Roxwood announces 510(k) and US commercial launch of the CenterCross catheter


Roxwood Medical has announced FDA clearance for the US commercialisation of its CenterCross catheter for use in the coronary and peripheral vasculature.

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

Initial cases were performed by some of the leading interventional cardiologists across the USA, including Jihad Mustapha of Metro Heart Hospital, Wyoming, for peripheral cases and Emmanuoil Brilakis at the Veteran’s Administration Hospital, Dallas, for coronary cases.

“The CenterCross device tracked nicely through torturous 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,” says Mustapha.

Brilakis adds: “It provides excellent support and centring of my coronary support catheter to allow for luminal guidewire crossing. This is significant for patients who need coronary revascularisation, but often have limited treatment options.”