Vivance has recently announced that the next trial phase of the wearable peritoneal dialysis (PD) device, Viva Kompact, has successfully concluded. The study was conducted at Singapore General Hospital, and was shared at the American Society of Nephrology (ASN) Kidney Week (23–27 October, San Diego, USA).
Viva Kompact received US Food and Drug Administration (FDA)’s breakthrough device designation in 2019, following the completion of the first-in-human clinical trial. Earlier this year, the pre-pivotal trial was completed, focusing on evaluating the device’s performance and safety parameters while being independently used by patients in their home environment.
“Completing this trial is a momentous achievement for our team, patients and healthcare professionals who are equally passionate about advancing kidney care to the next level,” said Suresha Venkataraya, chief executive officer of Vivance. “We are excited to share our findings, which we believe will contribute significantly to advancing the possibility of dialysis anytime, anywhere.”
The trial results were presented during oral sessions at Kidney Week by Marjorie Foo (Singapore General Hospital, Singapore), the principal investigator, who said: “I am excited to share the findings from this first-of-a-kind wearable dialysis device which underwent a trial at Singapore General Hospital. 10 patients were able to independently use the device and successfully complete at least one week of dialysis at their homes, with no device-related serious adverse events.”
Mandar Gori, chief business officer of Vivance, said: “We thank all collaborators, especially our clinical advisors, who made the pre-pivotal trial of this US FDA-designated breakthrough device possible.”
