New Visions PV .035 Digital IVUS Catheter gets FDA clearance and CE mark approval

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Volcano has announced it has received FDA clearance and the CE mark to market its new Visions PV .035 Digital IVUS Catheter in both the USA 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 centimetre 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 outcomes. Volcano believes IVUS can play an important role in guiding endovascular and other peripheral therapies.”


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 centimetre 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.