CE Mark for Abiomed Impella® RP

Remember Abiomed’s Impella® RP (Right Peripheral) heart pump? We last covered this device as recently as March when the company announced it had completed enrollment in its RECOVER RIGHT IDE study. Now Abiomed tells us it has received CE Mark approval to market the device in the European Union.

Background

The percutaneous Impella RP heart pump provides temporary ventricular support for patients with right ventricular failure. It is implanted through a single access site in the patient’s leg and deployed through the venous system, across the right side of the heart without requiring a surgical procedure.

The CE Mark sees Impella RP System indicated for clinical use in cardiology, in cardiac surgery, and intensive care unit for up to 14 days for the following indications, as well as others:

  • Acute or transient reduction of the right ventricular function (e.g., postcardiotomy low output syndrome);
  • Cardiogenic shock as a consequence of a posterior myocardial infarction with right ventricular heart failure;
  • Right heart support during coronary beating heart bypass surgery, especially for patients with a reduced preoperative cardiac output or for patients having a high risk of developing a postoperative low output syndrome for other reasons;
  • Right ventricular heart failure after implantation of a left ventricular assist device;
  • Therapy unresponsive arrhythmias with a reduction of right ventricular output;
  • Heart failure and/or cardiogenic shock as a consequence of refractory ventricular arrhythmia, as well as a consequence of sustained supraventricular arrhythmias, causing hemodynamic compromise.

Company comments

“We are proud to announce the commercial European availability of the new Impella RP device,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “This exciting news follows our recent announcement of the completion of patient enrollment in the U.S. IDE RECOVER RIGHT trial, which further emphasizes the need for percutaneous support for right sided heart failure in hospitals around the world.”

Source: Abiomed, Inc., Globe Newswire

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