Subject: FDA
preCARDIA, Inc. Receives FDA Breakthrough Device Designation for Novel, Catheter Based Heart Failure Treatment
ST. PAUL, Minn., June 23, 2020 /PRNewswire/ -- preCARDIA, Inc., has announced that the company's catheter based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA).
The FDA's Breakthrough Device Program was established for medical technologies that have the potential to provide more effective treatment or diagnosis of life threatening diseases or conditions. The program provides preCARDIA with priority review and engagement with FDA experts from the beginning of the premarket review phase through commercialization decisions. In addition, the Centers for Medicare and Medicaid Services (CMS) has created an alternative new technology add-on payment pathway for technologies that have been granted a breakthrough device designation.
The preCARDIA system is intended to rapidly and effectively reduce congestion in the venous system, known as cardiac preload, thereby improving overall cardio-renal function. The potential benefits for patients include improved response to medical management, reducing rehospitalizations, and improved quality of life. The system is currently under investigation in the VENUS-HF Early Feasibility Study.
"preCARDIA's technology has achieved an important milestone in securing the FDA's Breakthrough Device Designation. We are thrilled to move forward in our collaboration with the FDA, prioritizing our submission reviews and supporting rapid access to this therapy for ADHF patients," said Lisa Wipperman Heine, preCARDIA's President and CEO.
About Acute Decompensated HF (ADHF):
Approximately 1.8 million patients are admitted to hospitals with ADHF in the United States annually 1 and it is the leading cause of hospitalization in patients older than 65 years of age.2 Mortality after ADHF hospitalization approaches 30% annually and readmission is common, despite available pharmacotherapy and device based heart failure treatments.1,3
Most ADHF patients have significant volume overload and congestive symptoms which are strong predictors of outcomes. 4 All current therapeutic approaches are palliative, alleviating some symptoms, however ADHF patients continue to have poor morbidity and mortality outcomes. There remains a need for new therapies focused on providing effective and efficient cardio-renal volume unloading in the ADHF patient population.
About preCARDIA, Inc.:
preCARDIA is dedicated to improving patients' quality of life through pioneering clinically advanced technology that offers an alternative solution for physicians and their patients suffering from ADHF. preCARDIA's current technology, a proprietary balloon catheter and pump controller, is designed to address ADHF through cardio-renal volume unloading via intermittent superior vena cava (SVC) occlusion.
The company was founded & incubated by MD Start and is headquartered in St. Paul, Minnesota, USA.
The preCARDIA System is an investigational device and is limited by Federal (or United States) Law to investigational use. www.precardia.com
1. Am. Journal of Epidemiology, 2016; 183(5): 462-470. 1998-2011
2. Am Heart J. 2003; 145: S18-S25.
3. Circulation Heart Failure 2010; 3(1): 97-103.
4. J Card Fail. 2016; 22(3): 182-189.
Media Inquiries:
Tricia Haydon
+1(612) 308-8348
SOURCE preCARDIA, Inc.
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