BARCELONA, Spain – The gamble for every device manufacturer is whether a clinical trial will help or hinder adoption, and subsequent sales.
Sometimes trial results will move markets, or in the case of Radi Medical Systems (Uppsala, Sweden), a new technology can redefine medical practice and set off a seismic shift.
Nothing has been the same since Radi released results testing its PressureWire device in the FAME trial, the Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation.
Between the October 2008 presentation at the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington and the publication in January 2009 of results in the New England Journal of Medicine, Radi was acquired by St. Jude Medical (St. Paul, Minnesota), developed a second-generation device, and saw an aggressive competitor enter a market it had comfortably enjoyed.
At EuroPCR, held here last week, interventional cardiologists still were abuzz over the FAME trial at their first gathering since publication and both the Radi/St. Jude and Volcano Corp. (San Diego) booths were enjoying the interest, and the traffic, as these hands-on physicians came to play with the demonstration models.
John Ryott, who until recently was director of marketing for the former Radi and now is part of the St. Jude team, said that angiography, the dominant imaging modality for a transcatheter cardiac intervention, "provides a 2-D view of a 3-D problem."
By placing a micropressure sensor at the distal tip of the catheter, he explained, the physician now can take a measure of the pressure beyond the narrowing of an artery and measure the difference with the aortic pressure flowing through clean vessels upstream of the stenosis.
Where the pressure drops by a significant factor of 20% to 25%, the interventionalist may decide to place a stent.
The advantage of the PressureWire is that multiple lesion sites in the same artery can be measured to guide a decision for multiple stenting.
The FAME study showed FFR measures resulted in one-third fewer stents being used than with interventionalists looking only at angiography, a significant cost savings, and that after one year patients treated with FFR guidance experienced "significantly reduced" major adverse cardiac events (MACE).
One-year follow-up showed that within the traditional group, 18.4% of the patients had died, suffered a heart attack or needed a bypass surgery or repeat stent procedure, compared with 13.2% among those who received the additional pressure wire test.
St. Jude noted that in the study, the risk of a patient dying or having a heart attack was reduced by about 35% when FFR measurement was performed (11.1% for the angiography-guided group compared to 7.3% for the FFR-guided group).
The added benefit is that PressureWire uses a standard guide wire and can be used to measure and then to stent.
At EuroPCR, St. Jude was demonstrating a second generation, wireless version of PressureWire that reduces the device to a lightweight handle the size of an electric toothbrush.
Simultaneously, St. Jude was promoting the integration of this next-generation device, PressureWire Aeris, with the Mac-Lab cath lab suite from GE Healthcare (Waukesha, Wisconsin) which puts the FFR measures up on the screen in front of the interventionalists instead of on a stand-alone monitor off to the side.
"It's true that the requirement for a stand-alone monitor for the PressureWire Certus product can be a barrier to sales," acknowledged St. Jude's Ryott, or as one doctor said of the new system, it provides greater accessibility to FFR measures.
Ryott said that GE has an installed base of more than 2,000 Mac-Labs which should provide a significant boost for marketing the PressureWire Aeris.
In mid-April, St. Jude CEO Daniel Starks reported that the company's cardiovascular business grew more than 21% during the first quarter, including strong double-digit organic growth for the newly acquired PressureWire product lines.
"We have revitalized our cardiovascular franchise and going forward we expect to deliver double-digit sales growth on a sustainable basis," he said.
Revenues from Radi contributed $20 million for 1Q09, which may be the last break-out figures as the acquired business is blended into the St. Jude larger cardiovascular business.
The reduction in sales of the stand-alone units in favor of the hand-held wireless will place a heavier emphasis on the considerable revenues generated from disposables, such as the single-use catheters.
Volcano erupts in vascular guidance
Figures from the publicly traded Volcano, where FFR is called "functional measurement" (FM), are more transparent and CEO Scott Huennekens told industry analysts just weeks ahead of EuroPCR the FAME study from Radi "continues to have a highly positive impact on our FM business."
He said the FM option for Volcano's cath lab consoles "was included in nearly all of our new orders during the quarter, and we've started to see the positive effect of this data on our FM business in 2009 as we anticipated."
Huennekens said revenue growth in 1Q09 was driven by a 24% increase in revenues from its intravascular ultrasound (IVUS) business, with 210 consoles placed during the quarter vs. 112 consoles sold in the same year-earlier quarter.
He said FM revenues were $3.6 million for the quarter and that while adding the FM capability was driving up cost, the company had projected upgrade or sales of 1,500 FM-equipped consoles for the year, "and we are running a bit ahead of that, which is a good thing."
Laurence Bezu, a former radiologist who is a sales representative for Volcano in France said, "the nice thing about FFR is that it gives a result, a functional reading."
By contrast, she said, to a great extent IVUS remains dependent on the experience and skill of the operator, making diagnostics more subjective.
"With FFR the results tell the interventionalists either 'go' or 'no-go,' and you can not get a more clear message in medicine than that," Bezu said.
The FAME study, she said, "gave a real boost to us for sales, and it was our competitors' study, they paid for it!"
Huennekens told MDD that in the nascent market for FFR, "Globally the market is probably a 60% share for Radi and 40% for Volcano. In Europe it is probably between 65% and 70% for Radi. In the U.S., we are at 50-50 and the same in Japan."
Volcano entered the FFR business at TCT 2008 even as the FAME study was being presented.
The Volcano PrimeWire integrates with the company's installed base of s5 and s5i imaging consoles consoles for IVUS imaging that the company says is now greater than 3,700 units worldwide with half of those sales coming from outside the U.S.
The Volcano FFR technology can also be integrated on major cardiovascular cath lab systems, such as GE, Siemens (Erlangen, Germany) and Phillips Healthcare (Eindhoven, the Netherlands), said Huennekens.
"It is only a question of pushing a signal to their monitor, not a really big deal," he said.
The FFR and IVUS capabilities will be joined on the Volcano consoles by a third vascular guidance capability, optical coherence tomography (OCT) following the acquisition of Axsun Technologies in January.
"We're the only company that will have all vascular guidance modalities on one platform," Huennekens told MDD, adding, "It's why we are now winning 70% to 80% of the new placements for cath labs."
The initial launch of an OCT offering will take place in Europe in mid- to late-2010, he predicted.
"Given the breadth and scope of this technology, our biggest challenge will be prioritizing market development opportunities such as imaging and analytical devices for peripheral vascular, neuro, pulmonary, ophthalmology, cancer detection, blood glucose monitoring among others," Huennekens explained to analysts.