From a patient and clinician perspective, intravascular imaging catheters and pressure guidewires only mean good things for coronary stent procedures. You can more accurately identify stenting candidates? Great. You can better select the correct size and length of stent to use, and you?ll have a better idea of exactly where to put it? Wonderful. You can easily find out if the stent has been correctly placed? Fantastic.
Nonetheless, from an industry standpoint, things are less obviously rosy. Fractional flow reserve (FFR) guidewires have become somewhat the bane of the interventional cardiology (IC) device market. Because FFR guidewires have allowed physicians to better place stents and identify stenting candidates, fewer stents are being used overall. Given that stents are what generate the majority of revenues in this market, this has been less than ideal from a sales perspective for IC device manufacturers. Now, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) catheters are a different story. These products can actually improve procedural outcomes, allowing physicians to treat more complex cases. So, overall, the industry has kind of a love-hate relationship with these products.
What's interesting though, is how different the game is depending on what geography you?re playing in. For example, we recently had the chance to look into the use of these products in Japan. IVUS catheters have phenomenal adoption in the country?they?re used in more than 80% of percutaneous coronary interventions (PCIs). Contrast this to the US and Europe, where they?re only used in about 15% and 5% of procedures, respectively. Japan has actually become a model for IVUS catheter use because many physicians have noted that the Japanese legs of stent clinical trials tend to outperform those of other geographies. Why is adoption so much better in Japan? It seems to just come down to the fact that Japanese regulatory bodies were quick to grant reimbursement for IVUS catheters.
Interestingly, because adoption of IVUS catheters picked up so rapidly in Japan, FFR guidewires suffered. By the time they got reimbursement, IVUS catheters had already had reimbursement for about 2 years, and physicians didn?t really see the need to use both of these products. As a result, FFR guidewires were used in about 5% of PCIs in Japan, compared to about 10% in Europe and 15% in the US. The use of these products might pick up a bit, however, because these products recently received reimbursement coverage for use in diagnostic angiographies?where you wouldn?t use IVUS catheters?allowing FFR guidewires to find their own niche. OCT catheters, as is the case in all geographies, continue to struggle for relevance against IVUS catheters, which are largely used for the same purposes.
The low adoption of FFR guidewires and high adoption of IVUS catheters might?ve made the Japanese market seem, at a glance, more attractive to stent manufacturers than the US, which is all in an uproar about the overuse of stents. But don?t forget those pesky biennial reimbursement cuts, which are continuing to slash prices and profit margins dramatically.
What might strike you overall is that the use of intravascular imaging catheters and pressure guidewires is still low on a global scale. While it's increasing, adoption is still remaining stubbornly slow
for a technology everyone agrees is great. Will adoption take off soon? From a patient's perspective, I hope so.