Closure Device Helps Prevent Strokes

A new closure system for patent foramen ovale (PFO) has been shown in a clinical trial to be successful in 87% of cases, representing a way to prevent strokes associated with PFOs. The results were reported at the annual meeting of the Transcatheter Cardiovascular Therapeutics (TCT) symposium in Washington (DC, USA) in October 2005.

PFO is a small hole between the upper chambers of the heart that can allow unfiltered venous blood to enter the arterial circulation. If this unfiltered blood contains a clot or other debris, it can trigger a stroke or transient ischemic attack (TIA). Around 10% of strokes are associated with PFOs. Researchers have found that people with a closed PFO appear to have less recurrence of stroke. Everyone is born with a PFO but most close naturally during infancy. About 25% of adults have a PFO. PFOs are also associated with migraine headaches. An upcoming clinical trial will explore this relationship.

The Premere PFO closure device was developed by St. Jude Medical (St. Paul, MN, USA). The trial included 67 patients at five research centers in Europe. The device is implanted by a transcatheter, which is less invasive than open heart surgery. A doctor delivers the closure device through the PFO and then opens the two sides independently, allowing placement of the device and closure of the PFO.

"The Premere design conforms well to PFO anatomy, using materials that minimize complications, limit the body's exposure to foreign material, and enable physicians to precisely place the device,” observed Paul R. Buckman, president of St. Jude Medical's Cardiology Division. "The absence of complications during the trial confirms the device was successful in meeting these important clinical objectives.” Premere has received the CE Mark .




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