Cardionovum® Announces ANVISA Approval of Aperto® OTW DCB for Brazilian Market

Cardionovum® is proud to announce a major milestone: For the approval by ANVISA, the Brazilian Health Regulatory Agency, of Aperto® OTW DCB for commercial use in Brazil. This approval enables Brazilian patients undergoing dialysis to benefit from a therapy that extends the lifespan of their arteriovenous fistulas, thereby improving both quality of life and treatment outcomes.

With The introduction of the Aperto® DCB Cardionovum® brings  its unique SAFEPAX coating technology to Brazil. Supported by extensive and well-established scientific evidence, Aperto® DCB has already transformed treatment outcomes for thousands of patients worldwide.

"At Cardionovum®, we are committed to advancing innovative therapies that make a real difference for patients," said Miquel Craven-Bartle Capella, CEO of Cardionovum® GmbH. "The approval of Aperto® DCB by ANVISA is not only a significant achievement for our company but, most importantly, a meaningful step forward for dialysis patients in Brazil, who will now have access to a therapy that prolongs vascular access survival and enhances their quality of life."

ABOUT CARDIONOVUM®

Cardionovum® is a German medical device manufacturer specializing in the development and commercialization of innovative cardiovascular and peripheral artery therapies, including next-generation drug-coated balloons and drug-eluting stents. The company’s mission is to translate scientific innovation into the highest quality clinically breakthrough medical devices that improve patient outcomes and quality of life.