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
  • 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.

  • Easy to Use Safety Incident App

    Record incidents on the go with IndustrySafe’s mobile app. Collect data for multiple types of incidents including including near misses, vehicle and environmental incidents, and employee and non-employee injuries; at job sites and remote locations—with or without web access.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. IndustrySafe is here to help. We put together a resource that’s easy to digest so you can get answers to your training questions and ensure you're complying with OSHA's standards.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus