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Annually, more than one million patients are admitted to hospitals in
preCARDIA’s catheter-based system includes a proprietary superior vena cava (SVC) balloon that delivers programmed intermittent occlusion of the SVC. Potential benefits for patients include improved response to medical management of ADHF, reduced duration of hospital stay, reduced re-hospitalizations and improved quality of life. The system is based on an invention by
The design of the preCARDIA system allows for straightforward placement by physicians and hemodynamic monitoring by medical staff. The system has received Breakthrough Device Designation by the
“Abiomed, with its mission of resting and recovering hearts, is uniquely positioned to build on the legacy of what we started,” said
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
“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
The preCARDIA system is available for investigational use only and is not approved for use outside of clinical studies. A projected timeline for commercialization will be announced later this fiscal year.
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 through cardio-renal volume unloading via intermittent superior vena cava (SVC) occlusion.
The company was founded & incubated by MD Start and is headquartered in
CAUTION: The preCARDIA System is an investigational device and is limited by Federal (or
Any forward-looking statements are subject to risks and uncertainties such as those described in