FDA Regulations on Medical Devices
Now
that it has been crunch time for Senior Design. My group’s bio-medical device
has stringent FDA regulations that need to be met to even be considered to be
used. After much research for our device
and similar devices in the past; I realized that their path to being approved is
sometimes quite absurd. It is understandable that “devices” such as band- aids
are Class I and less stringent because most likely they will not cause harm to
the person. But when you get into Class II and Class III devices that have direct
contact and a direct possibility of causing harm is where the FDA cracks down.
Now I believe that it is great that they crack down but in some circumstances
it is too extreme.
There
are bioabsorable stents which provide transient support to the vessel and
degrade over time. These are alternatives to the permanent bare-metal stent and
drug-eluting stents. The benefit of the absorbable stent is that you do not
have to have a new one put in after the previous one breaks down. That means
that the patient will only have to have one surgery instead of multiple, and
every surgery comes with its associated risks.
In
2011 the first drug-eluting bioabsorbable stent was approved for commercial use
in Europe. Abott Vascular received CE mark approval for the bioabsorbable
vascular scaffold. It was approved in Europe to treat coronary artery disease. At this time there was not much research
proven that the stents were beneficial and did not cause harm, so two years ago
I agree with the FDA for not allowing for commercialized use.
The
first fully biodegradable coronary stent was used in a patient in India. Barely
a week after the Drug Controller General of India approved the usage of
biodegradable coronary stent in India a local doctor performed the surgery.
Just a week after being approved the cardiologist had no qualms in providing
this implant to his patients. He said “the artery will behave like a natural
artery. Thrombosis is reduced by six months to a year. Another advantage of using this stent is that even if the patient
develops a new disease, surgery can be done on the artery which was risky
earlier," said Dr Chopda. The
Times of India reports that doctors have implanted more than 2,500 Absorb
stents since the device's launch in late September, spread across 250 centers
in 45 cities. It is clear that
the device has much more positive effects for the patients then continuing to
hold out
Absorb
that was first approved in 2011 is currently authorized for sale in more than
30 countries in Europe and parts of Asian Pacific and Latin America. This will
most likely to be the first stent approved in the United States but not for
another two to three years. It has proven to be safe and relief to heart
patients with severe blockages. The question is after two years of research and
statistics is there another factor they do not want the public to know about?
Recently
there has been research on the financial side of this device. By early 2019,
the sales are likely to be over USD 700 million. Despite not being FDA approved
in the US, they are expected to be the owner of the largest market share once approval
is received. At present, Abbott Vascular and Kyoto Medical Planning rein in the
global market but new companies (e.g. Biotronik) are likely to start
participating actively in the market activity. Now if this device has
such a large financial benefit, has been proven to work in Europe and other
countries what is the FDA waiting for. The scope of this device and the market
it has to reach could be a reason why the FDA is holding out. Financial
benefits do drive many decisions in the medical field since there is not
socialized medicine like in Europe. It
is just extremely interesting to me how the FDA works and how many devices get
approved while some do not. In this case maybe they are still waiting to find
out long term affects and if the patient will not react well. But there are
many people already benefiting from the hours and hours of research scientists
have put in to provide such a device to the world.
Sources:
http://online.wsj.com/article/PR-CO-20130207-907830.html?mod=crnews
Sources:
http://online.wsj.com/article/PR-CO-20130207-907830.html?mod=crnews
No comments:
Post a Comment