A Medical Device Daily
Advanced Circulatory Systems (Minneapolis) said it has received an additional $1.5 million in funding from the National Institutes of Health to continue a study testing two devices used in combination on those who experience cardiac arrest outside a hospital.
According to Advanced Circulatory Systems, the study is necessary because of the dismally low survival rates for cardiac arrest; the national average for surviving such a cardiac arrest that occurs outside a hospital setting is only one in 20.
The NIH funding will be used to increase enrollment in the six-site study. The study involves the testing of the ResQPump an active compression/decompression device, in combination with the ResQPOD, a device used to increase blood flow to the heart and brain during CPR. The ResQPOD, an impedance threshold device proven to increase circulation, has previously received clearance from the FDA and is in use at more than 1,100 customer sites in the U.S. The current NIH-funded study is the first randomized study in the U.S. to assess results of the ResQPump and ResQPOD used together and comparing results when CPR is performed without these devices, the company said. The ResQPump has been tested and is in use in Europe.
The six sites involved in the study include Minneapolis and St. Paul, Minnesota; Whatcom County, Wyoming; Oshkosh, Wisconsin; suburban Detroit including parts of Oakland and Macomb counties, Michigan; and Livingston County, Michigan, which includes the city of Ann Arbor.
The generally cleared indication for the ResQPOD is a temporary increase in blood circulation during emergency care, hospital, clinic and home use. Studies are ongoing in the U.S. to evaluate the long-term benefit of the ResQPOD for indications related to patients suffering from cardiac arrest, hypotension during dialysis and severe blood loss.