For greater peace of mind.
The studies shown below are examples of the safety and benefits that Perclose ProStyle™ Suture-Mediated Closure and Repair (SMCR) System may provide patients who have undergone cardiac arrhythmia treatments with multiple common femoral venous access sites.
This trial was a prospective, single arm, multi-center, descriptive study of 36 patients enrolled from September, 2021 to May 2022. Femoral duplex ultrasound is not routinely utilized during ablation procedures and is often only used when access-site related complications are visible and/or symptomatic. To evaluate the safety of multiple access site closure in a single vein with PercloseTM, patients underwent duplex ultrasound to assess the presence of asymptomatic or non-visible complications.
All subjects underwent routine cardiac ablations as standard of care. A total of 36 patients were enrolled with an average of 3.5 access sites ranging in size from 8-15F. 14 patients underwent cryoablation only, 21 patients underwent radiofrequency ablation only, and 1 patient underwent both types of ablation procedures. Patients received a femoral vein duplex ultrasound of their access sites at discharge and, for those with asymptomatic or non-visible complications, a second duplex ultrasound at 30 day follow up.
Major or minor vascular complications detected by scheduled duplex ultrasound at discharge and at 30 days in subjects with asymptomatic/non-visible complications.
Freedom from major access site-related complications deteted symptomatically or by duplex ultrasound at discharge and at 30 days
to hemostasis per patient with 3.5 access sites on average
Perclose success rate per access site
of minor complications were confirmed resolved at 30 days by duplex ultrasound
*Median reported
Retrospective, chart review, subject-level study of 434 atrial fibrillation patients from October 2017 to November 2020 to evaluate differences in rates of vascular and bleeding complications when comparing PercloseTM devices, manual compression, and Fo8, to achieve hemostasis post ablation procedure.
Charts of 434 atrial fibrillation patients were reviewed (64% cryoablation, 36% radiofrequency). PercloseTM was utilized with 75 of the patients while a 156 were treated with manual compression and 203 with Figure of 8. Per institutional protocol, the right femoral vein was used for the first three access sites, with additional access sites placed in the left femoral vein. There was a mean of 3.6 access sites per subject. Performance and safety endpoints were evaluated in hospital – there was no 30 day follow up in this study.
Freedom from femoral vein access-related major vascular complications at discharge. Additional parameters included time to hemostasis and time to ambulation.
Freedom from access site-related complications at discharge
Minor complication rate
Time to hemostasis and ambulation compared to manual compression
Prospective, randomized controlled trial to evaluate the safety and effectiveness of PercloseTM in comparison with manual compression. A total of 109 patients (55 Perclose patients*, 54 manual compression patients) were enrolled across three sites from January, 2020 to December, 2020.
Subjects underwent routine ablation for AF as standard of care (66% cryoablation, 34% radiofrequency) and were followed through for 30 days before exiting the trial. All access sites in the closure arm were treated with one PercloseTM, regardless of sheath size as standard. 52 out of the 53 closure patients had at least one sheath larger than 8F with an average sheath size of 10.24F and sheath sizes ranging from 7-16F.
The primary safety endpoint was freedom from femoral vein access-related major vascular complications. Secondary endpoints included time to hemostasis and time to ambulation, frequency of access-site related complications, pain, need for post-procedure narcotics, subject satisfaction, cost and overall resource utilization.
Freedom from major access site-related complications up to 30 days
Success rate per access site
Time to hemostasis and ambulation compared to manual compression
*Of the 55 subjects enrolled, two were randomized without procedure, therefore, only 53 subjects were assessed for safety endpoints to 30 days
Retrospective, single-arm, subject-level study to evaluate the safety and effectiveness of PercloseTM devices in closure of multiple access sites of the ipsilateral femoral vein following atrial fibrillation (AF). Study included 519 atrial fibrillation patients from November 2016 – March 2020 who had at least one access site closed with a Perclose device and were discharged the same day, with 30-day follow up.
Right femoral vein was used for access and closure per the site standard with an average of 3.6 access sites per vein. Post-close technique with a single device was used for all access sites, including those above 8F. Access sites ranged from 4-12F.
Freedom from femoral vein access-related major vascular complications at 30 days post-procedure.
Freedom from Major Access Site-Related Complications
PercloseTM device used with post-close technique for all >8F sheaths
Hemostasis for large-sized venous access sites is commonly achieved via manual compression (MC) or by a subcutaneous figure-of-eight stitch followed by prolonged application of a compression bandage (usually ≥12 hours). However, this combination leads to patient discomfort and extended immobilization, which in turn may lead to additional complications.
Evaluate the safety and performance of the Perclose ProGlide™ SMC in the closure of the venous access site in subjects treated with a large-caliber femoral vein sheath (24F OD).
A retrospective analysis was performed to evaluate the safety and effectiveness of the Perclose ProGlideTM SMC in closing large-sized venous access sites through a retrospective data collection from the EVEREST II /REALISM Continued Access Registry Study (REALISM). The retrospective analysis included subjects in whom Perclose ProGlideTM was used as the primary method for large bore venous access-site closure during the MitraClip index procedure with a 24F OD vascular sheath.
Rate of freedom from major femoral vein access-site related complication at 30 days post-procedure, compared to pre-defined clinical acceptance criteria (≥ 90%).
freedom from major femoral vein access site-related complications at 30 days
Major complication rate observed with use of 24F OD sheath
mean time to hemostasis for patients who received the Perclose ProGlide™ SMC System only
**Source: Perclose™ ProStyle™ SMCR System Instructions for Use (IFU). Refer to IFU for additional information.
MAT-2308139 v1.0
Indications:
The Perclose™ ProStyle™ Suture-Mediated Closure and Repair 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 indicated for closing the common femoral vein in single or multiple access sites per limb.
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 arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
For access sites in the common femoral vein using 5F to 24F sheaths. For venous sheath sizes greater than 14F, 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 or venous 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 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:
Potential Adverse Events:
Potential adverse events associated with use of vessel closure devices may include, but are not limited to, the following:
MAT-2100368 v3.0
Indications:
The Perclose ProGlide™ Suture-Mediated Closure 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 indicated for closing the common femoral vein in single or multiple access sites per limb.
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 arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
For access sites in the common femoral vein using 5F to 24F sheaths. For venous sheath sizes greater than 14F, 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 ProGlide™ SMC 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 ProGlide™ SMC System is 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 vessel.
Do not use the Perclose ProGlide™ SMC System in arterial or venous 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 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 vessel.
Precautions:
Potential Adverse Events:
Potential adverse events associated with use of vessel closure devices may include, but are not limited to, the following:
MAT-2100358 v3.0
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