logo
  

Abiomed's Impella RP With SmartAssist Gets FDA Pre-market Approval To Treat Right Heart Failure

Abiomed Inc. (ABMD), on Tuesday, announced that its newest right heart pump, the Impella RP with SmartAssist, has received U.S. Food and Drug Administration pre-market approval or PMA as safe and effective to treat acute right heart failure for up to 14 days.

Impella RP with SmartAssist is the first single-access temporary percutaneous ventricular support device with dual-sensor technology. Impella RP with SmartAssist is an advancement of Impella RP, which was granted a PMA by the FDA in 2017 and has treated thousands of patients globally with right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Additionally in June 2020, the FDA issued an emergency use authorization or EUA for Impella RP as a treatment for patients suffering from COVID-19-related right heart failure or decompensation, including pulmonary embolism (PE).

The Impella RP with SmartAssist System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area =1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Further, the company noted that Impella RP with SmartAssist would be introduced in the United States through a controlled rollout at hospitals that follow cardiogenic shock best practice protocols.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Financial services firm Morgan Stanley (MS) reported Wednesday a profit for the fourth quarter that increased 10 percent from last year, reflecting 7 percent revenue growth amidst strength in Wealth Management and Investment Management business segments. Bank of America Corp. (BAC) reported Thursday that net income applicable to common shareholders for the fourth quarter grew 30 percent to $6.77 billion from last year's $5.21 billion, with earnings per share increasing to $0.82 from $0.59 in the prior year, reflecting strong operating leverage as revenues... Shares of ASML Holding N.V. were gaining more than 1 percent in Amsterdam trading after the Dutch semiconductor equipment maker reported Wednesday higher profit and net sales in its fourth quarter. The company also projects higher sales in fiscal 2022, and a 100 percent increase in total dividend.
Follow RTT