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:
For EP labs, click here to discover how Perclose™ ProStyle™ can improve EP lab workflow and enhance patient experience.
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.
Primary Wound Healing with Suture Repair
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:
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.
Perclose™ ProStyle™ device
Perclose ProStyle Suture Trimmer
*As compared to Angio-Seal, MANTA, Celt ACD, ExoSeal, Mynx, Vascade. Data on file at Abbott.
MAT-2102358 v1.0
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:
MAT-2100368 v2.0
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Precautions
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