Project description
A novel implantable filtration device will help restore fluid balance safely and effectively
About 60 % of your body is water, within and surrounding all cells. Maintaining the balance is required for normal functioning of tissues and organs. Hypervolemia, in which the extracellular fluid (ECF) volume expands due to retention of sodium and water, is common in patients with congestive heart failure. Some patients do not respond to diuretics and mechanical removal of excess fluid is currently complicated. IPUD has developed an efficient implantable filtration device that can remove excess ECF at the rate of one litre per day and drain it via the urinary system. An embedded sensing system monitors both the fluid and urinary system function. With EU support, the device is now headed to pre-clinical and clinical trials.
Objective
Pathologic fluid overload (congestion) is a medical condition when high volume of fluid (water) accumulates in the body
leading to congestive heart failure (CHF). CHF is a severe global health problem affecting each year ~26 million people
worldwide, of which 8 million are chronic and diuretic resistant patients. Current solutions for fluid overload in diuretic
resistant patients such as infusion pump for intravenous (IV) diuresis, catheter-based device for ultrafiltration therapy and
peritoneal dialysis all carry complications and are acute treatments which do not prevent recurrence.
Paragate developed IPUD a unique implantable peritoneal ultrafiltration system for continuous monitoring and removal of
extracellular fluids in CHF patients. It is minimally invasive (laparoscopic approach) and continuously (24/7)
and slowly absorbs systemic isotonic extracellular fluid and drains it to the urinary system preventing recurred accumulation.
In addition, IPUD guarantees a continuous monitoring of the fluid as well as the urinary system function thanks to a sensing
system (embedded into the implantable system) and a treatment management platform. In this way, physicians have a direct
control of the treatment and patient’s condition.
The controlled, moderate non-aggressive fluid removal eliminates the main complications associated with the acute and
aggressive treatments that lead to hemodynamic shock, worsening of renal function, arrhythmia and metabolic instability.
Thanks to IPUD, patients will improve their quality of life eliminating frequent hospitalizations with a more effective treatment
and healthcare systems will significantly reduce the €100 billion/year cost for frequent hospitalizations and treatment costs.
The Phase 2 project will enable Paragate to scale-up production, perform validation and verification activities including a
preclinical study; and validate the safety and efficacy of IPUD in a pilot clinical trial.
Fields of science
Keywords
Programme(s)
Funding Scheme
SME - SME instrumentCoordinator
Nazareth
Israel
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.