Abbott is committed to providing hemostasis management solutions to help patients and hospitals thrive. Time management, patient and staff flow, hospital costs, and throughput can all impact overall hospital efficiency.
Our hemostasis management portfolio aims to drive hospital efficiency through:
The FemoStop™ Compression Assist Device uses hands-free compression of the femoral artery or vein to offer precise hemostasis management and patient comfort.
*As compared to Angio-Seal‡, ExoSeal‡, Celt ACD, MANTA‡, Mynx‡, Vascade‡, Data on file at Abbott.
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:
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.
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.
There are no known contraindications to the use of this device. Attention is drawn to the WARNINGS and PRECAUTIONS sections.
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.
Potential adverse events associated with use of suture mediated closure devices may include, but are not limited to, the following:
The StarClose SE™ Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5F or 6F procedural sheath.
The StarClose SE™ Vascular Closure System is indicated for use to allow patients who have undergone diagnostic endovascular catheterization procedures to ambulate and be eligible for discharge as soon as possible after device placement.
The StarClose SE™ Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation in patients who have undergone interventional endovascular catheterization procedures utilizing a 5F or 6F procedural sheath.
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 therapeutic catheterization procedures and who has been trained by an authorized representative of Abbott Vascular.
Prior to use, the operators must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.
The StarClose SE™ Vascular Closure System is contraindicated for use in patients with known hypersensitivity to nickel-titanium.
Do not use the StarClose SE™ Vascular Closure 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 StarClose SE™ Vascular Closure System and accessories are intended for single use only.
Do not use the StarClose SE™ Vascular Closure 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 StarClose SE™ Vascular Closure 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.
Do not use the StarClose SE™ Vascular Closure System if the puncture is through the posterior wall or if there are multiple punctures, since such punctures may result in a retroperitoneal hematoma.
Do not use the StarClose SE™ Vascular Closure System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, 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.
1. The StarClose SE™ Vascular Closure System should be used only by operators trained in diagnostic and interventional catheterization procedures who have been certified by an authorized representative of Abbott Vascular Inc.
2. The StarClose SE™ Vascular Closure System is provided sterile and non-pyrogenic in unopened undamaged packaging. Products are sterilized with ethylene oxide and intended for single use only. Do not resterilize. Store in a cool, dry place.
3. Prior to use, inspect the StarClose SE™ Vascular Closure 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.
4. As with catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the StarClose SE™ Vascular Closure System. Employ appropriate groin management post procedure and post hospital discharge to prevent infection.
5. Use a single wall puncture technique. Do not puncture the posterior wall of the artery.
6. Do not use the StarClose SE™ Vascular Closure System to close vessels with diameters less than 5 mm.
7. Do not deploy the Clip in areas of calcified plaque.
8. The StarClose SE™ Vascular Closure System can be used ONLY with the StarClose Exchange System (included in the StarClose SE™ Vascular Closure System packaging).
9. Do not advance or withdraw the StarClose SE™ Vascular Closure Device against resistance until the cause of that resistance has been determined. Excessive force used to advance or torque the StarClose SE™ device should be avoided, as this may lead to significant vessel damage and/or breakage of the device, which may necessitate interventional and/or surgical removal of the device and vessel repair.
Potential adverse events that could be associated with the use of this device include:
Major Vascular Complications • Vascular Injury Requiring Repair • Surgery • Angioplasty • Ultrasound Guided Compression • Thrombin Injection or Other Percutaneous Procedure • New Ipsilateral Lower Extremity Ischemia • Access Site-related Bleeding Requiring Transfusion • Access Site-related Infection Requiring Intravenous Antibiotics or Prolonged Hospitalization • Access Site-related Nerve Injury Requiring Intervention • Death Minor Vascular Complications • Pseudoaneurysm • Arteriovenous Fistula • Hematoma (≥ 6 cm) • Late Access Site-related Bleeding • Transient Lower Extremity Ischemia • Ipsilateral Deep Vein Thrombosis • Transient Access Site-related Nerve Injury • Access Site-related Vessel Injury • Access Site Wound-related Dehiscence • Access Site-related Bleeding Requiring ≥ 30 minutes to Re-achieve Hemostasis • Localized Access Site Infection Treated with IM or Oral Antibiotics • UADE
Prior to use, please reference the Instructions for Use at eifu.abbottvascular.com for more information on indications, contraindications, warnings, precautions, and adverse events.
The Prostar™ XL PVS System is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths. (Refer to PRECAUTIONS, SPECIAL PATIENT POPULATIONS sections).
None known.
The outer pouch of the Prostar™ XL PVS System and the individual accessories provides the sterile barrier.
Do not use the Prostar™ PVS System or accessories if the packaging or sterile barrier have been previously opened or damaged, or if the components appear to be damaged or defective.
DO NOT RESTERILIZE OR REUSE. The Prostar™ XL PVS System and accessories are intended for single use only. Do not use the Prostar™ XL PVS System if the puncture site is proximal to the inguinal ligament as this may result in a retroperitoneal hematoma.
1. The Prostar™ XL PVS device and accessories should only be used by physicians (or other healthcare professionals authorized by or under the direction of such physicians) after they have been trained in the use of the Prostar™ XL PVS System and accessories, e.g., participation in a Prostar™ XL PVS System training program or equivalent.
2. Observe sterile technique at all times when using the Prostar™ XL PVS 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 artery.
4. Adequate knot security requires accepted surgical technique as warranted by surgical circumstances and the experience of the operator.
5. There are no reaccess restrictions if previous arteriotomy repairs were achieved with an Abbott Vascular Suture Mediated Device.
6. Do not insert the Prostar™ XL device into the femoral artery at an angle greater than 45 degrees to the longitudinal plane of the artery.
7. Do not advance or withdraw the Prostar™ XL device against resistance until the cause of that resistance has been determined (see CLINICAL PROCEDURE-Device Placement section). Excessive force used to advance or torque the Prostar™ XL device should be avoided as it may lead to significant arterial damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and arterial repair.
8. If excessive resistance in advancing the Prostar™ XL device is encountered, withdraw the Prostar™ XL device over a 0.038” (or smaller) guide wire and reinsert the introducer sheath or use conventional compression therapy.
9. In the event suture breakage occurs after an initial knot has been tied, care should be taken to avoid excessive force if the reintroduction of the Prostar™ XL device or introducer sheath is required. Any resistance to introduction should result in advancement of an introducer sheath small enough to be introduced without undue force.
10. If significant blood flow is evident through or around the barrel of the Prostar™ XL device, do not deploy needles. Remove the Prostar™ XL device over a 0.038” (or smaller) guide wire and insert an appropriately sized introducer sheath.
11. Remove the Prostar™ XL 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.
12. Do not attempt to re-deploy Prostar™ XL needles after the needles have been “backed-down” into the sheath (refer to the TECHNIQUE FOR NEEDLE BACK-DOWN section).
13. In the event bleeding from the femoral access site persists after the use of the Prostar™ XL device and accessories, use conventional compression therapy.
The following adverse events have been reported and may occur include • Device Malfunction • Device Complication • Vascular Repair • Ultrasound Guided Compression • Transfusion • Infection Requiring IV Antibiotics • Hematoma > 6 cm • AV Fistula • Nerve Injury • Pseudoaneurysm
Prior to use, please reference the Instructions for Use at eifu.abbottvascular.com for more information on indications, contraindications, warnings, precautions, and adverse events.
The FemoStop™ Femoral Compression System is indicated for use in the compression of the femoral artery or vein after vessel cannulation and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm.
Possible adverse effects that may result from the use of this device include but are not limited to:
Additional warnings and precautions for ultrasound-guided compression repair of a pseudoaneurysm in the femoral artery
MAT-2009415 v2.0