Volcano Corporation Announces First Commercial Implantations of Crux® Vena Cava Filter

SAN DIEGO, Nov. 13, 2013 /PRNewswire/ -- Volcano Corporation (NASDAQ: 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 commercial release and initial implantations of its innovative Crux^® Vena Cava Filter (VCF) in patients at risk for recurrent pulmonary embolism (PE). It is the only filter with a double helical design that self-centers to help prevent filter tilt and offers the Bi-Trieval™ option of retrieval via either the jugular or femoral vein.

The first U.S. implantations of the Crux VCF were performed by:

• Jeffrey D. Girardot, M.D., chairman of the Department of Radiology at Edward Hospital & Health Services in Naperville, IL
• Raghava Gollapudi, M.D., interventional cardiologist at Sharp Memorial Hospital in San Diego, CA
• Donald Jacobs, M.D., chairman of the Department of Surgery at Saint Louis University School of Medicine in St Louis, MO
• David W. Trost, M.D., associate professor of Clinical Radiology and director of Interventional Radiology at the Weill Medical College of Cornell University in New York, NY

"The Crux VCF is an important development in the prevention of recurrent PE. It was designed to address several limitations associated with filters to date, including the central problem of filter tilt, which can make device retrieval challenging, as well as migration of the filter to other areas of the body, and penetration through the wall of the inferior vena cava," said Dr. Girardot. "The design also allows for retrieval of the filter through either the femoral or jugular vein. This is a particularly beneficial feature in today's healthcare environment, where there is an increased clinical focus on removing filters from patients when the risk of PE has been effectively reduced."

PE, which is caused by migration of a large blood clot arising from the deep veins of the legs, a condition known as deep vein thrombosis (DVT), affects approximately 600,000 patients and results in an estimated 200,000 deaths annually in the United States.ⁱ Filters that are implanted in the inferior vena cava (IVC), the large vein that carries de-oxygenated blood from the lower half of the body into the right atrium of the heart, are an important tool in helping  prevent potentially deadly PE in patients for whom anticoagulation is contraindicated or ineffective.

"Study data regarding the Crux VCF suggests that it is very successful in addressing the problem of filter tilt commonly associated with other commercially available IVC filter technologies. Filter tilt is a main reason why filter retrieval has proven challenging, given that the hook is often embedded into the vena cava wall," said Dr. Gollapudi.

The U.S. Food and Drug Administration (FDA) recommends that removal of an IVC filter be considered as soon as protection for PE is no longer necessary, and as soon as the removal of the filter is both feasible and clinically indicated.ⁱⁱ  Published literature documents a retrieval rate of only 20 to 50 percent, with a mean retrieval rate of approximately 34 percent.ⁱⁱⁱ Prolonged filter retention is associated with adverse events, including filter fracture, filter migration, filter embolization and IVC perforation.ⁱⁱ 

"We worked for many years to develop the Crux VCF, and I am thrilled that it is now on the market in the United States, where we believe it can make a difference in reducing risk for recurrent PE, which is often fatal," said Thomas Fogarty, M.D., an internationally renowned cardiovascular surgeon and founder of Crux Biomedical, which developed the Crux VCF and was acquired by Volcano in late 2012. "The Crux VCF represents the first major design innovation for IVC filters in decades. Its unique self-centering design addresses the risks of migration and tilt, provides filtration across the entire lumen of the vessel, and provides for the Bi-Trieval™ option of either femoral or jugular retrieval."

"The Crux VCF is a cutting-edge therapy that meets an identified clinical need to improve the rate of IVC filter retrievals," said Neil Hattangadi, M.D., vice president and general manager of Volcano's Peripheral Vascular Business Unit. "This milestone represents one of many recent developments at Volcano that demonstrates the company's commitment to expanding our peripheral product offering and building on our heritage in diagnostics to deliver new therapeutic solutions for the patients and physicians we serve."

About the Crux Vena Cava Filter

The Crux Vena Cava Filter is designed as a non-conical, double helix. This double helical, symmetrical design helps prevent filter tilt, as the helical design self-centers automatically within the vena cava upon deployment. It is the only IVC filter that accommodates a bi-directional approach for both deployment and retrieval.ⁱⁱⁱ

The safety and effectiveness of the Crux VCF was evaluated in the RETRIEVE 2, 3 and 4 pivotal clinical trials, which enrolled 125 patients at high risk for PE across 22 global sites.^iv Results demonstrated high rates of both successful filter deployment (98 percent) and retrieval (98 percent). The mean time for filter deployment was 5 minutes, and the mean time for filter retrieval was 7 minutes, with the approach occurring by femoral access in 85 percent of deployment cases and 70 percent of retrieval cases. Results also showed high rates of safety and effectiveness, with 0 percent embolization, migration (>2cm per SIR guidelines) and filter fracture or filter tilting, and no device-related adverse events requiring intervention reported.

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 that 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.

ⁱ American Public Health Association. Deep-Vein Thrombosis: Advancing Awareness to Protect Patient Lives. White Paper. Public Health Leadership Conference on Deep-Vein Thrombosis, Washington, D.C., February 26, 2003.  http://www.apha.org/NR/rdonlyres/A209F84A-7C0E-4761-9ECF-61D22E1E11F7/0/DVT_White_Paper.pdf. Accessed November 8, 2013.

ⁱⁱ U.S. Food and Drug Administration. Safety Alerts for Human Medical Products. August 2010.

ⁱⁱⁱ Ni H, et al. Retrievable inferior vena cava filters for venous thromboembolism. ISRN Radiology. 2013; Article ID 959452:1-8.

^iv Smouse HB, et al. The RETRIEVE Trial: Safety and effectiveness of the retrievable Crux Vena Cava Filter. J Vasc Interv Radiol. 2013; 24:609–62.

SOURCE Volcano Corporation

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