Healthcare Industry News: fractional flow reserve
News Release - October 23, 2012
Volcano Announces Global Launch of PrimeWire Prestige(R) PLUS Pressure Guide Wire with AcuSense(TM) TechnologyProduct To Be Used in Six New Clinical Trials
SAN DIEGO, Oct. 23, 2012 -- (Healthcare Sales & Marketing Network) -- Volcano Corporation (VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced the global launch of the PrimeWire Prestige® PLUS pressure guide wire with AcuSense™ technology, which allows for more precise measurements when distal pressure is monitored for longer periods of time. The new offering is the fourth new pressure guide wire from Volcano in four years and will serve as the platform for Volcano's expanding clinical programs. The PrimeWire Prestige PLUS product will be used in six newly announced Volcano-sponsored clinical studies to explore new indications in stable and unstable CAD, peripheral arterial disease and neurology.
"FAME and now FAME 2 are landmark studies showing how measuring pressure gradients across coronary narrowings can help to improve our treatment strategy for patients," commented Bruce Samuels, M.D., of Cedars-Sinai Hospital in Los Angeles. "We always have been able to see the anatomic outlines of coronary narrowings. However, the ability to now make live pressure measurements enables us to finally understand their functional significance. This technology has galvanized the interventional community and has dramatically improved our ability to provide appropriate care for our patients. It is our role as clinicians to continue to find ways to improve outcomes and make the patient record more complete. Our work with fractional flow reserve (FFR) and other indices will continue to move PCI forward, and help us apply those same principles to similar challenges outside of the heart."
"Our belief is that monitoring distal physiology, such as FFR, throughout a PCI procedure provides more precise information than angiography alone can offer," commented Joe Burnett, executive vice president and general manager of the Functional Management business at Volcano. "Our product focus is on fast, simple and reliable measurements, and the AcuSense technology further simplifies the physician workflow by reducing the need to re-calibrate during those longer procedures. Physicians can now measure distal pressure at baseline, deliver their therapy over the wire, then re-measure at the conclusion to document the impact the therapy had, or the 'functional improvement' in the permanent patient record. There are more than 5 million guide wires used every year alongside angiography, and we are designing our products to be fast and simple enough that they can add a new dimension to x-ray imaging alone, and relay distal physiology data, as well."
"Volcano's pressure sensors with AcuSense technology are proprietary Volcano designs and have been evaluated at every step, from bench-top testing to human evaluation," added Mr. Burnett. "PrimeWire Prestige PLUS pressure guide wires with AcuSense technology are now shipping to customers in the U.S., Europe, Japan and beyond, and will be the catalyst for our global studies showcasing the benefit of distal pressure sensing in numerous coronary and non-coronary applications."
"New technology often leads to unlocking new clinical indications," commented Jasvindar Singh, M.D., of Washington University School of Medicine in St. Louis. "A precision miniature sensor at the end of a frontline guide wire is a tool that has eluded interventionalists historically. Now we can use this tool to learn more about coronary and peripheral artery disease, and the ease of use opens the door for more researchers to participate."
The PrimeWire Prestige PLUS guide wire will be used in six current and up-coming Volcano-sponsored clinical trials including ADVISE II and the DEFINE family of studies (Distal Evaluation of Functional significance of Intra-arterial stenosis Narrowing Effect). These studies will further explore clinical and economic outcomes impacted by FFR, coronary flow reserve (CFR), instant wave-free ratio™ (iFR®) and other physiologic indices.
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.
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 procedures described above, further development and expansion, regulatory approval, commercial release and market adoption of the company's technology, 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.
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