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Study examines novel PFO closure system
May 11, 2009A new device designed to close a common heart defect known as a patent foramen ovale (PFO) is safe and effective at 90-days follow up, according to a new study released today at the Society for Cardiovascular Angiography and Interventions (SCAI) 32nd Annual Scientific Sessions in Las Vegas.
PFO is a common condition in which a hole that connects the two upper chambers of the heart (atria) during fetal development fails to close properly after birth. About 25 percent of the general population has PFO, which is associated with an increased risk of stroke. PFO may also be associated with migraines and decompression illness in divers.
The FlatStent EF, developed by Coherex Medical,Inc., is unique because it is implanted within the PFO tunnel, leaving a minimal amount of the device exposed to circulation, which could reduce the risk of blood clots. The mechanism of action of the FlatStent EF should limit the incidence of other major complications associated with septal patching devices currently in use, such as erosion, persistent arrhythmia, and valve apparatus distortion.
In the study, 29 of 41 patients (70.7%) who received the FlatStent EF™ PFO Closure System had complete PFO closure immediately following implantation. After 90 days, 17 of 19 patients (89%) had complete or clinical closure. The remaining 22 patients had not yet completed the 90-day follow up exam.
"The FlatStent is designed to be safer and easier to use than current PFO closure systems," said Horst Sievert, MD, professor of internal medicine, cardiology and vascular medicine at the Cardiovascular Center in Frankfurt, Germany, and the study's principal investigator. "Given the number of patients living with PFO, the results of this study show promise in providing additional treatment options that could help prevent stroke and other conditions associated with PFO."
In the study, no device-related complications were reported. The 100-patient, multicenter registry study is designed to evaluate 30, 90 and 180-day safety and performance.
Society for Cardiovascular Angiography and Interventions
In the study, 29 of 41 patients (70.7%) who received the FlatStent EF™ PFO Closure System had complete PFO closure immediately following implantation. After 90 days, 17 of 19 patients (89%) had complete or clinical closure. The remaining 22 patients had not yet completed the 90-day follow up exam.
"The FlatStent is designed to be safer and easier to use than current PFO closure systems," said Horst Sievert, MD, professor of internal medicine, cardiology and vascular medicine at the Cardiovascular Center in Frankfurt, Germany, and the study's principal investigator. "Given the number of patients living with PFO, the results of this study show promise in providing additional treatment options that could help prevent stroke and other conditions associated with PFO."
In the study, no device-related complications were reported. The 100-patient, multicenter registry study is designed to evaluate 30, 90 and 180-day safety and performance.
Society for Cardiovascular Angiography and Interventions
Cardiovascular Angiography Current Events and Cardiovascular Angiography News RSSStudy finds African Americans at greater risk after PCI
A study from one of the largest public health systems in the country has found that African American patients experienced significantly worse outcomes after angioplasty and stenting than patients of other races, though researchers are not sure why.
Study shows benefits of anti-clotting medications reduced by common heartburn drugs
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Studies may show how to close the gap between women and men who suffer heart attacks
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SYNTAX defines borders between CABG and PCI with TAXUS drug-eluting stents
Coronary artery bypass grafting (CABG) should remain the "standard of care" for patients with complex coronary artery disease, concludes the SYNTAX study, published in the New England Journal of Medicine (online February 18, 2009, Print edition March 5).
New appropriate use criteria guide treatment of patients with heart blockage
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SAPPHIRE trial shows long-term benefit of carotid stenting as alternative to surgery
Carotid artery stenting is an effective option for high risk patients who are not eligible for surgery, according to a long-term study published in this week's New England Journal of Medicine. Carotid artery disease, which involves clogging of the arteries in the neck that provide blood to the brain, is a significant risk factor for stroke, making these study results important for the estimated 200,000 Americans each year who would otherwise not be candidates for the treatment.
Broad-based group of physicians calls for improvement in stroke treatment
A coalition of physicians representing a wide range of medical specialties has issued a call to action to improve the treatment of stroke.
SCAI highlights study using wireless technology to speed care of heart attack patients
Imagine paramedics mobilizing a team of cardiologists and nurses within minutes of arriving at the home of a person who is having a heart attack, simply by pressing a button that sends an electrocardiogram (ECG) over a wireless network.
Long-term anti-clotting therapy sweetens stenting outcomes in diabetic patients
A study showing that diabetic patients who are treated with long-term anti-clotting therapy are less likely to have a heart attack or die more than a year after stenting has been named among the best research papers presented at the 30th Annual Scientific Sessions of the Society for Cardiovascular Angiography and Interventions (SCAI), May 9-12, 2007.
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