The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com.
The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed.
The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe.
This is a a multi-centre, prospective, single-arm, first-in-human study to evaluate the safety and feasibility of alfapump® DSR. Up to 10 patients diagnosed with stable chronic heart failure on high dose oral diuretics will be implanted with the alfapump® DSR system ( alfapump® and implanted surgical port) across two centres in Belgium and Georgia.
The primary safety endpoints include absence of device, procedure and/or therapy related serious adverse events through day 14 and the rate of device, procedure and/or therapy related serious adverse event through day 42. Secondary feasibility endpoints include the ability of alfapump® DSR to maintain a neutral sodium balance in the absence of diuretic therapy and the sustained effect of DSR to maintain euvolemia through week 6. Additional exploratory endpoints will evaluate the potential impact of DSR to restore response to diuretics following DSR therapy. For more information about the study, please visit clinicaltrials.gov (NCT04116034).
First-in-human single dose DSR proof of concept study to assess safety, tolerability and impact of direct sodium removal therapy in 10 patients receiving peritoneal dialysis (PD). Results selected for late-breaking abstract session at Heart Failure 2019.
Testani et al., Circulation, 2019
Presentation by Dr. Testani at Heart Failure 2019
Webcast by Sequana Medical management and Dr. Testani on 27 May 2019
Single dose, single arm preclinical proof of concept study to assess impact of direct sodium removal therapy in 15 healthy pigs and 5 pigs with experimentally induced heart failure via tamponade.
Poster by Testani et al., HFSA, 2018
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