FDA Grants Emergency Use Authorization to Abiomed for Impella RP

FDA Grants Emergency Use Authorization for Abiomed Impella RP
The Impella RP provides pulmonary support in patients experiencing right side ventricular failure. Image courtesy of Abiomed.

Abiomed has been granted FDA emergency use authorization for its Impella RP – a temporary heart pump to support circulatory system functioning in patients with right side ventricular failure. The FDA has granted EUA for this device to treat COVID-19 patients, as some of them have suffered from right heart failure due to the virus, from complications such as pulmonary embolism. Heart disease is the leading cause of death in America, and COVID-19 is exacerbating this issue.

This emergency use authorization comes at a time of particular need for cardiology care improvements. In addition to this increased risk of heart complications, many Americans are fearful of receiving medical care due to possible virus exposure. This was revealed in a recent U.S. national survey conducted by the Society for Cardiovascular Angiography and Intervention. This survey showed that 40% of respondents regarded hospital visits as risky behaviour. This could help explain why, as reported by the American College of Emergency Physicians, admissions for heart attacks have dropped recently by approximately 60%.

The Impella RP can provide support for COVID-19 patients with right ventricular failure with rapid deployment, and with minimal invasiveness. It can also be used in combination with left-side Impella devices, to provide support to both ventricles.

Amir Kaki, M.D., interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, spoke out in support of this device. He stated that “Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic. As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be life-saving.”

Via: Abiomed, DAIC

Interventional Cardiology Device Market

The U.S. interventional cardiology device market was valued at $2.87 billion in 2017. This is expected to increase at a CAGR of 1% by 2024, primarily driven by increasing procedure volume, and the growth of specialized devices, such as the Impella RP from Abiomed. To read more on the interventional cardiology market, including interviews, procedural volumes, and forecasts, refer to iData Research’s report page on Cardiovascular Markets or request a free sample of our latest report Interventional Cardiology Market Analysis, Size, Trends | Global | 2018-2024 | MedSuite.

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