GORE® CARDIOFORM Septal Occluder for PFO Closure
Gore REDUCE Clinical Study five-year results demonstrate PFO closure provides safe long-term prevention of recurrent stroke.
The REDUCE Study is the only U.S. IDE trial that achieved its primary end point and showed the largest reduction in recurrent ischemic stroke*,1 in all PFO shunt sizes over medical therapy alone.
Clear data. Confident stroke prevention.
ROBUST TRIAL DESIGN
EFFICACY
Groundbreaking 77% relative reduction in recurrent stroke for cryptogenic stroke patients*,1
Rapid demonstration of statistically significant stroke reduction:
Met primary endpoint in the intention-to-treat analysis*,1 with an average follow-up of 3.4 years
Met primary end point in ALL PFO anatomies and ALL shunt sizes*,1
Number needed to treat: Only 28 patients treated to prevent one stroke at 24 months1
The REDUCE Study was the first U.S. Investigational Device Exemption (IDE) study of a PFO closure device to show a statistically significant reduction in stroke recurrence in the primary intent-to-treat analysis.
— Scott Kasner, MD, Neurologist, Perelman School of Medicine at University of Pennsylvania
CONTINUED LEGACY OF SAFETY
CLOSURE PERFORMANCE
SEE THE NEW ENGLAND JOURNAL OF MEDICINE ARTICLE
Important Information
This information is intended for education and awareness only. Patients should consult their physician for information on the risks associated with the devices and surgical procedures discussed in this website. All surgical procedures carry potential health risks. Not all patients will be candidates for treatment with these devices, and individual outcomes may vary.
Always follow physician advice on your post-surgery care and recovery.
Refer to the Instructions for Use for a complete list of warnings, precautions, contraindications, potential adverse events, and patient-specific information.
Caution: U.S. law restricts use of this device on the order of a physician (Rx).
References
* The REDUCE study determined safety and efficacy of patent foramen ovale (PFO) closure with the GORE® CARDIOFORM Septal Occluder or GORE® HELEX® Septal Occluder plus antiplatelet medical management compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke. All PFO anatomies were incorporated into this study within indicated sizing parameters of the Instructions for Use.
** Cryptogenic diagnosed as: No stenosis > 50 percent or ulcerated plaque in relevant intra- or extra-cranial vessels, no atrial fibrillation or high-risk source of cardioembolism, non-lacunar (based on neuroimaging), no evidence of hypercoagulable disorder, no other known cause of stroke.
† PFO confirmed by transesophageal echocardiography (TEE / TOE) with bubble study demonstrating right-to-left shunt at rest or during Valsalva maneuver. Patients with PFO eligible regardless of shunt size or presence of atrial septal aneurysm.
‡ There was no statistically significant difference in the rate of serious adverse events (SAE) between the closure and medical groups. There was a significantly higher rate of atrial fibrillation or flutter in the closure group (6.6 percent versus 0.4 percent) but the majority was non-serious (66 percent), peri-procedural (69 percent had onset within 30 days of the closure procedure), and had rapid resolution (59 percent with resolution within two weeks of onset). Average of 3.4 years follow-up.
§ Device and procedure-related SAEs occurred in 1.4 and 2.5 percent, respectively, of closure patients.
II GORE® CARDIOFORM Septal Occluder effective closure rate results in device group subjects who received a study device. Effective closure defined as freedom from large shunt > 25 bubbles as detected by transthoracic echocardiography adjudicated by echo core lab.
1.) Søndergaard L, Kasner SE, Rhodes JF, et al; Gore REDUCE Study Investigators. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. New England Journal of Medicine 2017;377(11):1033-1042.