preCARDIA, a St. Paul, Minnesota-based healthcare technology company, announced that its catheter-based system for acutely decompensated heart failure has received the FDA’s breakthrough device designation.
The system is designed to limit congestion in a patient’s venous system, improving their overall cardio-renal function. Its effectiveness is currently being assessed in the VENUS-HF Early Feasibility Study.
Lisa Wipperman Heine, preCARDIA’s president and CEO, described the news as “an important milestone.”
“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,” she said in a prepared statement.
Medical devices in the Breakthrough Devices Program gain access to FDA experts, and the companies receive “prioritized review” for all related submissions. More information on the program is available on the agency’s website.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.