The Brazilian Health Regulatory Agency (ANVISA) recently approved Cardionovum‘s Aperto over-the-wire (OTW) drug-coated balloon (DCB) for commercial use in Brazil, a press release has revealed.
Cardionovum shares that 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, the press release reads, Cardionovum brings its Safepax coating technology to Brazil. The company notes that the Aperto DCB is supported by extensive and well-established scientific evidence and 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, chief executive officer of Cardionovum. “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.”
