Setting the standard around the world
- Over 130,000 patients treated worldwide¹
- Pioneered the treatment with a PFO-specific device
Helping Patients Live Healthy Lives Through Significant Stroke Reduction
Clinical studies confirm superiority
Three extensive clinical studies confirm the superiority of PFO closure to medical management in reducing the risk of stroke recurrence.
| Respectᵃ | Reduceᵇ | Closeᶜ | |
|---|---|---|---|
| Devices used | 100% Amplatzer™ PFO Occluder | 39% Gore® Helex® 61% Gore® Cardioform | 51% Amplatzer™ PFO Occluder; 49% approved PFO devices |
| Patients | 980 | 664 | 473 |
| Follow-up patient years |
5,810 (median 5.9 yrs) |
2,232 (median 3.2 yrs) |
Not reported (median 5.4 yrs) |
| Anticoaulant allowed in control group? Relative risk reduction |
Yes 62% (Recurrent ischemic stroke unknown mechanism) |
No
77% (Recurrent ischemic stoke) |
Noᵈ
97% (Recurrent ischemic stroke) |
| Effective closure |
94.2% Freedom from > 9 bubbles (Evaluated after 6 months) |
94.5% Freedom from 25 bubbles (Evaluated after 12 months) | Not reported |
Find out why the Amplatzer ™ PFO Occluder is relied upon by thousands of physicians around the world.
Raising the bar with the landmark RESPECT Trial²
- 5,810 patient-years of data
- Most extensive patient follow-up, >2X more than other PFO trials
Demonstrating excellence 990 patients implanted with device in RCTS*
- ZERO device erosions, device thrombus or embolization events in SIX** published trials with 990 patients²⁻⁷
- 94.2% effective closure rates at 6 months²
Learn more about the RESPECT Trial
Discover more about the largest trial with the most extensive patient follow-up of any trial conducted on PFO closure and its impact on the prevention of recurrent ischemic strokes.
The RESPECT Trial*RCTs=Randomized Clinical Trials
**Patients in device group of each trial implanted with Amplatzer™ PFO occluder device: RESPECT = 465, PREMIUM = 119, PC = 191, CLOSE = 121, DEFENSE = 53, PRIMA = 41.
- Internal data. Data on-file at Abbott.
- 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: 1022-32.
- Tobis J, Charles A, Silbertson D, et al. Prospective, randomized investigation to evaluate incidence of headache reduction in subjects with frequent migraine and PFO using the AMPLATZER PFO occluder to medical management. J Am Coll Cardiol 2017; 70:2766-74.
- Meier B, Kalesan B, Mattle HP, et al. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med 2013; 368: 1083 - 91.
- Mas J-L, Derumeaux G, Guillon
B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med 2017;377:1011-21 and supplementary appendix. - Lee PH, Song J-K, Kim JS, et al. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial, Journal of the American College of Cardiology (2018), doi: 10.1016/j.jacc.2018.02.046.
- Heinrich P. Mattle, Stefan Evers, David Hildick-Smith, et al. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial, European Heart Journal, Volume 37, Issue 26, 7 July 2016, Pages 2029–2036.
a. 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: 1022-32.
b. Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017; 377: 1033-42.
c. 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: 1011-21.
d. This table focuses on PFO occluder group vs. antiplatelet only group.- Internal data. Data on-file at Abbott.