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preCARDIA Acquired by Abiomed to Improve Heart Failure Patients

Abiomed has acquired preCARDIA, a unique catheter and controller developer that will extend choices for patients with acute decompensated heart failure by complementing Abiomed’s product line. The preCARDIA system is specially intended to quickly treat ADHF-related volume overload by lowering ventricular filling pressures and facilitating decongestion, improving overall cardiac and renal function.

In the United States, more than one million patients with ADHF are admitted to hospitals each year. Heart failure is the leading cause of hospitalization in adults over the age of 65, despite the availability of pharmaceutical treatments. preCARDIA offers heart failure doctors a minimally invasive alternative that can enhance patient outcomes and reduce healthcare costs by allowing for early intervention.

A patented superior vena cava (SVC) balloon is used in preCARDIA catheter-based device to administer planned intermittent blockage of the SVC. Higher response to the medical care of ADHF, shorter hospital stays, fewer re-hospitalizations, and improved quality of life are all potential benefits for patients.

The technique was developed by Navin Kapur, MD, and Richard Karas, MD, Ph.D., of Tufts Medical Center in Boston’s Molecular Cardiology Research Institute. The preCARDIA system’s architecture enables simple placement by physicians and hemodynamic monitoring by medical personnel.

The US Food and Drug Administration has designated the system as a Breakthrough Device (FDA). In an FDA early feasibility study (EFS), preCARDIA enrolled 30 patients, demonstrating critical technical success as well as significant reductions in ventricular filling pressures and rapid diuresis. In addition, after 30 days, all patients had no serious adverse effects connected to the device or treatment.

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