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 The device is woven from a nickel-titanium alloy that can be
collapsed and delivered within a catheter to the heart, where it’s
then expanded to repair a hole. Traditional Aymara weavers repeat an
Andean cross or chakana symbol up to 120 times to craft the device,
called Nit-Occlud ASD-R.
“To my knowledge, it is the first time metal weaving is used for
medical devices in Bolivia,” said lead study author Dr. Alexandra
Heath of Kardiozentrum in La Paz, Bolivia in email to Reuters
Health.
“It is surprising, that these women, after a training, can assume
the task brilliantly,” said Heath, who has received consulting fees
from the device manufacturer PFM Medical.
Heart defects are more common at high altitudes, possibly because of
the effects of low oxygen, Heath and colleagues write. In La Paz, at
an altitude of 12,000 feet (4,000 meters), cardiologists often
encounter kids with defects that involve holes in the heart.
Many commercially available devices can be used to patch these
holes, and open heart surgery is also an option. Developers sought
to create an alternative device using local craftswomen in part
because open heart surgery is an option in Bolivia only for the most
extreme cases.
Commercial devices to repair holes in the heart are made from woven
mesh discs that expand to fill the defective area. Developers of the
hand-woven device thought they might be able to train local weavers
to craft something similar.
Engineers teamed with weavers to identify the best pattern and
materials for the device.
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Now, a team of about 40 craftswomen who went through four months of
training weave devices that meet specific requirements for quality
control, sterilization and proper chemical treatment.
The Nit-Occlud ASD-R has been approved to repair heart defects in
adults and children by regulators in Canada, Europe, and South
America. It is not approved in the U.S.
This hand-crafted device essentially copies existing devices which
are made in developed countries by “weaving” machines, said Dr. John
Moore, director of cardiology at Rady Children’s Hospital in San
Diego, California. Moore is involved in a study of a device by PFM
Medical and has been compensated for work with two other device
companies, 480 Biomedical Corporation and Transmural Systems.
“In Bolivia, where the art of hand weaving is widespread and very
developed and the economy is underdeveloped, it may be
cost-effective to produce such devices by hand,” Moore said by
email.
“This is certainly not the case in developed countries,” Moore
added. “Similar machine made devices have been FDA approved for more
than 15 years and are used widely in the developed and for that
matter in the developing world.”
SOURCE: http://bit.ly/2FxK3P3 JAMA, online March 13, 2018.
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