Intravascular ultrasound combines a catheter with a tiny ultrasound widget on the end. Attached to a computer, an IVUS can show the inner lining of blood vessels.
It gives the physician a 360-degree fix on the plaque buildup inside the blood vessel. The technology can help determine if a stent is needed, and where exactly it should go.
But the technology has yet to get U.S. or European reimbursement. Insurers do pay for it in another big market -- Japan.
Despite the lack of reimbursement, Volcano has blasted past Wall Street expectations for 10 straight quarters. In its 2008 third quarter, revenue rose 40% from the year-ago period.
The firm reported nine-month revenue of $122 million, up 35%. Sales were propelled by a 78% year-over-year hike in IVUS system sales and a 29% boost in sales of related disposables.
By market region, revenue was up 40% in the U.S., 35% in Europe and 45% in Japan.
There's lots more opportunity, says Matt Dolan, an analyst at Roth Capital, which may seek Volcano's business.
Even without reimbursement, IVUS systems are used in just 15% of the 1 million annual U.S. cardiovascular procedures, says Jose Haresco, an analyst at Brean Murray.
"Volcano has been trying for several years to get reimbursement approval from the Centers for Medicare and Medicaid Services," he said.
Why no reimbursement? "Medicare says IVUS doesn't necessarily add immediate clinical value," Haresco said.
Volcano hopes to prove its case with data from real-life, marketplace cases. "More data is being generated daily," he said.
"IVUS' clinical value in complex cases makes a good argument that this should be the standard of care," Dolan said.
Just looking at that last line there, CCSVI is by definition a complex case. Multiple lesions in multiple veins. High degree of variations, all with the same result of outflow obstruction. The word for our veins is "tortuosities," it's a perfect word.
Perhaps CCSVI will be the disease that gets IVUS the reimbursement it deserves?