Medical device and MedTech insights, news, tips and more

Breakthrough Device Designation Given for preCARDIA’s Catheter Based Heart Failure Treatment

June 23, 2020

preCardia logo

preCARDIA, Inc., has announced that the company’s catheter based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA).

The FDA’s Breakthrough Device Program was established for medical technologies that have the potential to provide more effective treatment or diagnosis of life threatening diseases or conditions.  The program provides preCARDIA with priority review and engagement with FDA experts from the beginning of the premarket review phase through commercialization decisions.  In addition, the Centers for Medicare and Medicaid Services (CMS) has created an alternative new technology add-on payment pathway for technologies that have been granted a breakthrough device designation.

The preCARDIA system is intended to rapidly and effectively reduce congestion in the venous system, known as cardiac preload, thereby improving overall cardio-renal function.  The potential benefits for patients include improved response to medical management, reducing rehospitalizations, and improved quality of life.  The system is currently under investigation in the VENUS-HF Early Feasibility Study.

“preCARDIA’s technology has achieved an important milestone in securing the FDA’s Breakthrough Device Designation.  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,” said Lisa Wipperman Heine, preCARDIA’s President and CEO.

Source: preCARDIA, Inc. Receives FDA Breakthrough Device Designation for Novel, Catheter Based Heart Failure Treatment

Press Release by: preCARDIA, Inc.

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?

Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.