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An innovative implantable device and management platform to prevent chronic fluid congestion

Periodic Reporting for period 1 - FILBERT (An innovative implantable device and management platform to prevent chronic fluid congestion)

Período documentado: 2023-08-01 hasta 2024-07-31

Congestive Heart Failure (CHF) is a progressive disease affecting ~28 M people in the world. Fluid overload is a main clinical complication of CHF and the primary driver of CHF-related morbidity and hospitalization (>1M hospitalizations in Europe each year). CHF can affect the normal kidney functioning, hampering its ability to excrete sodium from the body. This causes sodium levels to increase; to restore the balance, the body retains water, leading to fluid accumulation across the body (arms, legs, lungs, abdomen). CHF patients live a poor-quality life, distressed by shortness of breath, fatigue, difficulty exercising and swelling of the limbs. Fluid overload increases the burden on the weakened heart, further exacerbating the problem. If not effectively treated, fluid congestion rapidly leads to premature death (median survival is 1.5 years after second readmission with poor kidney function due to cardiorenal syndrome).
Paragate Medical aims to improve the clinical condition of fluid overloaded patients by continuously removing extracellular fluids through FILBERT: our patented, unique implantable peritoneal ultrafiltration device, operating non-aggressively and independently of the kidneys’ function to prevent fluid accumulation in the CHF patient’s body. FILBERT will provide the first effective 24/7 fluid removal solution, preventing fluid accumulation and eliminating the need for hospital admissions.
FILBERT will improve the quality of life of CHF patients through an effective monitoring and gentle treatment solution that delivers fully personalized care. Continuous fluid removal will further improve patient’s clinical conditions, reducing anxiety and enabling patients a faster return to their daily lives. The comprehensive monitoring, will also inform better therapeutic decisions and delay disease complications leading to kidney failure.
In the first months of the project implementation, we performed the following activities:
Under WP2, we were granted a new US patent, we filed one divisional patent and one new PCT application. One additional provisional patent application was also filed.
Under WP3 we started the collection of clinical samples (24 samples collected and tested in vitro) with 2 sites, we had our new implant generation optimised and the new percutaneous procedure developed (now under testing). Finally, we have progressed with the active system miniaturisation activities (ongoing).
Under WP4 we started early biocompatibility long term implantation testing and new process materials cytotoxicity verification with successful results.
Remote patient care has become a frequent figure of speech in the post-COVID era with clear understanding of the potential impact on healthcare system. FILBERT system has can make the giant leap in remote care by introducing an active system, with remote therapeutic capabilities that goes way beyond the monitoring.
In the long run, FILBERT has the potential to become the future gold standard device for fluid overload management. In the short term, FILBERT has the potential to improve the quality of life of millions of CHF patients dealing with fluid congestion every day.
This will have an enormous impact on the current market dynamics, dominated by a few key players with established brands, of which only none is offering a commercial product directly targeting volume reduction. FILBERT has the unique opportunity to strengthen Europe's sovereignty within the CHF industry, as Paragate may become the leading global provider of extracellular fluid drainage therapy in any clinical application where this is required.
Filbert device
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