BEGIN YOUR JOURNEY TOWARDS PREVENTING CRYPTOGENIC STROKE

If you’ve had a stroke due to an unknown cause, learn how you may be able to prevent another with the Amplatzer™ PFO Occluder.

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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™ PFO Occluder, the leading PFO closure device, demonstrated excellent safety and efficacy in reducing the risk of recurrent stroke in the largest PFO trial ever conducted.

The landmark RESPECT Trial¹

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Most patients studied

The RESPECT trial is the largest clinical trial evaluating patent foramen ovale (PFO) closure.

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Most extensive follow-up

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

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Patient benefits¹

The Amplatzer™ PFO Occluder significantly lowers the risk of recurrent ischemic stroke.

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 and the prevention of recurrent ischemic stroke.

  • The trial enrolled 980 patients at 69 medical centers across the U.S. and Canada
  • 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

Safety: No device embolization, aortic erosion/dissection, device thrombus

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

Efficacy: significantly reduced risk of recurrent stroke¹

45%
The trial also demonstrated a 45% relative risk reduction for any recurrent ischemic stroke over nearly six years of follow-up with the use of the Amplatzer™ PFO Occluder¹
62%
The RESPECT trial showed that there was a 62% relative risk reduction for recurrent cryptogenic stroke with the use of the Amplatzer™ PFO Occluder¹

Consistency: Excellent procedural results¹

94.2%
94.2% effective PFO closure (n≤9 bubbles at 6 months). Patients measured after only 6 months demonstrated freedom from shunt at both rest and Valsalva.
99.1%
In the RESPECT Trial, the Amplatzer™ PFO Occluder demonstrated 99.1% technical success.²*
96.1%
In the RESPECT Trial, the Amplatzer™ PFO Occluder demonstrated 96.1% procedural success with excellent effective closure.²**

Find out more about the Amplatzer™ PFO Occluder and the PFO closure procedure.

Learn more about the Amplatzer™ PFO Occluder Read about the PFO closure procedure
Reference

* 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.
  2. Carroll et al (2013). Closure of Patent Foramen Ovale versus Medical Therapy after Cryptogenic Stroke. N Engl J Med 368;12 nejm.1092 org
MAT-2002579 v2.0 | Item approved for U.S. use only.