Doctors treating patients with a congenital heart defect have found an
unexpected side effect of their work — repairing the heart condition
apparently relieves migraines. Now, a company that developed a device
to fix the heart defect is seeking approval to use it specifically as a
migraine treatment.

Cierra, of Redwood City,
California, manufactures the PFX Closure System, a device that uses
energy to close the heart defect known as a patent foramen ovale, or
PFO — an opening in the heart.

Doctors thread the device through a vein in the groin and snake it
up the torso until it enters the upper right chamber of the heart.
There, the device lands on the PFO, applies suction to hold it closed,
and directs radio-frequency energy at the closure site, essentially
"welding" the tissue together.

The device is in the midst of clinical trials in Europe, and Cierra
president and CEO Erik Engelson expects it to be approved as a PFO
treatment in Europe by mid-2006. The company also plans to launch a
clinical trial of the device in migraine patients in the United States
next year.

"This will be a pivotal trial for the migraine indication," Engelson
says. "We’re looking at a pharmaceutical-sized market for a medical
device." If approved for use in the United States, he predicts, the
treatment could be an industry in the range of $2 billion.

Cierra’s system is the first to close PFOs without leaving behind a
device implanted in heart tissue, and this was a key factor in
developing a treatment specifically for the migraine condition,
Engelson says.

"Migraine patients tend to be otherwise healthy and young," he says.
"Implanting something permanent in these individuals didn’t seem to be
the appropriate level of risk, whereas leaving nothing behind seemed to
be a better approach."

By Jenny Cutraro

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