preCARDIA Enrolls First Patient in Early Feasibility Study
ST. PAUL, Minn., Aug. 15, 2019 /PRNewswire/ — preCARDIA, Inc., a medical device company developing innovative technologies for the treatment of acute decompensated heart failure (ADHF), has enrolled the first patient in the VENUS-HF Early Feasibility Study at Tufts Medical Center in Boston by Dr. Carey Kimmelstiel, Director, Interventional Cardiology Center, and Dr. Michael Kiernan, Director, Ventricular Assist Device Program.
VENUS-HF is a United States-based early feasibility Investigational Device Exemption (IDE) study using the preCARDIA system as a therapeutic approach for significantly congested patients suffering from ADHF who are not diuresing adequately.
“The current ADHF treatment approaches are sub-optimal in many patients and have not improved over the past twenty years, thus new treatment options are critical,” said Navin Kapur, M.D., Director of the Acute Circulatory Support Program at Tufts Medical Center, and Chief Medical Advisor and Chair of preCARDIA’s Scientific Advisory Board. “We are excited to be pioneering a novel, minimally-invasive transcatheter treatment approach that has the potential to greatly improve the lives of patients suffering from ADHF.”
“This study is an important milestone for preCARDIA in providing critical safety and performance data. Our innovative device — targeted specifically for patients suffering from ADHF — has the potential to fill a critical unmet need in this population,” said Lisa Wipperman Heine, preCARDIA’s President and CEO.
About Acute Decompensated HF (ADHF):
Approximately 1.8 million patients are admitted with ADHF in the United States annually 1 and it is the leading cause of hospitalization in patients older than 65 years of age2. Mortality after ADHF hospitalization approaches 30% annually and readmission is common, despite treatment with currently available pharmacotherapy and device therapy for HF 1,3. Most ADHF patients have significant volume overload and congestive symptoms which are strong predictors of outcomes 4. Despite currently available treatments, ADHF remains associated with a poor quality of life and high mortality. All current therapeutic approaches are palliative and may alleviate some symptoms, but many patients continue to worsen. There is a need for new therapies to focus on the critical time during hospitalization.
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 via intermittent superior vena cava (SVC) occlusion. By limiting venous return to the heart, preCARDIA treats fundamental ADHF clinical hemodynamic targets. 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.