Volcano Corporation Announces CE Mark and 510(k) Clearance for New Visions® PV .035 Digital IVUS Catheter
10/4/2012 6:19:54 AM
SAN DIEGO, Oct. 4, 2012 /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, said today it has received clearance to market its new Visions® PV .035 Digital IVUS Catheter in both the US and Europe. The new intravascular ultrasound catheter is designed to image large vessels and facilitate the use of less iodinated contrast in endovascular procedures.
Intravascular ultrasound imaging (IVUS) of diseased arteries and veins allows physicians to observe vessel morphology and make real-time measurements that impact treatment strategies and ultimately patient outcomes. The Visions PV .035 catheter incorporates new centimeter markers to facilitate length measurements important for selecting treatment devices.
"Endovascular repair is preferred over open surgical repair by many patients because of its less invasive nature, shorter recovery times and lower complication rates for patients with suitable anatomy," said David Sheehan, chief operations officer and intravascular imaging business unit leader. "However, precise device sizing and placement is critical for positive outcomes1. Volcano believes IVUS can play an important role in guiding endovascular and other peripheral therapies. The development of this new catheter is just one example of our advancing commitment to this area.
"Another challenge in endovascular repair is renal insufficient patients," he added. "These patients are susceptible to acute kidney injury a condition associated with high cost, morbidity, and mortality due to intraoperative use of iodinated contrast. Using our Visions PV .035 catheter with new centimeter markers reduces the amount of contrast needed, thus minimizing risk1 and creating more options for these patients."
Scott Huennekens, president and chief executive officer added, "Our share leadership in worldwide intravascular and peripheral imaging is because we innovate products that are clinically relevant and improve outcomes for our physicians. Moreover, we continue to add new and improved peripheral products that all work on our existing multimodality platform."
Company officials point to a study conducted in Osaka, Japan, published in the European Journal of Vascular and Endovascular Surgery that demonstrated the use of IVUS resulted in significantly less contrast needed during endovascular aortic repair (EVAR). The new centimeter markers make these procedures faster and easier1 and eliminate the need for additional marker catheters or a sterile ruler.
The new catheter features other enhancements, including a longer connector length to improve procedural flexibility, new materials, a softer, more rounded tip with lower entry profile and GlyDx® hydrophilic coating for delivery through tortuous anatomy. Those interested can see the new Visions® PV .035 Digital IVUS Catheter at the Volcano booth, #500, at the 2012 VIVA conference, October 9-12 in the Wynn Las Vegas hotel in Las Vegas, Nevada.
1 Data on file.
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. Its 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.
SOURCE Volcano Corporation