US FDA Provides 510(k) Approval to Roxwood’s CenterCross Catheter

California based Roxwood Medical Inc. has reported FDA approval for the US commercialization of its CenterCross Catheter for use in the coronary and peripheral vasculature. The CenterCross Catheter extends Roxwood Medical’s product offerings that previously include the FDA-approved MultiCross Catheter platform for assisting physicians tackle obstructions in their patients’ arteries.

The CenterCross Catheter is developed to be applied in association with guidewires and microcatheters to access discrete areas of the coronary and peripheral vasculature and allow physicians to better target wire-crossing of complicated lesions. The catheter incorporates a special self-expanding scaffold to strengthen off-the-shelf interventional tools, like as guidewires and microcatheters, in the center of the artery close to the target lesion.

Initial cases were conducted by some of the major interventional cardiologists throughout the US, like as Dr. Jihad Mustapha of Metro Heart Hospital, Wyoming, Mich., for peripheral situations and Dr. Emmanuoil Brilakis at the Veteran’s Administration Hospital, Dallas, for coronary situations.

“My primary cases with the CenterCross Catheter were outstanding and reliable with my previous experience with MultiCross,” stated Dr. Mustapha. “The CenterCross device monitored perfectly via torturous anatomy and provides a amazing level of assistance, enabling me to cross tough lesions more successfully. These seem to be the most complicated and time-consuming processes, so I’m truly enthusiastic about the advantages CenterCross provide to simplify and shorten these cases, particularly for sufferers dealing with Critical Limb Ischemia.”

“CenterCross provides an interesting new platform to deal with some of the most complicated cases we deal with in treating condition in the coronaries,” included Dr. Brilakis. “It offers outstanding support and centering of my coronary support catheter to enable for luminal guidewire crossing. This is important for sufferers who require coronary revascularization, but usually have restricted treatment choices.”

CEO and President of  Roxwood Medical,  Mehrdad Farhangnia, included: “We’re excited with the initial reception that our CenterCross Catheter is getting clinically. The approval by the FDA of our 2nd product shows an significant milestone for the organization and enables us to work with a wide group of interventionalists throughout the country. In add-on to CenterCross and MultiCross, we have a solid pipeline of new products in our portfolio and expect to ongoing to offer doctors a range of tools to assist them more quickly address their daily clinical requirements.”