.2 ± 77.4 $41.6 ± 22.4
Post-procedural cath lab holding2 $308.5 ± 78.8 $1,190.8 ± 333.6
Total adjusted nursing costs3 $99.1 ± 41.1 $389.5
Hospital adjusted in-patient expenses4 $0.0 $2,052.6 ± 250.2
Total cost $1,250.3 ± 146.4 $2,248.1 ± 910.2
Incremental savings per patient $983.6  

 

Patient Satisfaction

Perclose ProGlide™ SMCS helps reduce severe levels of patient discomfort as compared to manual compression.

Summary
  • Perclose ProGlide™ SMCS provided significantly shorter times to hemostasis, ambulation, and discharge.
  • Perclose ProGlide™ SMCS provided nearly $1,000 in cost savings per patient compared to manual compression.
  • Perclose ProGlide™ SMCS helped reduce severe levels of patient discomfort as compared to manual compression.
  •  

PERCLOSE PROGLIDE™ SMCS U.S. LARGE-HOLE STUDY FOR EVAR

An overview of the Least Invasive Fast-Track EVAR (LIFE) Registry

 

CLINICAL OUTCOMES | COST ANALYSIS | SUMMARY

 

Study Overview

Fast-Track Endovascular Aortic Repair: Final Results from the Prospective LIFE registry.
VIVA 2016

 

Objective

Demonstrate the clinical and cost benefits associated with the ultra-low profile (14F) Ovation‡ Abdominal Stent Graft platform under the least invasive conditions, including percutaneous access, no general anesthesia, no ICU admission, and next-day discharge.

 

Method

Prospective, non-randomized, multi-center post-market study of 250 patients at 35 U.S. centers

 

Primary Endpoint

Major adverse event within 30 days (10.4% target performance goal)

 

Secondary Endpoint
  • Treatment success (completion of Fast-Track protocol)
  • Procedure, fluoroscopy, and anesthesia time; access complications; ambulatory status, hospital stay; quality of life
  • Freedom from type I/III endoleak; conversion to open repair, rupture, AAA-related reintervention; mortality

 

Clinical Outcomes

Perclose ProGlide™ SMCS had a high technical success rate with no device or procedure-related major adverse events.

 

  Perclose ProGlide™ SMCS
(n = 250)
Technical success 97.6%
Device-related MAE 0%
Procedure-related MAE 0%
Hours to ambulation (median) 7.9 Hours
Hospital stay (mean) 1.2 days

 

Cost Analysis

The Fast-Track EVAR approach demonstrates $21,100 in savings as compared to the Standard EVAR approach, with the hospital stay contributing to the majority of the amount.

  Standard EVAR1-2 Fast-Track EVAR Fast-Track Savings
Anesthesia General, 84%
$500
Local, 100%
$300
$200
Access Cutdown3
$300
Bilateral PEVAR
$1,200
($900)
ICU 1.4 Days, 51%
$15,300
0 Days, 0%
$0
$15,300
Non-ICU 2.3 Days
$12,900
1.2 Days
$6,700
$6,200
30-Day Reintervention $29,400, 1.1%
$300
0%
$0
$300
Total $29,300 $8,200 $21,100

 

Summary

Perclose ProGlide™ SMCS had a high technical success rate with no device- or procedure-related major adverse events.

The Fast-Track EVAR approach demonstrates $21,100 in savings as compared to the Standard EVAR approach, with the longer hospital stay contributing to the majority of the difference.

ABBOTT EDUCATION NETWORK

ACCESS RESOURCES FOR TECHNIQUES AND BEST PRACTICES FOR SUCCESSFUL VASCULAR CLOSURE

If you’re an attending physician, fellow, resident or other clinician and interested in mastering vascular suture-mediated or clip closure, sign up for Abbott Education Network’s Vascular Closure Resource Center. The content includes information on Abbott’s Perclose ProGlide™ Suture-Mediated Closure System and StarClose SE™ Vascular Closure System. The Resource Center covers techniques and best practices to achieve the best possible outcomes for your patients.

 

Download on the App Store

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ORDERING INFORMATION


DESCRIPTION STOCK NUMBER UNITS PER PACKAGE INCLUDES
Perclose ProGlide™
Suture-Mediated Closure System
12673-03 10 (1) Perclose ProGlide™
Suture-Mediated Closure Device
(1) Suture Trimmer
(1) Snared Knot Pusher

  • References

    *As compared to Angio-Seal, MANTA, Celt ACD, ExoSeal, Mynx, Vascade. Data on file at Abbott.
    1. 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.
    2. For sheath sizes greater than 8F, at least two devices and pre-close technique are required. U.S. Perclose ProGlide™ SMC System Instructions for Use.
    3. Primary intention healing occurs where vessel wall edges are brought together, adjacent to each other. This can be achieved with sutures and other methods. Advances in Skin & Wound Care: Healing by Intention. Salcido, Richard. 2017
    4. Time to hemostasis, ambulation and discharge applies to the arterial access. U.S. Perclose ProGlide™ SMC System Instructions for Use.
    5. U.S. Perclose ProGlide™ SMC System Instructions for Use.
    6. Perclose ProGlide™ Versus Surgical Closure Outcomes – Real World Evidence. Schneider, Darren B; Krajcer, Zvonimir; et al. LINC 2018.
    7. 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.

CLICK HERE TO BEGIN TRAINING

IMPORTANT SAFETY INFORMATION

Rx Perclose ProGlide™ Suture-Mediated Closure (SMC) System

INDICATIONS

The Perclose ProGlide™ SMC System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures.
The Perclose ProGlide™ SMC 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 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 Vascular.

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 close the vessel is needed.

CONTRAINDICATIONS

There are no known contraindications to the use of this device. Attention is drawn to the WARNINGS and PRECAUTIONS sections.

WARNINGS

Do not use the Perclose ProGlide™ SMC device or accessories 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 ProGlide™ SMC device and accessories are intended for single use only.

Do not use the Perclose ProGlide™ SMC 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 ProGlide™ SMC 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 artery or vein.

Do not use the Perclose ProGlide™ SMC System if the puncture is through the posterior wall or if there are multiple punctures, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose ProGlide™ SMC 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 femoral artery or vein.

PRECAUTIONS

1. Prior to use, inspect the Perclose ProGlide™ SMC 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 ProGlide™ SMC 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.

4. Do not deploy the Perclose ProGlide™ SMC device at an angle greater than 45 degrees, as this may cause a cuff miss.

5. There are no reaccess restrictions if previous access site repairs were achieved with Abbott Vascular SMC devices.

6. If significant blood flow is present around the Perclose ProGlide™ SMC device, do not deploy needles. Remove the Perclose ProGlide™ SMC device over a 0.038" (0.97mm) (or smaller) guidewire and insert an appropriately sized introducer sheath.

7. When pushing the plunger assembly to advance the needles, stabilize the device to ensure the device does not twist or move forward during deployment. Twisting the device could lead to needle deflection resulting in a cuff miss. Do not use excessive force or repeatedly push the plunger assembly. 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 (marked #4) down to the body of the device. Do not attempt to remove the device without closing the lever. Excessive force on the lever of the device 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 ProGlide™ SMC device against resistance until the cause of that resistance has been determined (see Section 11.3 Single SMC DEVICE PLACEMENT section). Excessive force used to advance or torque the Perclose ProGlide™ SMC 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 ProGlide™ SMC device is encountered, withdraw the device over a 0.038" (0.97 mm) (or smaller) guidewire and reinsert the introducer sheath or use manual compression.

11. Remove the Perclose ProGlide™ 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.

13. During closure of access sites 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 ProGlide™ SMC device.

14. During closure of access sites using a procedural sheath > 8F, in the event that bleeding from the femoral access site persists after the use of the Perclose ProGlide™ SMC devices, the physician should assess the situation. Based on the physician assessment of the amount of bleeding use manual compression, compression assisted devices and / or a surgical repair to obtain hemostasis.

15. During closure of access sites using a procedural sheath > 8F, in those cases where the implanting 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 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
  • Anemia
  • Arterial stenosis / occlusion
  • Arteriovenous fistula
  • Bleeding / hemorrhage
  • Bruising / hematoma
  • Death
  • Deep vein thrombosis
  • Device entrapment
  • Device failure / malfunction / misplacement
  • Diminished pulses distal to closure site
  • Embolism
  • Hypotension / hypertension
  • Infection / sepsis
  • Inflammation
  • Intimal tear / dissection
  • Ischemia distal to closure site
  • Nerve injury
  • Numbness
  • Pain
  • Perforation
  • Pseudoaneurysm
  • Pulmonary embolism
  • Retroperitoneal hematoma / bleeding
  • Thrombus formation
  • Vascular injury
  • Vasoconstriction / vasospasm
  • Vasovagal episode
  • Wound dehiscence
IMPORTANT SAFETY INFORMATION

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