Abiomed (NSDQ:ABMD) said today that it won CE Mark approval in the European Union for its Impella 5.5 heart pump, saying that the first patient in Europe has already been treated with the device.
The Danvers, Mass.-based company said that Dr. Alexander Bernhardt, under the guidance of Dr. Hermann Reichspurner, performed the first procedure in the region at Hamburg, Germany’s University Heart Center.
“The Impella 5.5 device is an easy to implant, minimally-invasive device that provides full cardiac flow and stabilizes the patient by increasing cardiac power output, unloading the left ventricle and perfusing the coronaries and end organs. This approval gives our cardiovascular community a new option for effectively treating severely ill patients,” Dr. Reichenspurner said in a prepared statement.
The newly cleared, next-gen Impella 5.5 pump is cleared in the EU to provide a 30-day, ambulatory, wean-able forward-flow heart pump, Abiomed said.
Approval of the Impella 5.5 system was supported by pre-clinical data, including clinical experiences from more than 3,000 patients, Abiomed said. The approval was also supported by an analysis of 68 patients from the company’s FDA reviewed cVAD registry and a literature review of eight papers covering patients treated with the Impella 5.0 unit.
“We are excited about the Impella 5.5 and the impact of fully unloading the left ventricle. We commend the dedication of the team at University Heart Center Hamburg. The addition of the Impella 5.5 to the Impella platform of devices will further address the clinical needs of patients and physicians as we advance the field of heart recovery,” prez & CEO Michael Minogue said in a press release.
Earlier this week, Abiomed said it won FDA pre-market approval for its next-gen Impella CP heart pump with the SmartAssist optical sensor.
