Clinical Accelerator, a full-service contract research organization with a strong focus on medical device investigations, is pleased to report that despite the global disruption caused by Covid-19, work has been continued in the Republic of Georgia on RED DESERT – Repeated Dose alfapump DSR study for Treatment of diuretic-resistant heart failure patients. The study is sponsored by Sequana Medical, an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure.
Sequana Medical was founded in 2006 with the initial aim of finding a better way to manage ascites patients. The company has developed and commercialised the alfapump in Europe, a fully implantable, programmable, wirelessly-charged, battery-powered system that is CE-marked for the treatment of refractory ascites due to liver cirrhosis and malignant ascites. In the U.S., the alfapump received Breakthrough Device designation for recurrent or refractory ascites due to liver cirrhosis and Sequana Medical is currently running the North American pivotal POSEIDON study to support FDA approval. Over 750 alfapump systems have been implanted to date.
The company is now extending the application of its unique technology to a new indication – management of volume overload in heart failure patients. The new device is called alfapump DSR (Direct Sodium Removal). This innovative therapy is being developed in collaboration with Dr Jeffrey Testani, Associate Professor at Yale University. The results of the FIH single dose DSR study, conducted by Dr Testani were presented at the Heart Failure 2019 Congress and published in Circulation.
Sequana Medical’s alfapump DSR system involves the use of the peritoneal cavity for the removal of excess sodium via diffusion. The system comprises of i) the alfapump a fully implanted subcutaneous device with a rechargeable battery that moves fluid from the peritoneal cavity to the urinary bladder where it is eliminated and ii) an implantable peritoneal catheter port. The DSR System is used in conjunction with the DSR infusate (zero sodium peritoneal solution, 10% dextrose in sterile water), which is instilled into the peritoneal cavity and left to dwell for a period of 2 hours.
The ongoing study is a prospective, single-arm, repeated dose study and is expected to include up to 10 heart failure patients, who are on high dose diuretics, across two centres in Belgium and Georgia. The primary safety endpoints include the rate of device, procedure and/or therapy-related serious adverse events after two and six weeks. The secondary endpoints include the feasibility of alfapump DSR to remove excess sodium and fluid from the body, thereby eliminating the need for daily high dose diuretics during the six-week treatment period. Additional exploratory endpoints to measure the potential impact of DSR therapy to restore response to diuretics will be evaluated through week six.
About Sequana Medical
Sequana Medical is a commercial stage medical device company developing the alfapump platform for the management of fluid overload in liver disease, malignant ascites and heart failure. Fluid overload is a fast-growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfapump DSR (Direct Sodium Removal) is estimated to be over €5 billon annually in the U.S. and EU5 by 2026. Both indications leverage Sequana Medical’s alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
Important Regulatory Disclaimers
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.poseidon.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.
About Clinical Accelerator
Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization was founded by a heart failure cardiologist and performs many clinical investigations of cardiovascular medical devices, with a special focus on heart failure. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.