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iFR Can Reduce Use of Adenosine, Saving Time and Costs in Assessing Need for Stents
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November 4, 2013 -- Three major studies have now shown that functional measurement of blood flow during percutaneous coronary interventions (PCI), such as angioplasty and stenting, improves outcomes and reduces the numbers of stents used.
When Fractional Flow Reserve (FFR) has been used as a decision-making tool in the DEFER, FAME and FAME II studies, the use of stenting declined by one-third, saving costs for the healthcare system and significantly improving outcomes for patients. One drawback to FFR, however, is that a vasodilator, such as adenosine, must be given to the patient to measure the blood flow accurately: this increases costs and often causes discomfort for the patient. In some circumstances, such as myocardial infarction and unstable angina, adenosine cannot be used, making it impossible to measure the FFR at all.
In the past few years, however, a new measurement has been developed by researchers in London and is being commercialized by Volcano Corporation (NASDAQ: VOLC). Called iFR (Instantaneous wave-Free Ratio) a functional measurement of ischemia in an artery can be performed very quickly and without need for a vasodilating agent. Multiple and serial blockages can be measured within seconds, extending the utility of functional measurement to types of procedures that previously could not be assessed.
The question of whether or not iFR was as accurate as FFR has remained a controversial topic, and has resulted in spirited debate at recent medical symposia on the subject. However, at last week's Transcatheter Cardiovascular Therapeutics (TCT) meeting, the two-year results of the ADVISE II Registry were presented, and iFR showed 94.2% agreement with FFR measurements. Furthermore, the use of an iFR/FFR hybrid approach in patients (where adenosine-FFR measurements were done only in cases where iFR was shown to be equivocal) avoided the use of adenosine in two-thirds of the procedures.
As reported during the EuroPCR meeting in May, the iFR/FFR hybrid approach will be utilized in the upcoming SYNTAX2 Trial; other iFR clinical studies are ongoing as well. iFR has received the CE Mark but is not approved for use in the United States. Volcano is anticipating FDA approval and marketing of iFR in the U.S. sometime in the second half of 2014.
Thursday's press release from Volcano Corporation follows:
Volcano Announces Final Results of ADVISE II Registry, Prospectively Demonstrating Performance and Utility of iFR® Modality to Measure and Document Severity of Intermediate Coronary Blockages
New data from prospective, global, multicenter, double-blind ADVISE II Registry presented during Late-Breaking Clinical Trials Session at 25th Annual TCT Scientific Symposium
October 30, 2013 -- San Diego -- Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision guided tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced final results of ADVISE (Adenosine Vasodilator Independent Stenosis Evaluation) II, a prospective, double-blind, global, multicenter registry designed to investigate the diagnostic utility of the instant wave-Free Ratio™ (iFR®) Modality in assessing the severity of coronary stenosis. These final results replicate earlier findings and show that the hybrid iFR/FFR (Fractional Flow Reserve) approach correctly matched an FFR-only approach in 94.2 percent of coronary stenoses and successfully avoided use of adenosine in 65.1 percent of patients.
"I believe that the more physiology we can use to guide our patient therapy, the better," said Amir Lerman, M.D., co-principal investigator of ADVISE II and professor of medicine at the Mayo Clinic in Rochester, Minn. "Study data has suggested that FFR is associated with improved patient outcomes when used to help decide whether coronary vessels with stenosis require revascularization with stents or other treatment strategies. However, its use in clinical practice remains low, partly due to the requirement for adenosine administration. For this reason, I believe that the development and potential availability of iFR as an adenosine-free partner to FFR can be a significant development in the field of coronary physiology."
He added, "ADVISE II is the first prospective study with scientifically rigorous methodology to investigate the diagnostic utility of iFR in assessing coronary stenosis relevance in patients who represent a real-world population, providing evidence for the clinical value of the hybrid iFR/FFR approach. These results may help solve what I perceive as the underutilization of physiology in the cath lab. I believe that iFR is worth considering given that the ADVISE II data have shown a 94.2 percent match with FFR and removed the need for hyperemic drugs in 65.1 percent of cases."
The hybrid iFR/FFR approach is possible with the Volcano system because both measurements take place on the same pressure guide wire. In the hybrid workflow, iFR measurement is generally made in seconds after positioning the standard Volcano pressure guide wire.
"The goal of our iFR project from the beginning has been to remove barriers that prevent physicians from receiving the valuable information that physiology provides," said Joe Burnett, executive vice president and general manager of Volcano's Functional Management Business. "In an environment where proper documentation and appropriate use criteria are helping to standardize treatment patterns around the world, angiography can be a rate-limiting factor because interpretation of angiographic images is inherently subjective. One physician may interpret a lesion as 75 percent blocked based on the angiographic image and another physician may review the same image and interpret the lesion as only 50 percent blocked. Tools such as iFR and FFR provide an objective measure. An FFR of 0.67 entered in the patient record will remain an FFR of 0.67, no matter who is reviewing that case down the road."
Burnett added, "ADVISE II is important because it shows that the retrospective performance of the iFR algorithm has now been confirmed in a controlled, prospective manner at 40 global centers with many different users. This represents the final stage in our validation of iFR compared with other physiologic indices and gives us the confidence to move forward with a series of outcome studies where iFR will contribute to clinical decision making live in the cath lab , including the SYNTAX II trial and the DEFINE family of studies."
The iFR modality is currently approved for use in Japan, CE Marked, and is activated at more than 100 global sites. iFR is not commercially available in the United States; it is 510(k) pending.
About Volcano Corporation
Volcano Corporation is revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information - using sound and light as the guiding elements. Founded in cardiovascular care and expanding into other specialties, Volcano is changing the assumption about what is possible in improving patient outcomes by combining imaging and therapy together.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered "forward-looking statements." including statements regarding the potential benefits of the products and technologies described above, further development and expansion, anticipated clinical trials and the impact of clinical and other technical data. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause Volcano's results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ include the pace and extent of market adoption of the company's products and technologies; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; growth strategies; timing and achievement of product development milestones; outcome of ongoing litigation; the impact and benefits of market development; product introductions; unexpected new data, safety and technical issues; market conditions; and other risks inherent to medical device development and commercialization. These and additional risks and uncertainties are more fully described in Volcano's filings made with the Securities and Exchange Commission, including our recent quarterly report on Form 10-Q. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
** iFR is CE Marked and 510(k) pending. It is not available for sale in the United States **
Reported by Burt Cohen, November 4, 2013; revised November 5 with addition of approval timeline
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