Medical device company Roxwood Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its CenterCross Catheter for use in the coronary and peripheral vasculature.
According to the company, the new catheter has been developed for use in conjunction with guidewires and microcatheters to access discrete regions of the coronary and peripheral vasculature and allow clinicians to better address wire-crossing of complex lesions.
The catheter integrates 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.
Roxwood Medical president and CEO Mehrdad Farhangnia said: "The clearance by the FDA of our second product represents an important milestone for the company and allows us to work with a broad group of interventionalists across the country.
"In addition to CenterCross and MultiCross, we have a robust pipeline of new products in our portfolio and look forward to continuing to provide physicians an array of tools to help them more easily address their daily clinical needs."
Roxwood noted that initial cases with the catheter were performed by some of the leading interventional cardiologists across the US, including Dr Jihad Mustapha of Metro Heart Hospital of Wyoming, for peripheral cases and Dr Emmanuoil Brilakis at the Veteran’s Administration Hospital, Dallas, for coronary cases.
The CenterCross Catheter joins the firm’s already existing FDA-cleared MultiCross Catheter platform, which allows clinicians to deal blockages in their patients’ arteries.