The Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System provides the secure finish to your successful procedure, helping you to deliver better quality care to your patients:
Learn more about how you can finish your procedure with confidence with the Perclose™ ProStyle™ SMCR System.
The electrophysiologists (EPs) performing atrial fibrillation ablations may choose the Perclose™ ProStyle™ SMCR System for greater efficiency in the EP lab. Among vascular closure devices, Perclose™ ProStyle™ closure can offer benefits for the EP lab including:
The Perclose™ ProStyle™ vascular closure device has the broadest indication* for venous and arterial sheaths. In addition, this VCD also has a proven and trusted track record from more than 12 million repairs.3
Prior to adopting Perclose™ ProStyle™ SMCR System, EPs completing an atrial fibrillation ablation or other procedures may find that patients require:
The Perclose™ ProStyle™ closure device transforms an otherwise lengthy patient recovery to a much shorter recovery time, which in turn leads to a positive patient experience:
†Time to Ambulation: Per the IFU, patients may be ambulated 2 hours after the Perclose™ ProStyle™ SMCR System procedures using 5-8F sheaths. For sheaths > 8F, ambulation time may be 2 hours or more based on physician’s discretion.
The rapid time to hemostasis allows EPs to verify the status of the closure while the patient is still under their care, enhancing confidence in the entire procedure from access to closure. Moreover, it’s potentially beneficial to the EP lab and hospital staff when patients are quickly ambulating, freeing up beds, and discharged the same day.
The use of Perclose™ ProStyle™ Suture-Mediated Closure and Repair System can help:
SOURCE: S. Verma. Adopting a Strategy of Early Ambulation and Same-Day Discharge for Atrial Fibrillation Ablation Cases - EP Lab Digest - May 2019.
The Perclose™ ProStyle™ closure device achieves rapid hemostasis of femoral access sites by approximating the edges of the vessel wall with a surgical suture. The benefits of suture-mediated repair include promoting primary intention healing with less scarring14 and decreased time to hemostasis, ambulation, and patient discharge.15,16
Using a VCD has several advantages given the following factors during EP procedures such as AF ablations:
All of these issues are mitigated when using the Perclose™ ProStyle™ closure device.
With the Perclose™ ProStyle™ device you can achieve and confirm complete hemostasis on the table with a suture-mediated repair of the access site. Other advantages of the Perclose™ ProStyle™ SMCR System include:
Find out more about primary healing with the Perclose ProStyle™ vessel closure device.
No, there is only one Perclose™ ProStyle™ SMCR System. Multiple Perclose™ ProStyle™ devices can be used, if necessary, for large-bore vascular closure.
Because this device achieves immediate and durable hemostasis, patients can be mobilized and ambulated after approximately two hours (at the physician's discretion). Some facilities have successfully implemented a Same-Day Discharge strategy when using the Perclose™ ProStyle™ SMCR System.
It achieves hemostasis by approximating the edges of the vessel wall with a surgical suture, allowing primary intention healing to begin. Primary intention healing minimizes scarring and allows for immediate reaccess if needed. View primary intention healing images with vessel closure device.
The "Pre-Close" Technique involves the Perclose™ ProStyle™ suture being placed around the access site before the index procedure, and it is required before using sheath sizes > 8F.
See Deployment and Instructions for Use for additional information.
Each Perclose™ ProStyle™ device has a polypropylene monofilament suture with a pre-formed knot which has a tensile strength high enough to approximate the edges of the vessel wall. This suture can snap with quick and jerky movements. You can avoid suture break with the use of slow, consistent, increasing tension. Refer to the Tips and Technique: Suture Break section of Deployment.
Please refer to the Tips and Technique: Cuff Miss section of Deployment.
Visit the official Perclose™ ProStyle™ website for more information on the features, deployment, clinical data, Perclose™ ProStyle™ videos, and ordering information related to Perclose™ ProStyle™ SMCR System.
*As compared to Angio-Seal,‡ ExoSeal,‡ FemoSeal,‡ InClosure,‡ MANTA,‡ Mynx,‡ PerQseal,‡ Vascade,‡ Velox CD,‡ X-Seal‡. Data on file at Abbott.
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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:
Potential Adverse Events: Potential adverse events associated with use of suture mediated closure devices may include, but are not limited to, the following:
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Precautions
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