Technology | October 19, 2012

Volcano Gains FDA and CE Mark Clearance for New Digital IVUS Catheter

New patent-pending design continues commitment to treating peripheral vascular disease

October 19, 2012 — Volcano Corp., a developer and manufacturer of precision-guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced it has received both U.S. Food and Drug Administration (FDA) clearance and CE mark to market its new Visions PV .035 digital IVUS catheter in both the United States and Europe. The new IVUS (intravascular ultrasound) catheter is designed to image large vessels and facilitate the use of less iodinated contrast in endovascular procedures.

IVUS imaging 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 for Volcano. "However, precise device sizing and placement is critical for positive outcomes. 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 risk and creating more options for these patients."

Scott Huennekens, president and CEO, 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 easier 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.

For more information: www.volcanocorp.com

Related Content

Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major
TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.