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.

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.

Novel Therapeutic Approach Effective at Reducing Pressure for Heart Failure Patients

First-in-man study shows potential to improve outcomes for common cardiac condition impacting 26 million people worldwide

Novel Therapeutic Approach Effective at Reducing Pressure for Heart Failure Patients

Image courtesy of Kapur N.K., Karas R.H., Burkhoff D., et al.

June 17, 2019 – Results from a first-in-man proof of concept study found occlusion of the superior vena cava (SVC) rapidly and effectively reduces pressure and volume in the heart. This is the first study targeting the SVC as a therapeutic area for heart failure patients to reduce cardiac filling pressures without reducing cardiac output or systemic blood pressure. Data was presented as late-breaking clinical research at the Society for Cardiovascular Angiography and Interventions (SCAI) 2019 Scientific Sessions, May 19-22 in Las Vegas.

Heart failure is a growing public health crisis, impacting 5.7 million adults in the United States and 26 million people worldwide. This common cardiac condition occurs when the heart is too weak or damaged to pump enough blood and oxygen to support other organs in the body, and is responsible for more than $30 billion in healthcare costs in the U.S. each year. Current treatment options to treat volume overload during heart failure include drug therapy, diuresis and kidney replacement therapies such as hemodialysis.

Eight patients admitted with systolic heart failure and volume overload were included in the study. An endovascular balloon was used to occlude the SVC for five to ten minutes. To assure safety, patients underwent neurological testing before, during and after SVC occlusion with repeat testing within 10 minutes of balloon release, and after one, three and 24 hours.

Successful SVC occlusion was performed on all patients within the study. After five minutes of SVC occlusion heart pressures became normal, systemic blood pressure stayed stable and heart function was stable. In the last three patients, a second SVC occlusion was performed for 10 minutes with similar hemodynamic findings. After seven days of followup for all eight patients and 30-day followup for five patients, no neurologic or vascular consequences were reported.

“Global heart failure rates are continuing to rise along with hospital readmission rates. Our ultimate objective is to improve patient outcomes by shortening their time in the hospital, reducing their symptoms and improving their response to diuretics,” said Navin K. Kapur, M.D., FSCAI, The CardioVascular Center, Tufts Medical Center in Boston. “Our findings show the potential to improve cardiac filling pressures and function in acute heart failure using a minimally invasive procedure. Going forward, this therapy could be applied to other heart conditions, especially those where little to no treatment option currently exist.”

To further verify these findings, the U.S. Food and Drug Administration (FDA) recently approved an early feasibility and safety clinical trial entitled VENUS-HF, which is sponsored by PreCardia Inc.

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