CE Mark and 510(k) Clearance for New Visions PV .035 Digital IVUS Catheter

Volcano Corporation 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, 2012, in the Wynn Las Vegas hotel in Las Vegas, NV.

^₁ Data on file