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August
9,
2010 -- 10:14pm PDT
The Un-Stent Wars: Call Out the Fractional
Flow Reserves
FFR
(Fractional Flow Reserve) is a technology I've written about many
times.
You can read about it in depth in our
article, "Fractional
Flow Reserve". It's been around for a while. In fact, in
a different form, the FFR concept was a key
component of Andreas Gruentzig's original 1977 balloon angioplasty
catheter.
But interest in FFR has taken off since
the results
of the FAME study were published back in January 2009. (FAME demonstrated
that by measuring the differential in blood pressure across a blockage
inside the
coronary arteries, a more accurate assessment could be made as
to whether or not to stent the narrowing -- more accurate when
compared to angiography alone. The results: almost 1/3 less major
cardiac events and 1/3 less stents implanted when FFR was used.)
FFR's efficacy was enhanced further when last November
the AHA/ACC/SCAI issued a Guidelines
Update that increased the level of evidence and
expanded the indications
for FFR.
So it would seem to be a no-brainer that during a coronary
angiogram, a small wire could be threaded across a blockage and the
need for a stent could be documented, relieving much of the anxiety
and malpractice accusations of "too many unnecessary stents!" --
or the wire could show that a stent was not needed, saving the healthcare
system a chunk of change. Another advantage of this technology for
interventional cardiologists was being able to demonstrate that in
complex 3 or 4 vessel disease, 1 or 2 of the narrowings were not
causing ischemia, thus the patient could be done effectively using
angioplasty and did not need to go through bypass surgery.
At the time FAME was first presented at the 2009 TCT,
only two companies manufactured FFR catheters: Volcano in San Diego
(Nasdaq: VOLC) and Radi Systems in Sweden. Radi in fact had sponsored
the FAME trial.
But shortly after the TCT and just before publication of FAME in
the New England Journal of Medicine, St. Jude Medical (NYSE: STJ)
acquired Radi Systems.
A captain of the device industry once told me that one
reason larger companies buy smaller companies was to obtain
their patents. And that's just how it played out a couple weeks ago
when St. Jude Medical,
a much larger device manufacturer than Radi or Volcano, filed
a lawsuit against Volcano, involving five different patents used in
St. Jude's (formerly Radi's) PressureWire® technology
platform. Volcano fired back, stating that the "claims
against it are entirely without merit, and looks forward to vindicating
its rights in court."
So the first "Un-Stent Wars" have begun: two companies
battling as to who's technology can rightfully show that a stent
is not necessary. One of Volcano's advantages is that their FloWire,
ComboWire and PrimeWire products all
work on an integrated platform with their IVUS and OCT intravascular
imaging products, and can now be integrated into all major manufacturers'
catheterization labs, saving time and money. St. Jude has been making
similar advances, but lacks the IVUS technology. St. Jude, however,
is a larger organization and it remains to be seen whether size matters,
as CNBC commentator Herb Greenberg opines in his piece, "Can
St. Jude Bigfoot Volcano?"
As they say, "stay tuned"....
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