FAQ
Is heart failure a significant problem?
Heart Failure is the fastest growing form of cardiovascular disease worldwide with over 1 Million new cases per year. In the U.S. over 6 million people suffer from heart failure with up to 20% suffering from an advanced form of the disease (Class 3 and 4). This results in over 1 million hospitalizations each year that cost the healthcare system over $30 billion. According to the American Heart Association, the prevalence of heart failure is expected to increase by 46% through 2030, resulting in over 8 million patients and at a cost of over $72B. Over half of patients are readmitted and 440,000 suffer from acute or chronic kidney failure, and one third will die within the first year.
What is the regulatory status of Second Heart's products?
Second Heart is currently conducting OUS clinical studies and has identified the US sites that will be used for the clinical trials that will be necessary for FDA and CE Mark approval.
What is Second Heart's intellectual property?
Second Heart Assist’s unique platform design has a formidable intellectual property portfolio that includes patents which span from our current catheter product into wireless capabilities unmet by competitive devices.
How does Second Heart compare to the competition?
We believe studies will prove that competing products are more difficult to place, have lower flow rates, generate more hemolysis, and do not provide the improvements in renal function then that of Second Heart’s platform. NOTE – Controlled all studies are not fully complete yet and thus any product performance claims are subject to data forthcoming which is not available yet. Any data shared is preliminary from early stage un-controlled lab testing for flow rates and other performance parameters or early indications from the first large animal studies which is not statistically significant to draw conclusions on actual final performance. See other more comprehensive warnings, precautions and disclaimers in other sections of this web site and our annual report. This forward looking statement is subject to Safe Harbor. NOT AVAILABLE FOR SALE. Early stage development still under testing. Safety or efficacy has not yet been proven yet.