Vivance Concludes Successful Pre-Pivotal Trial
Vivance, a pioneering force in kidney care innovations, has proudly announced the successful conclusion of the next trial phase for its groundbreaking wearable peritoneal dialysis (PD) device, known as Viva Kompact. Conducted at a prominent healthcare facility, this trial represents a significant milestone in the mission to improve kidney care.
Key Achievements of the Viva Kompact Trial
The pre-pivotal trial was designed to evaluate the performance and safety of the Viva Kompact device when used independently by patients in the comfort of their own homes. This innovative device received a breakthrough designation from the US Food and Drug Administration (FDA) in 2019, indicating its potential to change the landscape of kidney treatment positively.
Patient-Centric Results from the Trial
Suresha Venkataraya, the CEO of Vivance, expressed tremendous pride in the accomplishment. He stated, "Completing this trial is a momentous achievement for our team, patients, and healthcare professionals dedicated to advancing kidney care. We are eager to share our findings which we believe will significantly enhance dialysis accessibility for patients."
One of the standout features of the Viva Kompact trial is its focus on real-world application. Ten patients were able to successfully use the device independently for at least one week, marking a considerable achievement without any serious device-related adverse events. This data is crucial for understanding how patients adapt to and benefit from the technology in their daily lives.
Upcoming Presentation at ASN Kidney Week
A/Prof. Marjorie Foo, the Principal Investigator from the Department of Renal Medicine, will present the trial results during oral sessions at the American Society of Nephrology (ASN) Kidney Week. This prestigious event provides an excellent platform for sharing innovative findings with professionals dedicated to improving kidney health.
What to Expect from the Presentation
The presentation is set to delve into critical facets such as the efficacy of the Viva Kompact device, patient experiences, and overall performance data. Insights gained from this trial can profoundly impact future developments in home dialysis technology.
Collaboration and Support for Advanced Kidney Care
Mandar Gori, Chief Business Officer of Vivance, highlighted the collaborative effort involved in making this FDA-designated breakthrough device trial a reality. He expressed gratitude towards clinical advisors and collaborators who played vital roles in advancing kidney care technology.
Attendees of ASN Kidney Week will have the opportunity to learn more about the Viva Kompact device and explore additional innovations at Vivance's booth, enhancing engagement within the kidney care community. This exposure is essential for encouraging discussion about new technologies that will redefine patient care.
About Vivance
Vivance, formerly known as AWAK Technologies, is dedicated to enhancing the lives of individuals living with kidney disease. The company’s mission revolves around providing innovative solutions that aim to improve patient outcomes and life quality.
Headquartered in Singapore, Vivance also operates in locations across the globe, including Los Angeles and Bengaluru. Its commitment to research and development is unwavering as it seeks to introduce novel technologies in kidney care.
For more information about their groundbreaking work and solutions in kidney care, visit their official website.
Frequently Asked Questions
What is the Viva Kompact device?
The Viva Kompact is a wearable peritoneal dialysis device designed to provide patients with greater flexibility and independence in their kidney care treatment.
When will the trial results be shared?
The results from the pre-pivotal trial will be presented during the ASN Kidney Week, which is set to occur from October 23-27.
What were the main findings of the trial?
The trial demonstrated that patients could use the device independently for at least one week without serious adverse events, showcasing its potential for home use.
Who is presenting the trial results?
A/Prof. Marjorie Foo, Principal Investigator, will present the findings focusing on device performance and patient experience.
What is Vivance’s mission?
Vivance aims to enhance the quality of life for patients with kidney disease by developing innovative solutions tailored to their needs.
