News | Heart Failure | June 23, 2020

FDA Grants Breakthrough Device Designation for preCardia Catheter-based Heart Failure Treatment

Pioneering technology is designed to address acute decompensated heart failure

Navin Kapur, M.D., Tufts Medical Center, shows preCardia device and its anatomical positioning in the patient to treat heart failure..

Navin Kapur, M.D., Tufts Medical Center, shows preCardia device and its anatomical positioning in the patient.

June 23, 2020 — The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Program status for the preCardia catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF). 

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 device uses a balloon catheter and pump controller that allows intermittent occlusion of the superior vena cava (SVC). 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.  

The device was pioneered at Tufts Medical Center by Navin Kapur, M.D., FAHA, FACC, FSCAI, executive director, The Tufts CardioVascular Center for Research and Innovation (CVCRI), and director of Cardiac Biology Research Center, Molecular Cardiology Research Institute (MCRI). 

"By occluding the superior vena cava intermittently, we can reduce cardiac filling pressures and improve cardiac output, and by reducing right atrial pressures in patients overtly congested with heart failure, we believe this has an unloading effect on the kidney, so it is a device that will really help with cardio-renal unloading," Kapur explained.

He said the hope is the device will enable faster decongestion of the patient so they can be discharged faster, decreasing the average length of stay for heart failure admissions.

"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 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 percent 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.  

The company was founded and incubated by MD Start and is headquartered in St. Paul, Minn.

The preCardia system is an investigational device and is limited by Federal (or United States) Law to investigational use.


Related preCardia and Heartfailure Content:

VIDEO: Occluding the SVC as a Reset Button in Heart Failure — Interview with Navin Kapur, M.D.

New Heart Failure Devices and Drugs to Treat Heart Failure

Novel Therapeutic Approach Effective at Reducing Pressure for Heart Failure Patients



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


Related Content

Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major
TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.