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Perclose Proglide

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*As compared to Angio-Seal, Celt ACD, ExoSeal, Mynx, Vascade. Data on file at Abbott.

 

At Abbott, we are committed to helping our customers by providing value across multiple touch points. From Complex Endovascular Interventions to PAD Awareness, Custom Solutions and Education, we are committed to bringing customized programs for your health care system needs.

AT ABBOTT, WE ARE
COMMITTED TO THE C.A.S.E.

COMPLEX

OUR ENDOVASCULAR PRODUCTS REPRESENT DEEP COLLABORATION BETWEEN SCIENTISTS, DOCTORS, AND PATIENTS OVER DECADES.

Our relentless pursuit of the next helpful idea and cutting-edge technology translates into products that can help provide better care and meaningfully impact patients’ lives. Shown below are some of our key products that support your complex case needs.

Carotid treatment: Abbott was first to market with an FDA approved carotid stent and embolic protection system. We now offer two distinct carotid stents and embolic protection systems, offering physicians a choice in systems to best meet their patients' needs.

A pioneer in closure technologies: Abbott offers suture-mediated and clip-based vessel closure products designed to facilitate secure closure of the vascular access site after coronary and peripheral catheterizations. We are also the only company to offer the Broadest Indication for both femoral arterial and venous access.

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Unique technology for treating the SFA: The Supera Peripheral Stent System is a unique class of technology that mimics the anatomy's natural movement and is an effective option for the dynamic environment of the SFA and proximal popliteal arteries. Supera is clinically proven demonstrating excellent patency in the SUPERB trial1 and has been analyzed in over 1,600 patients2 worldwide in the SUPERB trial and 16 retrospective studies.

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Guide wires: Abbott offers a broad range of peripheral guide wires to meet a variety of clinical needs. We have a legacy of over 30 years of innovation developing high performance guide wires.

AWARENESS

ABBOTT IS COMMITTED TO FIGHTING PAD AND RAISING AWARENESS -- ESPECIALLY AMONG UNDERSERVED POPULATIONS.

Visit our PAD page to learn more about our efforts on raising awareness and how we plan to address the gap in treatment.

SOLUTIONS

THE DEMANDS OF PATIENT CARE CAN BE CONSIDERABLE IN A RAPIDLY CHANGING HEALTHCARE ENVIRONMENT

Visit our resources page to learn more about reimbursement and unique programs suited to your practice.

EDUCATION

AVADEMICS, ABBOTT'S PREMIER EDUCATIONAL RESOURCE, IS YOUR COMPREHENSIVE SOLUTION FOR CUTTING-EDGE, EDUCATIONAL PROGRAMS FOR INTERVENTIONAL CARDIOLOGISTS, VASCULAR SURGEONS, AND INTERVENTIONAL RADIOLOGISTS.

Visit Avademics to learn more about educational and training programs suited to your practice.

References

1. Garcia, Lawrence A. et al., SUPERB Final 3-Year Outcomes Using Interwoven Nitinol Biomimetic Supera Stent. Catheterization and Cardiovascular Interventions 2017.
2. 1,636 patients studied, see Werner, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding nitinol stent: midterm results for the Leipzig SUPERA 500 registry, EuroIntervention 2014:10:861-868. (including Leipzig SFA, Leipzig Popliteal and S500 LL), 439 patients; Goverde, et al., AURORRA registry: Experience with high radial force interwoven nitinol stents in femoropopliteal arteries, LINC 2013, 117 patients; Molenaar, et al., Interwoven self-expanding nitinol stents for long complex SFA and popliteal lesions CWZ, LINC 2012, 178 patients; Goltz, et al., Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients with Critical Limb Ischemia, J Endovasc Ther 2012;19:450-456, 40 patients; Chan, et al., Primary stenting of femoropopliteal atherosclerotic lesions using new helical interwoven nitinol stents, JVS Feb 2014:59:384-391, 78 patients; Pacanowski, et al., RESTORE: Interwoven Stents in the Real World, The Initial United States Experience with the Use of the Supera Stent in the SFA and Popliteal Artery, LINC 2013, 147 patients; George, et al., SUPERA interwoven nitinol Stent Outcomes in Above-Knee Interventions (SAKE) study, JVIR 25.6: 954-61, 80 patients; Dumantepe, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: Midterm results, Vascular February 2015, 36 patients; Varcoe, R., A Real World Experience Using SUPERA in Long, Challenging Lesions, LINC 2015, 105 patients; Brescia, et al., Stenting of femoropopliteal lesions using interwoven nitinol stents, J Vasc Surg. 2015 Mar 6, 38 patients; Mussa, et al., The SUPERA stent for superficial femoral artery lesions even with calcification, Charing Cross 2015, 41 patients; Lojedo Vicent, et al., Experiencia inicial en la colocacion de endoprotesis Supera en eltratmiento de la patologia arterial en sector femoropopliteo , XIV Congreso de la SERVEI 2015, 29 patients; Palena, et al., SUPERSUB Trial: 1-yr outcomes of Supera Subinitimal stenting in CLI patents, LINC 2016, 34 patients; Rosenfield, K., et al., Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries 12 Month Results of the SUPERB Trial, Circ Cardiovasc Interv. 2015, 264 patients.

IMPORTANT SAFETY INFORMATION

Rx Perclose ProGlide® Suture-Mediated Closure (SMC) System

INDICATIONS

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.

CAUTION

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.

CONTRAINDICATIONS

There are no known contraindications to the use of this device. Attention is drawn to the WARNINGS and PRECAUTIONS sections.

WARNINGS

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.

PRECAUTIONS

1. Prior to use, inspect the Perclose ProGlide SMC 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.

2. As with all catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the Perclose ProGlide SMC 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 vessel.

4. Do not deploy the Perclose ProGlide SMC device at an angle greater than 45 degrees, as this may cause a cuff miss.

5. There are no reaccess restrictions if previous access site repairs were achieved with Abbott Vascular SMC devices.

6. If significant blood flow is present around the Perclose ProGlide SMC device, do not deploy needles. Remove the Perclose ProGlide SMC device over a 0.038" (0.97mm) (or smaller) guidewire and insert an appropriately sized introducer sheath.

7. When pushing the plunger assembly to advance the needles, stabilize the device to ensure the device does not twist or move forward during deployment. Twisting the device could lead to needle deflection resulting in a cuff miss. Do not use excessive force or repeatedly push the plunger assembly. Excessive force on the plunger during deployment could potentially cause breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.

8. Do not apply excessive force to the lever when returning the foot to its original position (marked #4) down to the body of the device. Do not attempt to remove the device without closing the lever. Excessive force on the lever of the device or attempting to remove the device without closing the lever could cause breakage of the device and / or lead to vessel trauma, which may necessitate intervention and / or surgical removal of the device and vessel repair.

9. Do not advance or withdraw the Perclose ProGlide SMC device against resistance until the cause of that resistance has been determined (see Section 11.3 Single SMC DEVICE PLACEMENT section). Excessive force used to advance or torque the Perclose ProGlide SMC device should be avoided, as this may lead to significant vessel damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.

10. If excessive resistance in advancing the Perclose ProGlide SMC device is encountered, withdraw the device over a 0.038" (0.97 mm) (or smaller) guidewire and reinsert the introducer sheath or use manual compression.

11. Remove the Perclose ProGlide 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. In using this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing damage due to application of surgical instruments such as clamps, forceps or needle holders.

13. During closure of access sites using a 5 – 8F procedural sheath, use manual compression in the event that bleeding from the femoral access site persists after the use of the Perclose ProGlide SMC device.

14. During closure of access sites using a procedural sheath > 8F, in the event that bleeding from the femoral access site persists after the use of the Perclose ProGlide SMC devices, the physician should assess the situation. Based on the physician assessment of the amount of bleeding use manual compression, compression assisted devices and / or a surgical repair to obtain hemostasis.

15. During closure of access sites using a procedural sheath > 8F, in those cases where the implanting physician is not a vascular surgeon, it is recommended that a vascular surgeon or a surgeon with vascular training be available during the procedure to perform any necessary surgical intervention.
 

POTENTIAL ADVERSE EVENTS

Potential adverse events associated with use of suture mediated closure devices may include, but are not limited to, the following: • Allergic reaction or hypersensitivity to device components • Anemia • Arterial stenosis / occlusion • Arteriovenous fistula • Bleeding / hemorrhage • Bruising / hematoma • Death • Deep vein thrombosis • Device entrapment • Device failure / malfunction / misplacement • Diminished pulses distal to closure site • Embolism • Hypotension / hypertension • Infection / sepsis • Inflammation • Intimal tear / dissection • Ischemia distal to closure site • Nerve injury • Numbness • Pain • Perforation • Pseudoaneurysm • Pulmonary embolism • Retroperitoneal hematoma / bleeding • Thrombus formation • Vascular injury • Vasoconstriction / vasospasm • Vasovagal episode • Wound dehiscence

IMPORTANT SAFETY INFORMATION

RxSupera® Peripheral Stent System

INDICATIONS

The Supera Peripheral Stent System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm.

CONTRAINDICATIONS

The Supera Peripheral Stent System is contraindicated in:

  • patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
  • patients who cannot receive antiplatelet or anticoagulation therapy. Based on in vivo thrombogenicity testing, the device should not be used in patients who cannot be anticoagulated as there may be some thrombus formation in the absence of anticoagulation.

WARNINGS
 

  • This device is intended for single-use only. Do not reuse. Do not resterilize. Do not use if the package is opened or damaged.
  • Use this device prior to the “Use By” date as specified on the device package label. Store in a dry, dark, cool place.
  • DO NOT use if it is suspected that the sterility of the device has been compromised.
  • Persons with known hypersensitivities to Nitinol and / or its components (e.g. nickel titanium) may suffer an allergic reaction to this implant.
  • Administer appropriate antiplatelet therapy pre- and post-procedure.
  • Careful attention should be paid when sizing and deploying the stent to prevent stent elongation. In the SUPERB clinical study, stent elongation was associated with a decrease in patency at 12 months.

PRECAUTIONS

The Supera Peripheral Stent System should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device.

  • The long-term safety and effectiveness of the Supera Peripheral Stent System has not been established beyond three years.
  • The safety and effectiveness of the Supera Peripheral Stent System has not been established in patients who:
    • are less than 18 years old
    • are pregnant or lactating
    • have in-stent restenosis of the target lesion
    • have known hypersensitivity to any component of the stent system (e.g., nickel)
    • cannot tolerate contrast media and cannot be pre-treated
    • have uncontrolled hypercoaguability and / or other coagulopathy
  • This device is not designed for use with contrast media injection systems or power injection systems.
  • The flexible design of the Supera stent may result in variation in the deployed stent length.

Magnetic Resonance Imaging (MRI)

A patient with this device can be scanned safely only under specific conditions. Failure to follow the conditions may result in severe injury.

Non-clinical testing has demonstrated the Supera Stents are

MR Conditional for lengths up to 250 mm. A patient with this stent can be scanned safely, immediately after placement, under the following conditions:

  • Static magnetic field of 1.5 or 3.0 Tesla
  • Highest spatial gradient magnetic field of 2,500 Gauss/cm or less
  • Maximum MR whole-body-averaged specific absorption rate (SAR) of
    • 2 W/kg for landmarks (i.e. center of RF coil) above the umbilicus
    • 1 W/kg for landmarks below the umbilicus and above the mid-thigh
    • 0.5 W/kg for landmarks below the mid-thigh
    for 15 minutes of scanning (per pulse sequence), operating in the Normal Operating Mode (i.e., MR system mode of operation where there is no physiological stress to the patient). The legs of the patient should not be touching during the procedure.

POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to:

  • Abrupt closure
  • Allergic reaction (contrast medium; drug; stent material)
  • Amputation or limb loss
  • Aneurysm or pseudoaneurysm in vessel or at vascular access site
  • Angina or coronary ischemia
  • Arrhythmia (including premature beats, bradycardia, atrial or ventricular tachycardia, atrial or ventricular fibrillation)
  • Arteriovenous fistula
  • Bleeding complications requiring transfusion or surgical intervention
  • Death
  • Detachment of a system component or implantation in an unintended site
  • Embolization, arterial or other (e.g. air, tissue, plaque, thrombotic material, or stent)
  • Emergent surgery
  • Fever
  • Abrupt closure
  • Allergic reaction (contrast medium; drug; stent material)
  • Amputation or limb loss
  • Aneurysm or pseudoaneurysm in vessel or at vascular access site
  • Angina or coronary ischemia
  • Arrhythmia (including premature beats, bradycardia, atrial or ventricular tachycardia, atrial or ventricular fibrillation)
  • Arteriovenous fistula
  • Bleeding complications requiring transfusion or surgical intervention
  • Death
  • Detachment of a system component or implantation in an unintended site
  • Embolization, arterial or other (e.g. air, tissue, plaque, thrombotic material, or stent)
  • Emergent surgery
  • Fever
  • Hematoma or hemorrhagic event, with or without surgical repair
  • Hyperperfusion syndrome
  • Hypertension / Hypotension
  • Infection
  • Myocardial infarction
  • Pain (leg, foot, and/or insertion site)
  • Partial stent deployment
  • Peripheral nerve injury
  • Pulmonary embolism
  • Renal failure or insufficiency
  • Restenosis of vessel in stented segment
  • Shock
  • Stent malapposition or migration, which may require emergency surgery to remove stent
  • Stent strut fracture
  • Thrombosis or occlusion
  • Stroke
  • Transient ischemic attack
  • Venous thromboembolism
  • Vessel dissection, perforation or rupture
  • Vessel spasm or recoil
  • Worsening claudication or rest pain

Prior to use, please reference the Instructions for Use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions, and adverse events.

IMPORTANT SAFETY INFORMATION

AP2946412-WBU Rev. A

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