Abiomed buys preCARDIA, a heart failure tech firm

Abiomed acquired preCARDIA, developer of a catheter and controller that will complement Abiomed’s portfolio to expand options for patients with acute decompensated heart failure (ADHF). The preCARDIA system rapidly treats ADHF-related volume overload by reducing cardiac filling pressures and promoting decongestion to improve cardiac and renal function.

preCARDIA’s catheter-based system includes a superior vena cava (SVC) balloon that delivers programmed intermittent SVC occlusion. Potential benefits include improved response to medical management of ADHF, reduced hospital stay duration, reduced re-hospitalizations and improved quality of life. The system is based on an invention by Navin Kapur, MD, and Richard Karas, MD, Ph.D. at the Molecular Cardiology Research Institute at Tufts Medical Center.

preCARDIA’s design allows straightforward placement by physicians and hemodynamic monitoring by medical staff. The system received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

“Abiomed, with its mission of resting and recovering hearts, is uniquely positioned to build on the legacy of what we started,” Lisa Wipperman Heine, president and CEO of preCARDIA told the press. “I am confident that the addition of our technology into Abiomed’s product portfolio will further improve outcomes for heart failure patients.”

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.

“Heart failure is a devastating condition associated with excess fluid overload known as congestion. preCARDIA is a breakthrough technology that regulates blood flowing into the heart known as preload, thereby reducing congestion and improving heart and kidney function,” said Navin Kapur, MD, physician-scientist and investigator in the Molecular Cardiology Research Institute at Tufts Medical Center, and the chief medical advisor and chair of preCARDIA’s Scientific Advisory Board. “This novel approach has the potential to be a revolutionary tool for the treatment of millions of patients suffering from acute heart failure worldwide.”

“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 R. Minogue, Abiomed’s Chairman, president and CEO. “This acquisition aligns with Abiomed’s principles of leading in technology and innovation and putting patients first.”

The preCARDIA system is available for investigational use and isn’t approved for use outside of clinical studies. MPO Mag