SAN FRANCISCO, Sept. 23 /PRNewswire-FirstCall/ -- Volcano Corporation , a leader in the development, manufacturing and sales of products for the diagnosis and treatment of coronary and peripheral artery disease, said today that the two-year results of the Fractional Flow Reserve (FFR) vs. Angiography for Multivessel Evaluation (FAME) study confirm the importance of FFR in improving patient outcomes and reducing hospital costs. The findings were released today during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.
William F. Fearon, M.D., associate director of interventional cardiology at Stanford University Medical Center, Palo Alto, California commented, "Use of FFR technology represents a rare opportunity in medicine in which an innovative product not only improves clinical outcomes but also saves money."
FAME randomized 1,005 patients diagnosed with multi-vessel coronary artery disease at 20 European and United States centers to either angiography-guided PCI (n=496) or FFR-guided PCI (n=509) all using current drug regimens. Some physicians have been concerned that the lesions deferred by FFR may progress and cause future events. In the FAME study, 513 total lesions were deferred and only one of those lesions led to a myocardial infarction (heart attack) within two years (0.2 %). This highlights the effectiveness of using a 0.80 FFR threshold for triaging this multi-vessel disease patient population.
Volcano estimates that multi-vessel disease is treated in approximately 35% of all U.S. PCI (a combination of mutli-vessel stenting and patients who are staged and treated during two separate visits). By applying the FAME results across that patient population, the reduction in MACE and assuming $675 per procedure cost savings would result in approximately 18,000 fewer MACE events per year at a total hospital cost savings of approximately $230 million or over $2 billion in the 10 years outlined for the new healthcare reform package. If you count the cost savings included in the MACE reductions, as presented at ESC 2009 ($2,066 per patient) that potential total cost impact could be more than $700 million per year, and $7 billion over 10 years.
About Volcano Corporation
Volcano Corporation offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab. Volcano IVUS offers unique features, including both single-use phased array and rotational IVUS imaging catheters, and advanced functionality options, such as VH(R) IVUS tissue characterization and ChromaFlo(R). Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires and is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) and Forward-Looking IVUS systems and catheters. Currently, more than 4,400 Volcano IVUS and FM systems are installed worldwide, and more than half of Volcano's revenues are derived from outside the United States. Through its wholly-owned subsidiary, Axsun Technologies, Volcano also develops and manufactures optical monitors, lasers and optical engines used in telecommunications, spectroscopy and other industrial applications. These products are sold to a variety of customers, including Nokia Siemens, Ericsson, Alcatel-Lucent and HuaWei Technologies. For more information, visit the company's website at http://www.volcanocorp.com.
Volcano Corporation
