Statement by Volcano President and Chief Executive Officer, Scott Huennekens, on Public Discussion Surrounding Former President George W. Bush's Stent Procedure

Aug 09, 2013, 20:21 ET from Volcano Corporation

SAN DIEGO, Aug. 9, 2013 /PRNewswire/ -- "On behalf of all my colleagues at Volcano Corporation (NASDAQ: VOLC), I send former President George W. Bush best wishes for a speedy recovery and a return to the active lifestyle that has set a powerful example for our nation and provided inspiration to millions of Americans.

The disclosure of health conditions by public figures offers an opportunity to drive awareness and dialogue around critical health issues of concern to us all. Every year, about 715,000 Americans have a heart attack, and about 600,000 people die from heart disease in the United States each year.[i] That is one out of every four deaths, making it the leading cause of death for both men and women in the U.S. There has been significant public debate as to whether the procedure in this case was medically necessary or followed well-established clinical guidelines on the use of stents to open heart vessel blockages in patients with stable disease. This discussion is particularly important because the placement of unnecessary stents can pose serious safety concerns and potentially long-term repercussions for patients who receive them.

Volcano is committed to educating the physician community and the public at large about the clinical and economic benefits of Fractional Flow Reserve (FFR), a brief diagnostic test that is widely available to cardiologists in catheterization laboratories across the country to provide quantitative measurement of a blockage to help cardiologists in determining whether to stent – establishing documentation of the need or absence of need to stent and ultimately helping to drive better patient care.

In certain clinical studies, the use of FFR was associated with improvement in patient outcomes.[ii] Additional studies have demonstrated that the use of FFR was associated with changes in diagnostic decisions for patients nearly half the time when compared to assessment using visual modalities such as angiography.[iii] From a financial perspective, a study has shown that use of FFR reduced stent use by one-third as compared to use of angiography alone.[iv] In short, we believe that using FFR can offer a rare opportunity to improve clinical outcomes and save money.

Despite these facts, we do not believe that the adoption of FFR has been commensurate with this evidence and clinical experience. If we are to achieve the desired goals of providing appropriate treatment, improving patient outcomes, and reducing our nation's medical bill, we must ensure that beneficial, safe and cost-effective technologies such as FFR are being utilized in cases where their use is medically appropriate."

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 light and sound 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. For more information, visit the company's website at

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 FFR use. 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: unexpected new data, safety and technical issues 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.

i ii Tonino PA, et al. FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. iii Van Belle, E., et al. Impact of the use of FFR on the coronary revascularization strategy: insights from a large French multicenter FFR registry. Archives of Cardiovascular Diseases Supplements (2011) 3, 1-25. iv Fearon WF, et al. Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) Study Investigators. Economic evaluation of fractional flow reserve-guided percutaneous coronary intervention in patients with multivessel disease. Circulation. 2010 Dec 14;122(24):2545-50.

SOURCE Volcano Corporation