EDEN PRAIRIE, Minn., July 14, 2020 (GLOBE NEWSWIRE) -- CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to improving the lives of patients suffering from fluid overload, today announced key takeaways from a recent webinar where David Askenazi, M.D. MSPH shared his experience and perspectives on the treatment of fluid overload in pediatric patients weighing more than 20 kg.
Dr. Askenazi is the Director of the Pediatric and Infant Center for Acute Nephrology (PICAN) at Children’s of Alabama, the pediatric hospital affiliated with University of Alabama at Birmingham. Dr. Askenazi is a forerunner in pediatric kidney support therapy and author of dozens of clinical papers on managing fluid balance and providing kidney support in pediatric patients. He has created and hosts the Neonatal and Infant Course on Kidney Support (NICKS) at Children’s of Alabama.
Clinically important observations made by Dr. Askenazi during the webinar include:
- In pediatric patients, fluid overload is a common problem impacting morbidity and mortality, and fluid overload is associated with multiple conditions, such as heart surgery, nephrotic syndrome, congenital heart disease, kidney disease, solid organ and bone marrow transplants, sepsis and severe burns.
- Addressing fluid overload and initiating treatment early optimizes outcomes in pediatric patients; therefore, fluid volume should be reported and monitored as a critical vital sign, similar to other vital signs.
- To assess fluid overload, fluid volume status should be considered in light of the phases of therapy: rescue, optimization, stabilization and de-escalation.
- Treatment options for fluid overload include medical management, fluid restriction and diuretics and ultrafiltration (aquapheresis).
- While a majority of ICU patients receive diuretics to treat fluid overload, multiple studies have shown limited direct improvement in clinical outcomes.1
- Ultrafiltration provides an early alternative therapy to be considered when medical management fails to achieve fluid balance. Repeating traditional therapies may harm the patient.
- Alternative fluid removal therapies include peritoneal dialysis, continuous renal replacement therapy (CRRT), intermittent hemodialysis and ultrafiltration. Each therapy has advantages depending on the condition and treatment goals for the patient.
- Ultrafiltration with the Aquadex system is simple, easy to set up and provides flexibility to address the needs of the patient.
- In a retrospective, multi-center study, 32 critically ill pediatric patients weighing over 20 kgs and predominantly suffering from hypervolemia were treated with the Aquadex FlexFlow System and 97% (31/32) survived to the end of therapy with minimal complications associated with the system.2
“Ultrafiltration is a safe and effective therapy for removing fluid in pediatric patients weighing more than 20 kg,” said Dr. Askenazi. “The therapy is a helpful and complementary fluid management tool offering high benefits at a low risk for patients. Pediatric patients can be very delicate and having a gentle and flexible option on hand can improve the quality of care provided to fluid overloaded children.”
“Since the FDA clearance of the Aquadex SmartFlow for eligible pediatric patients, pediatric hospitals across the country have recognized the benefit of utilizing gentle ultrafiltration in these patients,” said John Erb, CEO of CHF Solutions. “Physicians like Dr. Askenazi are leading the way in creating awareness of life-saving therapies for the treatment of fluid overload in our most fragile patients, and we’ll continue to support educational opportunities that can have a positive impact on patient outcomes.”
The replay of the webinar is available at https://ir.chf-solutions.com/events and https://www.youtube.com/watch?v=sMIF5x5qqvY
About Fluid Overload in Pediatric Patients
Fluid overload (hypervolemia), which occurs when there is too much fluid in the body, is a major issue among critically ill children and adults, and when left untreated, it can lead to life-threatening consequences. Available therapies require very high relative extracorporeal blood volumes, which can be challenging for pediatric patients. In a retrospective, multi-center study, 32 critically ill pediatric patients weighing over 20 kgs and predominantly suffering from hypervolemia were treated with the Aquadex FlexFlow System and 97% (31/32) survived to the end of therapy.2
About the Aquadex SmartFlow System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
About CHF Solutions
CHF Solutions, Inc. (CHFS) is a medical device company dedicated to changing the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on developing, manufacturing and commercializing the Aquadex SmartFlow™ system for ultrafiltration therapy. CHF Solutions is headquartered in Minneapolis, Minn., with wholly-owned subsidiaries in Australia and Ireland. The company has been listed on the Nasdaq Capital Market since February 2012.
Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements about the clinical outcomes associated with the treatment of fluid overload in pediatric patients. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, the risks associated with our expectations regarding the potential impacts of the COVID-19 pandemic on our business operations, the risks associated with our ability to execute on our commercial strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. CHF Solutions does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.