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Volcano Announces Upcoming Data Presentations from Large-Scale Studies on Physiology and Imaging Technologies at TCT 2013
Company to have strong presence at TCT 2013 with new iFR/FFR data from ADVISE II and analysis of IVUS use in ADAPT-DES featured in scientific program
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iFR will be one of the technologies highlighted by Volcano at this year's TCT |
October 27, 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 several significant clinical data presentations and other activities related to its physiology and Intravascular Ultrasound (IVUS) technologies at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, being held in San Francisco from October 27 to November 1.
The data include final results from the ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation) Registry, which will be presented in a Late-Breaking Clinical Trials session on October 30. The prospective, 40-center, global registry evaluated the diagnostic utility of a combined instant wave-Free Ratio™ (iFR®)1 and Fractional Flow Reserve (FFR) workflow to reduce the need for hyperemic agents in patients with intermediate or unclear lesions. Additionally, a first look at two-year outcomes from an analysis of use of IVUS in the ADAPT-DES Study, the largest prospective registry of IVUS use to date, will be presented in an oral session. This registry of more than 8,000 patients evaluated the use of IVUS in placing the current generation of drug-eluting stents and its ability to reduce stent thrombosis and impact other clinical outcomes.
"FFR, iFR and IVUS are technologies that we believe can improve both appropriateness and quality in the diagnosis and treatment of coronary and peripheral vascular disease. However, they are not used as often as they could be," said Scott Huennekens, president and chief executive officer of Volcano Corp. "The new data being presented at TCT 2013 reflect the evolution of our significant investment in clinical science over the last several years, and will help guide physicians in making important patient care decisions. With the approval of our iFR modality in Europe and Japan and the U.S. launch of the new Verrata™ Pressure Guide Wire, our goal is to further simplify workflows so that these advanced technologies become a faster, simpler and more routine part of everyday practice and can benefit more patients."
Volcano will display its products and technologies at Booth 1104, Exhibit H., including three new launches:
- Verrata™ Pressure Guide Wire
- Crux® Vena Cava Filter
- iFR® modality (CE Mark countries and Japan only).
The company will also host a Breakfast Symposium that will showcase data from ADVISE II and the ADAPT-DES IVUS analysis, and review the upcoming SYNTAX II study. Specific details follow.
Key Presentations in the Scientific Program
Tuesday, October 29, 1:15 p.m.
Does IVUS Reduce Stent Thrombosis with DES? Two-Year Results from the Prospective, Multicenter ADAPT-DES Study
Presented by Akiko Maehara, M.D.
Moscone West, 2nd Floor, Room 2010
Wednesday, October 30, 1:54 - 2:06 p.m.
A Prospective, Registry Evaluation of iFR vs. FFR: ADVISE II*
Presented by Javier Escaned, M.D., Ph.D.
Moscone North, Lower Level, Hall D, Coronary Theater
*First Report Investigation
Volcano-Sponsored Breakfast Symposium
Putting Appropriateness Within Reach: New Global Clinical Data and Workflows
Thursday, October 31
The Moscone Center, Moscone North, Lower Level, Room 132
7:00 a.m.
State of the Union on Global PCI Guidelines Today and Where to Expand in the Future
Manesh Patel, M.D.
7:10 a.m.
New and Future Instant Wave-Free Ratio™ (iFR®) and IVUS data: ADVISE II and SYNTAX II
Javier Escaned, M.D., Ph.D.
7:20 a.m.
ADAPT-DES: Two-Year Insights from the Largest IVUS Substudy Ever
Bernard Witzenbichler, M.D.
7:30 a.m.
A More Functional Future: Moving Physiology From Justifying to Deciding Treatment
Justin Davies, M.D., Ph.D.
7:40 a.m.
Functional PCI: An Efficient Workflow for Today and Tomorrow
Bruce Samuels, M.D.
7:50 a.m.
Closing Remarks
Manesh Patel, M.D.
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.
[1] IFR modality is available in CE mark countries and Japan; not commercially available in the United States.
Source: Volcano
Corporation
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