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Roxwood Medical announces FDA 510(k) clearance andUS commercial launch of its CenterCross Catheter

Inc. has announced FDA clearance for the US commercialization of its Catheter for use in the coronary and . The Catheter expands Roxwood Medical’s product offerings that already includes the FDA-cleared MultiCross Catheter platform for helping clinicians tackle blockages in their patients’ arteries.

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 enable clinicians to better address wire-crossing of complex lesions. The catheter incorporates a unique 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.

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

“My initial cases with the CenterCross Catheter were impressive and consistent with my prior experience with MultiCross,” said Dr. Mustapha. “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.”

“CenterCross offers an exciting new platform to tackle some of the most complex cases we face in treating disease in the coronaries,” added Dr. Brilakis. “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.”

Roxwood Medical President and CEO, Mehrdad Farhangnia, added: “We’re thrilled with the initial reception that our CenterCross Catheter is receiving clinically. 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.”


Source: Roxwood Medical Inc.