THE ADVANCED SOLUTION FOR STROKE TEAMS AND THEIR PATIENTS.

FDA approved for PFO* closure and product image

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PROGRESSIVE DESIGN FOR PFO CLOSURE

 

Made from Gore proprietary, thromboresistant ePTFE** material, the GORE® CARDIOFORM Septal Occluder is designed with two independent discs that span and cover the anatomy of PFOs.

Conforms for confident closure with rapid tissue ingrowth: 98% effective closure rate†, 1

Optimal apposition: Low profile design conforms to the surrounding anatomy and allows for rapid endothelialization

Minimal wall injury: An ePTFE-covered nitinol frame performs in harmony with the heart to avoid tissue damage

WATCH how the GORE CARDIOFORM Septal Occluder is implanted

WATCH how the GORE® CARDIOFORM Septal Occluder is implanted.

** ePTFE – expanded polytetrafluoroethylene

Learn More

The groundbreaking results of the Gore REDUCE Study changed the neurology community’s perspective on PFO closure. [T]hese data prove the value of closing PFOs to prevent recurrent ischemic stroke...

— Scott Kasner, MD, Neurologist, Perelman School of Medicine at University of Pennsylvania

The soft and conformable design of Gore’s device is ideal for providing long-term repair of PFOs of any shunt size...

—  John Rhodes, MD, Medical University of South Carolina

The FDA approval of the GORE® CARDIOFORM Septal Occluder for PFO closure marks a significant milestone in the long journey to confirm the heart-brain relationship connecting PFO and stroke...

— John Rhodes, MD, Medical University of South Carolina

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

* Refer to Instructions For Use for complete indication

† 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.

Instructions for Use available here