The studies shown below are examples of the safety and benefits that Perclose ProGlide™ Suture-Mediated Closure (SMC) System may provide patients requiring small or large sheaths in arterial or venous access procedures.
A study showing ambulation times, costs and patient satisfaction between the two methods of hemostasis approaches.
Sekhar, Aravind., et al. Femoral arterial closure using ProGlide™ is more efficacious and cost-effective when ambulating early following cardiac catheterization.
International Journal of Cardiology: Heart and Vasculature 13 (2016) 6-13.
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.
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.
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.
The primary endpoint was time-to-ambulation (TTA) following device closure.
| 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 |
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 cost | $278.2 ± 77.4 | $41.6 ± 22.4 |
| Post-procedural cath lab holding | $308.5 ± 78.8 | $1,190.8 ± 333.6 |
| Total adjusted nursing costs | $99.1 ± 41.1 | $389.5 |
| Hospital adjusted in-patient expenses | $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 |
Perclose ProGlide™ SMCS helps reduce severe levels of patient discomfort as compared to manual compression.
An overview of the Least Invasive Fast-Track EVAR (LIFE) Registry
Krajcer, Zvonimir. Fast-Track Endovascular Aortic: Final Results from the Prospective LIFE Registry.
VIVA 2016
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.
Prospective, non-randomized, multi-center post-market study of 250 patients at 35 U.S. centers
Major adverse event within 30 days (10.4% target performance goal)
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 |
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 | Cutdown $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 |
*Access cost for Bilateral PEVAR is higher due to cost of closure devices
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.
MAT-2103458 v2.0
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 femoral 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 v4.0
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 femoral 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 v4.0
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