An Implantable Peritoneal Ultrafiltration Device that actively and continuously prevents fluid overload in congestive heart failure patients

Informations projet

IPUD

N° de convention de subvention: 874316

DOI

10.3030/874316

Projet clôturé

Date de signature de la CE 30 Juillet 2019

Date de début 1 Août 2019

Date de fin 31 Juillet 2022

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 2 957 025,48

Contribution de l’UE

€ 2 036 849,50

Coordonné par

PARAGATE MEDICAL LTD
Israel

Periodic Reporting for period 2 - IPUD (An Implantable Peritoneal Ultrafiltration Device that actively and continuously prevents fluid overload in congestive heart failure patients)

Période du rapport: 2020-09-01 au 2022-07-31

Résumé du contexte et des objectifs généraux du projet

About 26 million people in the world suffer Congestive Heart Failure (CHF), and nearly 4.3 million of them are affected by chronic fluid overload and diuretic resistance. Fluid overloaded patients are coping life of misery and often feel like “breathing an ocean”. If not effectively treated, fluid congestion rapidly leads to premature death. Where for these patients’ oral diuretics fail to perform, the developed clinical symptoms such as dyspnea, tiredness and fatigue lead to a reduced activity and social life, along the burden of being the “frequent flyers” of the hospital. In fact, such patients need frequent hospitalizations for acute fluid diuresis through aggressive treatments such as ultrafiltration and dialysis – all associated with complication and high economic burden on healthcare systems. Most importantly, current solutions fail to prevent recurrence of fluid congestion.
Paragate has developed a unique Implantable Peritoneal Ultrafiltration Device (IPUD) to improve the quality of life and health of diuretic resistant CHF patients. IPUD is a minimally invasive and fully implantable device, serving as a mechanical bypass to the kidneys, that monitors fluid overload and prevents fluid congestion by actively, continuously and non-aggressively remove excess fluid from the body, to keep patients balanced at home.
Foreseen objectives of the proposed project include miniaturization of the implantable system; optimization of system performance; upgrade of the treatment management platform to improve robustness and usability; and clinical validation to demonstrate safety and efficacy of the system to pursue CE Marking.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

Within the project, we have been actively working on the system optimization and miniaturization to ensure that drainage functionality and battery performed met the standards required to proceed towards clinical validation. We also upgraded the treatment management platform to improve its robustness and usability. Verification and Validation testing and animal testing are underway, and we are preparing for obtaining Ethics Committee approval for the foreseen clinical trial. Paragate technology and project results is continuing to receive acknowledgement, and recent exposure in events has brought further interest from the community and Key Opinion Leaders.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

We aim to demonstrate safety and efficacy of our IPUD system in a clinical trial in selected hospitals across Europe, and obtain the clinical evidence needed to obtain CE Mark. The SME Instrument Phase II project will enhance the future launch of the IPUD into the European marketplace and provide a unique solution for the multi-billion societal and economic burden of fluid overload in Congestive Heart Failure. With IPUD, the weight of care will be shifted from frequent, repeated hospital admissions to active, continuous home-based care.

Purpose of Paragate's at-home treatment