THE LEADING DEVICE,
THE LANDMARK TRIAL
AND A TURNING POINT
FOR PFO CLOSURE.
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 TRIAL
THE RESPECT TRIAL IS THE LARGEST CLINICAL TRIAL OF PATENT FORAMEN OVALE (PFO) CLOSURE.
THE TRIAL SPANNED 13 YEARS, COLLECTING OVER 5,810 PATIENT-YEARS OF DATA.
AMPLATZER™ PFO OCCLUDER SIGNIFICANTLY LOWERS RISK OF RECURRENT ISCHEMIC STROKE AND OFFERS AN EXCELLENT SAFETY PROFILE.
A RIGOROUS DESIGN DEMONSTRATING SIGNIFICANT STROKE REDUCTION
The results of the landmark RESPECT trial—a rigorous trial of PFO occlusion—were published in the September 14, 2017 issue of the New England Journal of Medicine.
RIGOROUS PFO TRIAL
BROAD INCLUSION CRITERIA, MOST 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 its impact on the prevention of recurrent ischemic stroke.
- The trial enrolled 980 patients at 69 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
INVALUABLE PATIENT BENEFITS
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
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 OCCLUDER.1
REPRODUCIBLE: EXCELLENT PROCEDURAL RESULTS1
(n≤9 BUBBLES AT 6 MONTHS)
Patients measured after only 6 months demonstrated freedom from shunt at both rest and Valsalva.
In the RESPECT trial, the AMPLATZER™ PFO Occluder demonstrated 99.1% technical success and 96.1% procedural success, with excellent effective closure according to highly stringent criteria.
- 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.