St. Paul, MN-based preCARDIA has developed a catheter-based system designed to rapidly treat ADHF-related volume overload.

Omar Ford

June 3, 2021

2 Min Read

Abiomed is augmenting its heart failure treatment offerings with the acquisition of preCARDIA for an undisclosed sum.

St. Paul, MN-based preCARDIA has developed a catheter-based system designed to rapidly treat ADHF-related volume overload by reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function. The system includes a superior vena cava (SVC) balloon that delivers programmed intermittent occlusion of the SVC.

PreCardia won breakthrough device designation for the heart failure treatment system in June of 2020.

Danvers, MA-based Abiomed said the system will complement its product portfolio to expand options for patients with acute decompensated heart failure. Recently, preCARDIA completed enrollment of 30 patients in an FDA early feasibility study (EFS), which demonstrated acute technical success and significant reduction in cardiac filling pressures and rapid diuresis. Additionally, all patients were free of device- or procedure-related major adverse events through 30 days.

Abiomed said a projected timeline for commercialization of PreCardia’s system would be announced later this year.

“We look forward to advancing preCARDIA’s technology through the regulatory process and expanding our relationship with heart failure specialists to help improve outcomes in early stage acute decompensated heart failure patients, a new patient population for Abiomed,” said Michael Minogue, Abiomed’s Chairman, president and CEO. “This acquisition aligns with Abiomed’s principles of leading in technology and innovation and putting patients first.”

Making Moves During the Pandemic

Like many in the industry, Abiomed journeyed into COVID-19 territory with some of its solutions and deals. The company was granted Emergency Use Authorization for the Impella RP to include patients suffering from COVID-19 related right and heart failure or decompensation, including pulmonary embolism. The firm won a second EUA specifically related to the Impella heart pumps providing left ventricular unloading and support.

In April, the company announced it acquired Breethe, a developer of an extracorporeal membrane oxygenation system for an undisclosed sum. The Baltimore, MD-based company’s ECMO System has the potential to serve the needs of patients whose lungs can longer provide sufficient oxygenation, including patients suffering from cardiogenic shock, cardiac arrest or respiratory failure such as due to ARDS, H1N1, SARS, or COVID-19.

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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