PFO Closure: Where Do We Stand?
Article preview reprinted Medtech Insight - May, 2009
The PFO (patent foramen ovale) closure market has certainly traveled a long and twisted road over the years. And the journey isn't over yet. Although some large companies have pulled back on their US commercialization efforts or decided to exit the field entirely, othrs continue to stick it out, hoping the eventual opportunity will far outweigh the risks and costs involved. In Europe, where percutaneous PFO closure following stroke/TIA is more widely accepted and performed, there are nine CE marked PFO closure devices available from eight different manufacturers, with two more devices expected to be added to the mix in the near future. But despite widespread European acceptance, manufacturers have so far failed to achieve the ultimate goal: US regulatory approval. Find out more...
PFO Closure: Where Do We Stand?
Article preview reprinted Medtech Insight - May, 2009
The PFO (patent foramen ovale) closure market has certainly traveled a long and twisted road over the years. And the journey isn't over yet. Although some large companies have pulled back on their US commercialization efforts or decided to exit the field entirely—Cordis Corp./Johnson & Johnson, for example, announced last year that it was shelving work on its SeptRx PFO device—others continue to stick it out, hoping the eventual opportunity will far outweigh the risks and costs involved.
PFO is a congenital cardiac defect that occurs when a flap-like opening in the septal wall between the right and left atrial heart chambers fails to fully close after birth. The defect is believed to be present, to some degree, in up to 25% of the population, but as symptoms are often nonexistent, it is rarely detected until something more serious goes wrong. PFOs vary in severity, but may occasionally allow unfiltered blood to bypass the lungs and enter the arterial circulation. This increases the risk that embolic materials will travel to the brain and adversely impact blood flow. Although the link between PFO and serious conditions, such as transient ischemic attack (TIA) and stroke, is still not definitive, many believe PFOs (and large defects, in particular) may increase the risk of stroke and could also trigger other adverse brain events, such as migraine episodes.
The association between stroke and TIA in patients with PFO has been known for 20 years, but no preventive treatment was readily available until percutaneous PFO closure methods came into play several years ago, first as off-label uses for existing atrial-septal defect (ASD) closure devices, and then later with dedicated PFO products. Although some neurologists remain skeptical about the benefit of PFO closure on stroke rates, pending the release of randomized trial data, there is some data to suggest that PFO closure does reduce stroke risk. This includes retrospective analyses of PFO closure compared to medical therapy that have demonstrated statistically significant freedom from recurrent stroke.
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Companies mentioned in this article:
AGA Medical Holdings Inc.
Case Western Reserve University
Rush University Medical Center
University of California, Los Angeles
University of California, San Francisco
Medtech Insight delivers the quality content you need on medical technologies impacting the spectrum of surgical, orthopedic, cardiovascular, and other markets. Written and edited by seasoned industry participants and experts, the Medtech Insight newsletter provides insights into the technology and market developments (devices, instrumentation, biomaterials, gene therapy, tissue engineering, etc.) impacting a wide range of surgical and non-surgical clinical practices (cardiothoracic & vascular surgery, general surgery, orthopedics & spine surgery, interventional radiology/cardiology, etc.). Learn more at www.medtechinsight.com.
