Roxwood Medical Introduces FDA-Cleared CenterCross Catheter

December 19, 2014—Roxwood Medical Inc. announced the launch of the CenterCross catheter, which has been cleared by the US Food and Drug Administration (FDA) for use in the coronary and peripheral vasculature. With commercialization in the United States, the CenterCross catheter joins Roxwood Medical’s currently available portfolio of products that includes the MultiCross catheter platform for treatment of blockages in arteries.

According to the company, the CenterCross catheter is designed to be used in conjunction with guidewires and microcatheters to access discrete regions of the coronary and peripheral vasculature and to enable clinicians to better address wire crossing of complex lesions. The catheter incorporates a self-expanding scaffold to stabilize off-the-shelf interventional tools, such as guidewires and microcatheters, in the center of the artery near the target lesion.

Leading interventional cardiologists across the United States performed initial cases with the device, including J. A. Mustapha, MD, of Metro Heart Hospital in Wyoming, Michigan, for peripheral cases and Emmanouil Brilakis, MD, of the Veteran’s Administration Hospital in Dallas, Texas, for coronary cases.

In Roxwood Medical’s press release, Dr. Mustapha commented, “My initial cases with the CenterCross catheter were impressive and consistent with my prior experience with MultiCross. The CenterCross device tracked nicely through tortuous anatomy and offers a surprising level of support, allowing me to cross tough lesions more effectively. These tend to be the most challenging and time-consuming procedures, so I’m really excited about the benefits CenterCross offers to simplify and shorten these cases, especially for patients dealing with critical limb ischemia.”

Dr. Brilakis added, “CenterCross offers an exciting new platform to tackle some of the most complex cases we face in treating disease in the coronaries. It provides excellent support and centering of my coronary support catheter to allow for luminal guidewire crossing. This is significant for patients who need coronary revascularization, but often have limited treatment options.”