FDA Approves Temporary Pump to Assist Heart's Right Side

The U.S. Food and Drug Administration has approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart.

Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen.

HDEs facilitate the development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the United States every year. To receive approval of an HDE application, a company must demonstrate the product's safety and probable benefit. Such products are generally used under the supervision of an Institutional Review Board, a committee that approves, monitors, and reviews biomedical research within a locality.

"This device will provide patients with much needed time until a more permanent treatment option is available," said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "The approval reaffirms the FDA's commitment to even the smallest patient populations."

The CentriMag system is for critically ill patients with a failing right ventricle when other therapies have failed. It is intended to be used for up to 14 days to keep the patients alive until their heart recovers or until a heart transplant or long-term heart assist device can be implanted.

While severe right-side heart failure is uncommon, it can lead to death. It is often caused by left-side heart failure or, in unusual cases, by heart surgery. According to FDA, safety data from two multi-center clinical trials showed that the CentriMag system does not expose patients to an unreasonable risk, and the probable health benefit from use of the device outweighs the risk, taking into account the probable risks and benefits of alternative forms of treatment.

Because shortness of breath is common in patients with right-sided heart failure, it is unclear whether the device caused any of the breathing difficulties reported in the study group. The CentriMag Right Ventricular Assist System is manufactured by Levitronix LLC, Waltham, Mass.

Download Center

HTML - No Current Item Deck
  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Steps to Conduct a JSA

    We've put together a comprehensive step-by-step guide to help you perform a job safety analysis (JSA), which includes a pre-built, JSA checklist and template, steps of a JSA, list of potential job hazards, and an overview of hazard control hierarchy.

  • Levels of a Risk Matrix

    Risk matrices come in many different shapes and sizes. Understanding the components of a risk matrix will allow you and your organization to manage risk effectively.

  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Industry Safe
TenCate FR Technology

OH&S Digital Edition

  • OHS Magazine Digital Edition - October 2020

    October 2020

    Featuring:

    • FACILITY SECURITY
      EHS Compliance: Make it Personal
    • FOOT PROTECTION
      Choosing the Right Safety Shoe for Your Industry
    • HAND PROTECTION
      A Requirements Checklists for Work Safety Gloves
    • COVID-19 MANAGEMENT
      Contemporary Issues in HSE Management
    View This Issue