Cardiovascular Systems, Inc. has announced the first patient enrollment in its prospective, randomized CALCIUM 360 degree clinical trial, part of the company’s 360 degree Clinical Series. The CALCIUM 360 degree study will evaluate the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI’s Diamondback 360^® PAD System, a minimally invasive catheter for treating PAD anywhere in the leg.

Onset Medical Corporation has announced that it has received U.S. FDA 510(k) marketing clearance for the Company’s SoloPath™ TransFemoral Endovascular Access Catheter. These catheters are designed to provide access to diseased arteries at a relatively small catheter size and then be expanded to provide a conduit for the delivery of larger diameter devices. Another clinical market for the SoloPath Catheter is in the delivery of stent grafts for the treating aortic aneurysms.

Vascular Solutions, Inc. has announced that it has received 510(k) clearance from the U.S. Food & Drug Administration to launch the GuideLiner(TM) catheter. The GuideLiner is a unique coaxial “mother and child” guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions’ specialty catheter product line.

Biosense Webster, Inc. has announced that FDA has cleared for marketing the CARTO® 3 System, the most advanced three-dimensional imaging technology for use by electrophysiologists in treating cardiac arrhythmias, commonly referred to as irregular heart rhythms. Atrial Fibrillation, or AFib as it`s more commonly known, is the most prevalent cardiac arrhythmia affecting between 2.3 to 5.6 million adults in the country and is the leading cause of stroke among people 65 years and older.