Amplatzer™ Talisman™ PFO Occluder
>180K Implants Globally1 | 5,810 Patient-Years of Data2
PFO-Associated Stroke3-5
It is estimated that around a quarter of ischaemic strokes are of an unknown cause.
Around half of patients with an ischaemic stroke of unknown cause had a PFO.
~59% relative risk reduction of recurrent stroke with PFO-closure vs medical therapies.
Most people with a PFO are asymptomatic. But an atrial septal aneurysm may open the PFO with every heartbeat, thereby increasing the possibility for thrombus to pass from the venous to the arterial system, which can cause a stroke.4
Is there an option for those who have had a PFO-associated stroke?
For patients who have experienced a PFO-associated stroke, clinical trials have shown that they can benefit from PFO closure.2,6,7
*The testimonial does not provide any indication, guide, warranty or guarantee as to the response patients may have to the treatment or effectiveness of the product or therapy in discussion. Opinions about the treatment discussed can and do vary and are specific to the individual's experience and might not be representative of others.
References
1. Data on file at Abbott.
2. Saver JL, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-1032.
3. Saver, J.L. Cryptogenic Stroke. NEJM. 2016;374:2065-74.
4. Mojadidi MK, et al. Cryptogenic stroke and patent foramen ovale. J Am Coll Cardiol. 2018;71(9):1035-1043.
5. Messé SR, et al. Practice advisory update summary: Patent foramen ovale and secondary stroke prevention. Neurology®. 2020;94:1-10.
6. Mas J-L, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017; 377: 1011-21.
7. Søndergaard L, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377:1033-1042.
Why choose the Amplatzer™ Talisman™ PFO Occluder?1,2
The Amplatzer™ Talisman™ PFO Occluder is a minimally-invasive option to reduce the risk of recurrent ischaemic stroke in patients with a PFO.2
The PFO Occluder trusted by thousands of physicians around the world1
Our clinical evidence is unmatched, thanks to the largest-ever trial for PFO closure, boasting 5,810 patient-years of data2
Pioneered treatment with a PFO-specific device that is available in >80 countries around the world
About the Amplatzer™ Talisman™ PFO Occluder
The Amplatzer™ Talisman™ PFO Occluder Features1,2
Over 20 years ago, we pioneered PFO closure with the Amplatzer™ PFO Occluder. Today, it is the most-studied device of its kind, with over 180,000 patients treated worldwide.1 Our clinical evidence is also unmatched, thanks to the largest-ever trial for PFO closure, boasting5,8 10 patient-years of data.2
With the introduction of the Amplatzer™ Talisman™ PFO Occluder, we have built upon the proven Amplatzer PFO closure technology:
- The occluder now comes assembled and ready to use, simplifying prep and enhancing ease-of-use.
- We have also refined the 30mm size to have a smaller left atrial disc, which has been designed to help avoid interference with surrounding structures.
The easy-to-use device just got easier.
Minimising Complexity in PFO Closure
Self-Expanding Discs
Linked by a short-connecting waist, the discs align to the PFO with no need for an additional “locking” step
Recapturable & Repositional
Ensure optimal anatomical placement of the device for effective closure
Low-Profile Delivery
8 F and 9 F introducer sheaths enable treatment of patients with smaller vasculature
References
1. Data on file at Abbott.
2. Saver JL, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-1032.
Why have >180k people chosen the Amplatzer™ PFO Occluder & the Amplatzer™ Talisman™ PFO Occluder?2-6
ZERO device erosions, thrombus, or embolisation events in 6 published trials with 990 patients2-6
Discover Evidence from the RESPECT Trial2
The RESPECT trial is the largest trial ever conducted on PFO closure, with extensive patient follow-up spanning 13 years. This trial studied the Amplatzer™ PFO Occluder.
- 980 enrolled patients were followed for a median of 5.9 years.
- 5,810 patient-years of data—almost 2 times more than other PFO trials.
- Conducted at 69 centres across the U.S. and Canada and included patients on anticoagulation therapy – a real-world cross-section of patients – unlike other PFO trials, REDUCE and CLOSE.
The Findings2
The RESPECT trial offers conclusive evidence that using the Amplatzer™ PFO Occluder to close the PFO in patients with a PFO-associated stroke is more beneficial than medical therapy alone, reducing the risk of another stroke.
94.2% effective closure rates at 6 months2
Three trials compared PFO closure to medical management in reducing risk of recurrent stroke2-4
| Respect2 | Reduce3 | Close4 | |
|---|---|---|---|
| Devices Used | 100% AMPLATZERTM PFO Occluder | 39% GORE‡ HELEX, 61% GORE Cardioform | 51% AMPLATZER PFO Occluder, 49% Other Approved PFO Devices |
| Patients | 980 | 664 | 473 |
| Follow-up-Patient Years | 5,810 (median 5.9 yrs) | 2,232 (median 3.2 yrs) | NR* (mean 5.4 yrs) |
| Anticoagulant Allowed in Control Group? | Yes | No | No |
| ↓ | ↓ | ↓ | |
| Relative Risk Reduction | 62% (Recurrent Ischaemic Stroke of Unknown Mechanism) | 77% (Recurrent Ischaemic Stroke) | 97% (Recurrent Ischaemic Stroke) |
| Effective Closure | 94.2% Freedom From >9 Bubbles (Evaluated After 6 Months) | 94.5% Freedom From >25 Bubbles (Evaluated After 12 Months) | NR* |
*Not Reported
‡ Indicates a third party trademark, which is property of its respective owner.
References
1. Data on file at Abbott.
2. Saver JL, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-1032.
3. Søndergaard L, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017;377:1033-1042.
4. Mas J-L, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med 2017;377:1011-21 and supplementary appendix.
5. Lee PH , et al. (n.d.). Cryptogenic stroke and high-risk patent foramen ovale: The defense-PFO trial. - PubMed - NCBI.
6. Mattle HP, et al. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial, European Heart Journal. 2016;37(26):2029 -2036.
Referral
Australian Clinical Guidelines3
In 2019, the Australian Clinical Guidelines for Stroke Management 2017 were updated to strongly recommend for PFO closure in ischaemic stroke patients aged <60 in whom a patent foramen ovale is considered the likely cause of stroke after thorough exclusion of other aetiologies (causes).
Treatment Planning
In considering your treatment options, the safety and effectiveness of device closure compared to antithrombotic therapy alone should be taken into account. A shared decision-making process between the patient and medical team is recommended.
Multiple Considerations During Treatment Planning4
Procedure
How to Implant the AmplatzerTM PFO Occluder
References
1. Data on file at Abbott.
2. Saver JL, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017;377:1022-1032.
3. Stroke Foundation. Clinical Guidelines for Stroke Management. Available at https://informme.org.au/en/Guidelines/Clinical-Guidelines-for-StrokeManagement. Accessed April 2022.
4. Kernan et al. AHA/ASA Guidelines for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack. Stroke. 2014;45(7):2160-2236.
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