WOONSOCKET, R.I., July 17, 2019 /PRNewswire/ -- CVS Health (NYSE:
CVS) today announced the initiation of a clinical trial designed to
evaluate the safety and efficacy of the HemoCare™ Hemodialysis
System for administration of home hemodialysis. The innovative
device includes safety features and is designed to make home
hemodialysis simple for patients. Home hemodialysis helps
facilitate longer, more frequent dialysis treatments as compared to
in-center treatments, and published clinical research has found
that longer, more frequent hemodialysis treatments result in better
health outcomes in appropriate patient populations.1,2,3
The clinical trial of up to 70 patients will be conducted at up to
ten sites in the United
States.
"We're working now to change the kidney care paradigm by
bringing to market programs and tools to improve early detection of
kidney disease and provide comprehensive education and support to
help delay the transition to dialysis," said Alan Lotvin, M.D., Executive Vice President and
Chief Transformation Officer, CVS Health. "For those patients who
do progress to dialysis, we are working to bring a new solution to
the consumer that addresses the current barriers to and limitations
of existing dialysis options, and we are working closely with the
U.S. Food and Drug Administration as we evaluate this
device."
Currently, hemodialysis, which uses a machine to clean a
patient's blood, is most commonly administered in a dialysis center
three times per week. However, an expanding body of scientific
literature indicates that clinical outcomes for hemodialysis
patients can be improved if treatments are longer in duration,
which can be challenging to achieve via in-center dialysis.
During the trial, investigators will measure the safety and
performance of the HemoCare Hemodialysis System. In the initial
phase of the trial conducted at medical facilities, clinical study
subjects and their caregivers will receive training on the system
and will then transition to home-based dialysis. Primary study
endpoints include adverse events as well as regular tests to
measure the dose efficacy of dialysis delivered by the device. The
HemoCare Hemodialysis System was developed in collaboration with
DEKA Research & Development Corp.
"DEKA designed this device with patients in mind to help make
home dialysis safe and simple," said Dean
Kamen, founder of DEKA Research & Development Corp. "CVS
Health is uniquely positioned to redefine identification, education
and treatment for chronic kidney disease, making them our ideal
partner."
The clinical evaluation of the HemoCare Hemodialysis System and
the early kidney disease identification and stratification
programs are solutions of CVS Kidney Care, a CVS Health
company. CVS Kidney Care is developing a series of comprehensive
solutions for all commercial and government payers that are focused
on improving health and outcomes for people living with chronic
kidney disease (CKD) and end stage renal disease (ESRD).
In addition, CVS Kidney Care aligns with the core objectives of
the recently announced Advancing Kidney Health initiative.
Led by the U.S. Department of Health and Human Services' (HHS), the
new effort aims to help improve early detection of and expand
treatment options for kidney disease while working to reduce
unnecessary health care costs for both patients and payers.
"We have been working to fundamentally disrupt the kidney care
market and rapidly innovate in an area that has stagnated for
decades, and we applaud the administration for taking bold steps
toward advancing kidney care as they are helping to rethink how to
make kidney transplant and home dialysis mainstays of therapy,"
added Dr. Lotvin. "CVS Kidney Care is uniquely positioned to help
deliver on the core tenets of this new HHS initiative in a way that
no one else can, and we look forward to working together to help
transform the kidney treatment experience for millions of
Americans."
More than 37 million Americans have kidney disease, and nearly
700,000 have ESRD. Of those with ESRD, more than 500,000 of
these patients are on active dialysis and more than 120,000 new
ESRD cases are diagnosed each year. Financially, this disease
represents a huge cost burden, costing Medicare $35 billion annually related to dialysis patient
care. Despite this high level of spending, outcomes for dialysis
patients are poor, with one in six dialysis patients
dying4 in the first year after starting
treatment.
Health care providers, patients, caregivers and patient
organizations who want to learn more about the HemoCare
Hemodialysis System clinical trial can reach us at
KidneyCare@CVSHealth.com or learn more at
www.cvshealth.com/kidneycare.
About CVS Health
CVS Health is the nation's premier health innovation company
helping people on their path to better health. Whether in one of
its pharmacies or through its health services and plans, CVS Health
is pioneering a bold new approach to total health by making quality
care more affordable, accessible, simple and seamless. CVS Health
is community-based and locally focused, engaging consumers with the
care they need when and where they need it. The Company has more
than 9,900 retail locations, approximately 1,100 walk-in medical
clinics, a leading pharmacy benefits manager with approximately 94
million plan members, a dedicated senior pharmacy care business
serving more than one million patients per year and expanding
specialty pharmacy services. CVS Health also serves an estimated 38
million people through traditional, voluntary and consumer-directed
health insurance products and related services, including a rapidly
expanding Medicare Advantage offering and a leading standalone
Medicare Part D prescription drug plan. The Company believes its
innovative health care model increases access to quality care,
delivers better health outcomes and lowers overall health care
costs. Find more information about how CVS Health is shaping the
future of health at https://www.cvshealth.com.
Media
Contact:
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Investor
Contact:
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Christina
Beckerman
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Joe
Krocheski
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CVS Health
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CVS Health
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401-770-8868
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860-273-0896
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Christina.Beckerman@CVSHealth.com
|
KrocheskiJ@Aetna.com
|
1 Culleton BF, Walsh M, Klarenbach SW, et al.
Effect of frequent nocturnal hemodialysis vs conventional
hemodialysis on left ventricular mass and quality of life: a
randomized controlled trial. JAMA. 2007;298(11):
1291-1299.
2 Kotanko P, Garg AX, Depner T, et al. Effects of
frequent hemodialysis on blood pressure: Results from the
randomized frequent hemodialysis network trials. Hemodialysis Int.
2015:19(3): 386-401.
3 Nesrallah GE, Lindsay RM, Cuerden MS, et al.
Intensive hemodialysis associates with improved survival compared
with conventional hemodialysis. J Am Soc Nephrol 2012; 23 (4):
696-705.
4 United States Renal Data System. 2018 USRDS annual
data report: Epidemiology of kidney disease in the United States. National Institutes of
Health, National Institute of Diabetes and Digestive and Kidney
Diseases, Bethesda, MD, 2018.
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SOURCE CVS Health