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Participating in the HELEXTM Septal Occluder
clinical trial
The HELEX Septal Occluder is a device used to close atrial septal defects
through a special catheterization procedure. The HELEX Septal Occluder is
currently available only through a clinical research study. This means that the
device is not yet commercially available for general widespread use by doctors
in the United States. The clinical trial is being conducted as part of a process
to gain Food and Drug Administration approval to be marketed in the United
States.
The purpose of the research study is to evaluate the safety and effectiveness
of the HELEX Septal Occluder. The HELEX Septal Occluder has some features that
make its design attractive for certain patients. It is softer and more flexible
than other devices and it is made of materials that modern surgeons prefer if
they need to patch a hole in the heart. It is not applicable to all ASDs,
however, so you will need to discuss if you or your child may be a candidate for
use of this device.
Additional
information
Sponsor of the clinical trial/manufacturer of the HELEX Septal Occluder
W.L. Gore & Associates, Inc.
Flagstaff, AZ 86004
www.goremedical.com
Investigators involved in the HELEX Septal Occluder at the Cleveland Clinic
Larry Latson, MD 216/445-6532
Lourdes Prieto, MD 216/445-3865
Contact information
If you or your child have an atrial septal defect and you would like more
information regarding this trial, please contact:
Kim Brown, RN, BSN
216/444-5380
800/223-2273 ext. 45380
brownk@ccf.org
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