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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 data show they can benefit from PFO closure, with this minimally invasive procedure significantly reducing the risk of recurrent ischemic stroke and offering an excellent safety profile.2-4 

THE PIONEER 
IN PFO CLOSURE1

The Amplatzer™ Talisman™ PFO Occluder set the standard as the first device supported by positive PFO trial results, developed specifically for patent foramen ovale (PFO) closure to reduce the risk of recurrent ischemic stroke.2 Our clinical evidence is unmatched, thanks to the largest-ever trial for PFO closure, boasting 5,810 patient-years of data.2

Today, with over 250,000 patients treated worldwide and a legacy spanning over 25 years, it is the #1 device worldwide.1

New data on Patients >60 years old

The device you know, just got better.

Built on the proven Amplatzer PFO closure technology with key enhancements:

  • New 30mm device for the complete PFO portfolio for every case
  • Device now pre-loaded onto the Amplatzer Talisman delivery cable, simplifying preparation and enhancing ease-of-use

The PFO Occluder trusted by thousands of physicians around the world1

250K+

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, 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 RCTS2,4-8


We demonstrate excellence

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

PFO closure reduces the risk of another stroke in patients 18-60 by 59% vs. medical management alone.9

In a real-world analysis of patients >60 years with presumed PFO-associated stroke, patients who received the Amplatzer Talisman PFO Occluder saw a 38% relative risk reduction of recurrent ischemic stroke over non-closure patients.10

Watch the webinar on new PFO >60 years data

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 peace of mind.

For more patient and caregiver resources and to learn more, head to www.PFOStroke.com

Christine, Amplatzer PFO patient.

*This testimonial relates an account of an individual’s response to the treatment. This patient’s account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient

Christine Lee, USA.

Nearly six months after Christine's stroke at age 33, her neurologist referred her to an interventional cardiologist and she was recommended to have a PFO closure.

"This little device has been completely life-changing for me."

WATCH THE VIDEO

KEY FEATURES

Often Imitated,
Never Matched1,11

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


*Only the 18 mm size is not asymmetric.

Minimizing Complexity in PFO Closure

SIMPLIFIED
PREP

Occluder comes assembled to Talisman™  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

Physician education

Hear the latest on real world outcomes with the Amplatzer Talisman PFO Occluder in patients >60 years

VIEW All Webinars

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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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 v7.0 | Item approved for U.S. use only.

References
  1. Data on file at Abbott.
  2. Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL. 2017. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med, 377(11), 1022-1032
  3. Sondergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjostrand C, Roine RO, Hildick-Smith D, Spence JD, Thomassen L. 2017. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med, 377(11), 1033-1042
  4. Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Bejot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guerin P, Piot C, Rossi R, Dubois-Rande JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Peirard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G. 2017. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med, 377(11), 1011-1021
  5. Tobis JM, Charles A, Silberstein SD, Sorensen S, Maini B, Horwitz PA, Gurley JC. 2017. Percutaneous closure of patent foramen ovale in patients with migraine: The PREMIUM trial. J Am Coll Cardiol, 70(22), 2766-2774
  6. Meier B, Kalesan B, Mattle HP, Khattab AA, Hildick-Smith D, Dudek D, Andersen G, Ibrahim R, Schuler G, Walton AS, Wahl A, Windecker S, Juni S. 2013. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med, 368(12), 1083-1091
  7. Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. 2018. Cryptogenic stroke and high-risk patent foramen ovale: The DEFENSE-PFO trial. J Am Coll Cardiol, 71(20), 2335-2342
  8. Mattle HP, Evers S, Hildick-Smith D, Becker WJ, Baumgartner H, Chataway J, Gawel M, Gobel H, Heinze A, Horlick E, Malik I, Ray S, Zermansky A, Findling O, Windecker S, Meier B. 2016. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Heart J, 37(26), 2029-2036
  9. Kent DM, Saver JL, Kasner SE. 2021. Heterogeneity of treatment effects in an analysis of pooled individual patient data from randomized trials of device closure of patent foramen ovale after stroke. JAMA 326(22), 2277-2286
  10. Saver JL et al. 2024. Device closure of patent foramen ovale in patients >60 years with ischemic stroke: Results from US Medicare beneficiaries ESOC
  11. Stähli BE, Nietlispach F, Meier, B. (2020). Chapter 14 - Percutaneous PFO Closure: History, Devices, Techniques, Safety, and Informed Consent. In M Khalid Mojadidi, B Meier, JM Tobis (Ed.). Patent Foramen Ovale Closure for Stroke, Myocardial Infarction, Peripheral Embolism, Migraine, and Hypoxemia (pp. 171-184). Academic Press
  12. Chemical Characterization Testing Data on File.
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.

  • Rx Only

    AMULET™ STEERABLE DELIVERY SHEATH

    INDICATION FOR USE

    The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.

    CONTRAINDICATIONS

    The Amulet™ Steerable Delivery Sheath is contraindicated for patients:

    • With the presence of thrombus that is in the pathway of the steerable sheath, including within the left atrial appendage
    • With active infections including endocarditis

    The Amulet™ Steerable Delivery Sheath is contraindicated for use with a power injection system.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events that can occur during or after a procedure using this sheath may include but are not limited to: Air embolism, Allergic reaction/toxic effects (due to anesthesia, contrast media, etc.); Arrhythmia; Arteriovenous fistulae; Bleeding; Cardiac tamponade; Cardiac perforation; Death; Dissection; Embolism; Foreign material embolus; Heart failure; Hematoma; Hypotension/hypertension; Infection; Myocardial infarction/ischemia; Pericardial effusion; Peripheral embolism; Pseudoaneurysm; Stroke; Thrombosis; Transient ischemic attack; Vascular access site injury (such as arteriovenous fistulae, hematoma, pseudoaneurysm), Vessel trauma/damage.

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