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August 9, 2010 -- 10:14pm PDT

The Un-Stent Wars: Call Out the Fractional Flow Reserves
Fractional Flow ReserveFFR (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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