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

Volcano Corporation 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.

CoreValve®: High Risk Patient Study Enrollment Complete, FDA Says Yes To Start Intermediate Risk Patient Study

Medtronic, Inc. is announcing twin milestones for its CoreValve® clinical program on the long road to U.S. approval. First, it completed enrollment in its study of high risk patients in its U.S. Pivotal Trial, and then FDA gave it the nod to start a global trial in intermediate patients.

How Can Stryker’s Wingspan Neuro Stent Maintain Broad CE Mark In Europe When U.S Study Results Have Driven FDA To Restrict It’s Use?

The consequences of our distinct regulatory set-ups is that sometimes study information that drives indications for use one side of the pond is ignored on the other, despite the fact that it may have significant clinical consequences as seems to be the case with Stryker’s Wingspan Neurovascular Stent.

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