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STRUCTURAL INTERVENTIONS

AMPLATZER™ TALISMAN™
PFO OCCLUDER

Effective PFO closure is made easier with the Amplatzer™ Talisman™ PFO Occluder.1 For patients who have experienced a PFO-associated stroke, clinical trials have shown that they can benefit from PFO closure.2-4 This minimally-invasive procedure significantly reduces the risk of recurrent ischemic stroke and offers an excellent safety profile.

THE PIONEER 
IN PFO CLOSURE1

As the device that created the category, the Amplatzer™ PFO Occluder has sustained leadership over decades of use by pursuing clinical evidence to become the first device supported by positive PFO trial results.2

Today, it is the most-studied device of its kind, with over 180,000 patients treated worldwide.1 And our clinical evidence is unmatched, thanks to the largest-ever trial for PFO closure, boasting 5,810 patient-years of data.2

Amplatzer Talisman PFO Occluder is the first device supported by positive patent foramen ovale trial results

About the Amplatzer™ Talisman™
PFO Occluder

With the Amplatzer™ Talisman™ PFO Occluder, the device you know and trust just got better. It is built on the proven Amplatzer PFO closure technology and the Amplatzer Trevisio™ Delivery System, with key enhancements to make it our most advanced and easy-to-use PFO closure device yet:

  • We've added a 30 mm device so you have the complete PFO portfolio for every case
  • The occluder comes assembled and ready to use, simplifying preparation and enhancing ease-of-use

The PFO Occluder trusted by thousands of physicians around the world1

180K+

Global implants1


WE SET THE STANDARD

  • Pioneered treatment with a PFO-specific device
  • Available in over 80 countries around the world

5,810

PATIENT-YEARS OF DATA2


WE RAISE THE BAR

  • With the landmark RESPECT trial,2 we had the most extensive patient follow-up, almost 2x more than other PFO trials
  • RESPECT was also the only trial to include patients on anticoagulation therapy, a real-world cross-section of patients

990

PATIENTS IMPLANTED WITH DEVICE IN RCTS2-4


WE DEMONSTRATE EXCELLENCE

  • ZERO device erosions, thrombus, or embolization events in 6 published trials with 990 patients
  • 94.2% effective closure rate at 6 months

How to implant the Amplatzer Talisman 
PFO Occluder

Watch the Amplatzer™ Talisman™ PFO Occluder implant procedure video.

The Amplatzer™ Talisman™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude other causes of ischemic stroke.

Among patients with a PFO who have had an ischemic stroke, the Amplatzer Talisman PFO Occluder has demonstrated excellent safety and effectiveness in reducing the risk of recurrent stroke.

Key benefits for PFO patients

59% RELATIVE RISK REDUCTION IN RECURRENT ISCHEMIC STROKE5

LESS ANXIETY, MORE PEACE-OF-MIND

For patients who have experienced a PFO-associated stroke, the thought of a recurrence can generate anxiety. Determining and delivering the most effective treatment soon after a stroke is critically important to provide these patients with peace-of-mind.

For patients and caregivers wanting to learn more about PFO-associated stroke and PFO closure, www.PFOstroke.com is an excellent resource, including:

  • All about PFO and stroke
  • Understanding PFO treatment options
  • Information about the Amplatzer Talisman PFO Occluder
  • Resources, including FAQ and brochures
     
Christine Lee - Amplatzer PFO

One week after her PFO closure, Christine was back on the treadmill running 5 miles an hour - (Christine Lee - USA)

After Christine Lee’s stroke at age 33, her neurologist ordered a transesophageal echocardiogram to look for a PFO. Nearly 6 months after her first stroke, she had a TIA. Her neurologist then made a referral to an interventional cardiologist, and he recommended she get the PFO closure procedure within 7 days.

Hear about her experience
“I’ve had so many emails from readers who say their neurologist won’t make that referral to an interventional cardiologist. They just won’t. They want to know the name of my cardiologist, because they’re so desperate.”

READ MORE

Find a Talisman PFO Certified
Physician Near Me

Use this tool to refer a patient or consult with a certified implanting physician near you.

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FEATURES

Advancing the Gold Standard in PFO Closure

For decades, interventional cardiologists have trusted the Amplatzer™ PFO Occluder for ease-of-use, safety, and excellent clinical outcomes.2 With our latest addition, the Amplatzer™ Talisman™ PFO Occlusion System, the easy-to-use just got easier:

  • We've added a 30mm device so you have the complete PFO portfolio for every case.
  • The occluder comes assembled and ready to use, streamlining preparation and enhancing the user experience.
Amplatzer Talisman PFO Occlusion System features pre-attached occluder and re-designed hemostasis valve

Often Imitated,
Never Matched

Unique design features set the Amplatzer Talisman PFO Occluder apart from the rest.

Often Imitated, Never Matched

*Only the 18 mm size is not asymmetric.
†Effective closure.

Amplatzer Talisman PFO Occluder demonstrated over 94 percent closure rate in clinical trial

Minimizing Complexity in PFO Closure

SIMPLIFIED
PREP

Occluder comes assembled to Trevisio™  delivery cable, ready to use
 

Amplatzer Talisman PFO Occluder comes assembled to Trevisio delivery cable, ready to use

RECAPTURABLE AND REPOSITIONABLE

Self-expanding discs align to the PFO without an additional “locking” step and can be adjusted for ideal placement
 

Amplatzer Talisman PFO Occluder is recapturable and repositionable for better PFO closure

LOW-PROFILE
DELIVERY

8 F and 9 F introducer sheaths enable treatment of patients with smaller vasculature

Amplatzer Talisman PFO Occluder offers options for patients with smaller vasculature
Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use

NEW VERSION AVAILABLE
GET THE AMPLATZER PORTFOLIO APP

The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
 

App Store
Google Play

MAT-2008367 v6.0 | Item approved for U.S. use only.

References
  1. Data on file at Abbott.
  2. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-1032. doi: 10.1056/NEJMoa1610057.
  3. Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377:1033-1042. doi: 10.1056/NEJMoa1707404.
  4. Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011-1021 and supplementary appendix. doi: 10.1056/NEJMoa1705915.
  5. Messé SR, Gronseth GS, Kent DM, et al. Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology. Neurology. 2020;94(20):876-885. doi:10.1212/WNL.0000000000009443
Important Safety Information
  • AMPLATZER™ TALISMAN™ PFO OCCLUDER
  • AMPLATZER™ TALISMAN™ DELIVERY SHEATH

  • Rx Only

    AMPLATZER™ TALISMAN™ PFO OCCLUDER

    INDICATION FOR USE


    The Amplatzer™ Talisman™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude other causes of ischemic stroke.

    CONTRAINDICATIONS

    Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained; Patients with intra-cardiac thrombus, mass, vegetation, or tumor; Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size; Patients with anatomy in which the required Amplatzer™ Talisman™ PFO device size would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins; Patients with another source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum; Patients with active endocarditis or other untreated infections; Patients who are unable to tolerate intra-procedural anticoagulation or post-procedural anti-platelet therapy.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus; Allergic reaction/toxic effect due to: anesthesia, contrast media, medication, or metal; Arrhythmia; Arteriovenous fistulae; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Death; Deep vein thrombosis; Device embolization; Device erosion; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hematoma; Hypertension/hypotension; Infection; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Pain; Pericardial effusion; Pericarditis; Peripheral embolism; Pseudoaneurysm; Pulmonary embolism; Reintervention for residual shunt/device removal; Stroke; Transient ischemic attack; Thrombus formation; Valvular regurgitation; Vascular access site injury; Vessel perforation.

  • AMPLATZER™ TALISMAN™ DELIVERY SHEATH
    INDICATION FOR USE

    The Amplatzer™ Talisman™ Delivery Sheath is indicated to provide a pathway through which an Amplatzer™ PFO Occluder is introduced for patent foramen ovale closure.

    CONTRAINDICATIONS

    • None known.

    WARNINGS

    • This device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
    • Do not use this device if the sterile package is open or damaged. Inspect all components before use. Do not use if the package or items appear to be damaged or defective.
    • DO NOT use the Amplatzer™ Talisman™ Delivery Sheath after the Use-by date stated on the package label.
    • This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should determine which patients are candidates for procedures that use this device.
    • Use a hemostasis valve to impede blood backflow during the implant procedure.

    PRECAUTIONS

    • The physician should exercise clinical judgment in situations that involve the use of antithrombotic drugs before, during, and/or after the use of the delivery sheath.
    • Use caution and rely on imaging guidance when advancing the sheath and dilator to minimize the risk of cardiovascular injury or interference with previously implanted medical devices. Whenever possible, advance the sheath and dilator over a guidewire.
    • Do not attempt to use a guidewire larger than the maximum diameter specified in the Directions for Use.
    • Do not use a power injection system to put contrast solution through the sheath.
    • Remove the dilator and sheath from the patient slowly to prevent an ingress of air.

    POTENTIAL ADVERSE EVENTS

    • Potential adverse events that may occur during or after a procedure using this delivery sheath may include, but are not limited to:
    • Allergic reaction/toxic effects due to hypersensitivity to contrast agent, anesthesia, device materials, or drugs used to minimize blood clot formation
    • Arrhythmia
    • Arteriovenous fistulae
    • Bleeding
    • Cardiac perforation
    • Cardiac tamponade
    • Cardiovascular injury
    • Death
    • Dissection
    • Embolism (air, foreign body, and peripheral)
    • Hematoma
    • Infection
    • Myocardial infarction
    • Pericardial effusion
    • Thromboembolism
    • Thrombosis
    • Vascular access site injury

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