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The RESPECT Trial

Clinical evidence i Stock 544966382

The leading device, the landmark trial, and a turning point for PFO closure

The Amplatzer™ Talisman™ PFO Occluder is built off the most studied device that demonstrated excellent safety and efficacy in reducing the risk of recurrent stroke.

The landmark RESPECT Trial¹

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Most patients studied

The RESPECT trial remains the largest randomized controlled trial on PFO closure.

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Most extensive follow-up

The trial spanned 13 years, collecting 5,810 patient-years of data.

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Patient benefits¹

The Amplatzer PFO Occluder significantly lowers the risk of recurrent ischemic stroke, as compared to medical therapy alone.

A rigorous design, demonstrating significant stroke reduction

The results of the landmark RESPECT trial—a rigorous trial evaluating PFO occlusion—were published in the September 14, 2017 issue of the New England Journal of Medicine.

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Rigorous PFO trial

Broad inclusion criteria, with extensive follow-up

The landmark RESPECT trial is the largest trial with the most extensive patient follow-up of any trial conducted on PFO closure to reduce the risk of recurrent ischemic stroke.

  • The trial enrolled 980 patients at 69 medical centers across the U.S. and Canada
  • One group underwent PFO closure plus antithrombotic medication (almost exclusively antiplatelet); the other group received antithrombotic medication only (antiplatelets or anticoagulants)
  • Patients on anticoagulation therapy were not excluded from the trial
  • Patients in the trial were followed for a median of 5.9 years
  • The trial collected a total of 5,810 patient-years of data, more follow-up than any other PFO trial

Highlights from the RESPECT trial

No device erosion, device embolization, or device thrombus

0%
Data from the closure group of the RESPECT trial showed low rates of Serious Adverse Events (SAEs), including no incidence of device erosion, device embolization, or device thrombus and low risk of serious atrial fibrillation, consistent with medical therapy.¹

Efficacy: significantly reduced risk of recurrent stroke¹

45%
The RESPECT trial also demonstrated a 45% relative risk reduction for any recurrent ischemic stroke with the use of the Amplatzer PFO Occluder.1,*
62%
The RESPECT trial showed that there was a 62% relative risk reduction for recurrent cryptogenic stroke with the use of the Amplatzer PFO Occluder.1,*

*As compared to medical therapy alone.

Consistency: Excellent procedural results¹

94.2%
94.2% effective PFO closure
(n≤9 bubbles at 6 months).
99.1%
The Amplatzer PFO Occluder demonstrated 99.1% technical success.²˒*
96.1%
The Amplatzer PFO Occluder demonstrated 96.1% procedural success.²˒†

Learn more about the PFO Closure Procedure with the Amplatzer™ Talisman™ PFO Occluder

Read about the procedure
References

*Technical success = Successful delivery and release of the device.
†Procedural success = Successful implant of the device with no in-hospital serious adverse events.

  1. 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. doi: 10.1056/NEJMoa1610057
  2. Carroll JD, Saver JL, Thaler DE, et al. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013;368:1092-100. doi: 10.1056/NEJMoa1301440
MAT-2002579 v3.0 | Item approved for U.S. use only.

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