Within minutes a thin, flexible wire will be snaked up the aorta to the
heart, entering the coronary arteries, where balloon angioplasty will be
performed to provide dilation of the artery.
In all of mankind’s existence, an acutely blocked coronary artery has
been a certain path to the grave, but since the 1980s, cardiologists have
been able to stand next to a human body in a cath lab, and manipulating
the controls at the end of a wire, unclutter a small artery with an inflatable,
tiny balloon and prop it open with a springy-cage metal alloy stent that
expands upon command. All the details of polymer IVs, sterile drapes,
fluoroscopy (live-motion X-rays), specialized packaging, and anesthesia
are similar for all such interventions, and become so routine and
dependable that we forget what a sensation each one is. But it is typically
the implant itself that garners the greatest attention. While there are data
now that question the wisdom of stenting arteries in patients who are not
experiencing an acute heart attack and have little or no chest pain but who
have an abnormal EKG—it is clear that there is, and will be, a huge
worldwide market for stent placement under properly indicated situations.
The vast array of materials available to scientists, including polymers,
metals, and space-age electronics (saying nothing of the innovations in
organic and biologic implants), combined with advanced manufacturing
and packaging processes, has altered the way that companies approach
acute and chronic diseases. Among implant manufacturers, similar to the
pharma industry, market analysis drives research and consideration of
device innovation. If the numbers justify an investment, a working group
of scientists and physician consultants will be formed, hoping that in a few
years’ time, after thousands of hours of development, a technical
breakthrough with market potential and clinical impact will have been
achieved. Usually, such a project leads to failure, as it is extremely
difficult to invent a new device that: 1) works, 2) is safe, 3) is novel, 4) is
capable of being reliably manufactured, 5) would yield a profit, and 6)
doesn’t infringe upon someone else’s patent.
If a sort of miracle has occurred, a medical device invention will
change lives and achieve financial success. As has been argued in this
book, America is embarrassingly behind the times in tracking implants in
device registries, but we must face the facts, and, in the process, achieve
greater patient safety and efficacy, and in turn, drive greater device
innovation and better health outcomes (with or without devices). It’s
marcin
(Marcin)
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