Biomedical Engineering Reference
In-Depth Information
upcharges of 10±20% for new technological features, such as the Magna
TM
design or the Thermafix
TM
process (Mussallem, 2006), these prices fall far
short of the US$30 000 they are projecting for the sale of a percutaneous valve
system (Wood, 2009). It is no wonder that the development of the Edwards'
percutaneous valve system has generated tremendous interest among investors
and no fewer than a dozen start-up companies have begun to develop their own
versions of percutaneous valve technology. When Medtronic announced the
purchase of start-up valve company CoreValve in February 2009 for $700
million (Beach, 2009), it was clear that investors want percutaneous valve
technology to reach commercialization and that they are willing to take the
risks and make the investments required to do so. Figure 5.21 illustrates two of
the leading second-generation percutaneous valves that have begun clinical
investigation. Both valves enable the physician to reposition the valve prior to
final deployment, thereby ensuring an optimal placement of the valve in the
aortic position.
5.8.2
Tissue engineered valves
While tissue engineering is being covered in Chapter 10, a few words are
warranted here, in light of the discussion on percutaneous valve technologies.
A reality of new technology development is that there has to be some
financial reward for the investors who bravely invest the time and money in a
new concept and support the company as it works through the hurdles and
setbacks intrinsic in new technology development (Cardis et al., 2001). Most of
the investment dollars for new technology comes from venture capital firms,
which are, in turn, paid to invest others' money and generate an extraordinary
rate of return that would not be achievable in more conventional investment
methods. As such, venture capitalists must show their partners a return on their
investment within some reasonable period of time, say 5 to 10 years. This makes
it difficult for traditional money sources to support the development of
paradigm-shifting new technologies like tissue engineering, where
commercialization is still decades away, particularly for a tissue engineered
heart valve.
So it is unlikely that you will see the excitement and fervor around tissue
engineered heart valves as you see around percutaneous valves, at least for some
period of time. This is despite the fact that a tissue engineered heart valve will
likely contribute more significantly to the treatment of valve disease than any
other technology, and it has the ability to provide a real cure to the problem,
particularly in children. Currently children with congenital or acquired valve
disease are subjected to suboptimal treatments with valves developed for adults.
As they grow, they must endure repeated open heart surgeries to replace the
implanted valves with larger valves. Also, because children are rapidly growing,
including their bones,
they rapidly calcify traditional bioprosthetic valves.
