Disclaimer
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.
Sequana Medical has leveraged its alfapump® experience and is developing alfapump® DSR, a fully implanted system for DSR therapy in patients with volume overload due to heart failure.
alfapump® DSR combines three proven elements:
The sodium-free infusate is administered to the peritoneal cavity via the surgically implanted port, which allows for flexible dosing to remove the desired amount of sodium. The DSR infusate remains there for a pre-determined period of time before the DSR infusate and the extracted sodium is pumped to the bladder and eliminated through urination.
A repeated dose alfapump® DSR study, combining DSR therapy with our proven alfapump® platform, began in H2 2019.
Estes et al. (2018)
Estes et al. (2018)
Estes et al. (2018)
Estes et al. (2018)
The alfapump® fait toujours l’objet d’une étude clinique aux États-Unis et au Canada. Par conséquent, aucun énoncé concernant la sécurité et l’efficacité ne s’applique dans ces territoires.
Le traitement DSR est encore en développement et il convient de noter que toute déclaration concernant la sécurité et l’efficacité découle d’investigations précliniques et cliniques en cours qui n’ont pas encore été complétées.
Il n’y a pas de lien entre le traitement DSR et les investigations en cours avec le système alfapump® en Europe, aux États-Unis et au Canada.
De alfapump® is nog steeds in klinisch onderzoek in de VS en Canada en daarom zijn alle uitspraken met betrekking tot veiligheid en werkzaamheid niet van toepassing in deze gebieden.
De DSR-therapie is nog in ontwikkeling en het moet worden opgemerkt dat alle uitspraken met betrekking tot veiligheid en werkzaamheid voortkomen uit lopend preklinisch en klinisch onderzoek dat nog moet worden voltooid.
Er is geen verband tussen de DSR-therapie en lopende onderzoeken met het alfapump® systeem in Europa, de VS en Canada.
U.S. Centers for Disease Control and Prevention, Health, United States 2016, Chartbook on Long-term trends in Health, Table 20 (website)
Ginès et al. (2004) (verklarende dat refractaire ascites zich voordoet bij 5 tot 10 procent van de patiënten met ascites)
Testani JM, Hanberg JS, Cheng S, et al. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Circulation Heart failure. 2016;9(1):e002370. doi:10.1161/CIRCHEARTFAILURE.115.002370.
Kilgore et al. (2017); Ambrosy et al. (2014)
Kilgore et al. (2017)
Costanzo et al. (2007)
Benjamin et al. (2013)
Ayantunde et al. (2006)
Wereldgezondheidsorganisatie Internationaal Agentschap voor Kankeronderzoek 2018 (http://gco.iarc.fr/today/home) (geschat aantal nieuwe borst- en eierstokkankers in 2018 (bruto cijfer))
Europese Vereniging voor Leveronderzoek EASL richtlijnen klinische praktijk voor het beheer van ascites, spontane bacteriële buikvliesontsteking en hepatorenaal syndroom bij cirrose. Journel of Hepatology. 2010 vol. 53. 397-417. p. 402.
Runyon et al. (2009)
GlobalData NASH Epidemiology Forecast to 2026
U.S. Centers for Disease Control and Prevention, Health, United States 2016, Chartbook über Langzeit-Trends im Gesundheitswesen, Tabelle 20 (web site)
GlobalData NASH Epidemiologie-Prognose bis 2026.
Runyon et al. (2009)
Ginès et al. (2004) (mit Angabe, dass refraktärer Aszites bei 5 bis 10 Prozent der Patienten mit Aszites auftritt).
European Association for the Study of the Liver. EASL klinische Richtlinien für die Behandlung von Aszites, spontane bakterielle Peritonitis und hepatorenales Syndrom bei Zirrhose. Journel of Hepatology. 2010 Bd. 53. 397-417. S. 402.
World Health Organization Internationale Agentur für Krebsforschung 2018 (http://gco.iarc.fr/today/home) (geschätzte Anzahl neuer Brust- und Ovarialfälle in 2018 (Bruttoziffer))
Ayantunde et al. (2006)
Benjamin et al. (2013)
Costanzo et al. (2007)
Costanzo et al. (2007)
Kilgore et al. (2017); Ambrosy et al. (2014)
Testani JM, Hanberg JS, Cheng S, et al. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Circulation Heart failure. 2016;9(1):e002370. doi:10.1161/CIRCHEARTFAILURE.115.002370.
In den USA und Kanada befindet sich der alfapump® derzeit noch in der klinischen Erprobung. Daher sind Aussagen zur Sicherheit und Wirksamkeit in diesen Gebieten nicht anwendbar.
Die DSR-Therapie befindet sich noch in der Entwicklung, und es sollte beachtet werden, dass Aussagen zur Sicherheit und Wirksamkeit aus laufenden vorklinischen und klinischen Untersuchungen stammen, die noch nicht abgeschlossen sind.
Es besteht kein Zusammenhang zwischen der DSR-Therapie und laufenden Untersuchungen mit dem alfapump®-System in Europa, den USA und Kanada.
Ginès et al. (2004) (déclarant que l’ascite réfractaire apparaît chez 5 à 10% des patients souffrant d’ascite)
The alfapump® is still under clinical investigation in the US and Canada and therefore any statements regarding safety and efficacy do not apply in these territories.
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.
There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe, the US and Canada.
Testani JM, Hanberg JS, Cheng S, et al. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Informations sur la défaillance cardiaque. 2016;9(1):e002370. doi:10.1161/CIRCHEARTFAILURE.115.002370
Kilgore et al. (2017); Ambrosy et al. (2014)
Kilgore et al. (2017)
Costanzo et al. (2007)
Benjamin et al. (2013)
Ayantunde et al. (2006)
Organisation Mondiale de la Santé Agence Internationale pour la Recherche sur le Cancer 2018 (Visitez le site Internet) (nombre estimé de nouveaux cas de cancer de l’ovaire en 2018 (taux brut))
Association Européenne de l’Étude du Foie. EASL directives de pratique clinique relatives à la gestion d’ascites, de péritonites bactériennes spontanées et du syndrome hépatorénal dans le cadre d’une cirrhose Journal d’hépatologie. 2010 vol. 53. 397-417. p. 402.
Ginès et al. (2004) (stating refractory ascites occurs in 5 to 10 percent of patients with ascites)
Runyon et al. (2009)
GlobalData NASH Epidemiology Forecast to 2026
U.S. Centers for Disease Control and Prevention, Health, United States 2016, Chartbook on Long-term trends in Health, Table 20 (Visitez le site Internet)
U.S. Centers for Disease Control and Prevention, Health, United States 2016, Chartbook on Long-term trends in Health, Table 20 (web site)
Benjamin et al. (2013)
Ayantunde et al. (2006)
Testani JM, Hanberg JS, Cheng S, et al. Rapid and Highly Accurate Prediction of Poor Loop Diuretic Natriuretic Response in Patients With Heart Failure. Circulation Heart failure. 2016;9(1):e002370. doi:10.1161/CIRCHEARTFAILURE.115.002370
Kilgore et al. (2017); Ambrosy et al. (2014)
Kilgore et al. (2017)
Costanzo et al. (2007)
World Health Organization International Agency for Research on Cancer 2018 (website) (estimated number of new breast and ovarian cases in 2018 (crude rate))
European Association for the Study of the Liver. EASL clinical practice guideliones on the management of ascites, spontane bacterial peritonitis, and hepatorenal syndrome in cirrhosis. Journel of Hepatology. 2010 vol. 53. 397-417. p. 402
Runyon et al. (2009)
GlobalData NASH Epidemiology Forecast to 2026
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