Abiomed has received US Food and Drug Administration (FDA) pre-market approval for the Impella 2.5 heart pump during elective and urgent high risk percutaneous coronary intervention procedures. This approval is based on the extensive clinical data submitted by Abiomed to the FDA to support this pre-market approval as part of the 515 initiative.
Abiomed says that the Impella 2.5, the world’s smallest heart pump, is the first haemodynamic support device to receive pre-market approval indication for use during high risk percutaneous coronary intervention procedures.
The Impella 2.5 is a temporary (≤6 hours) ventricular support device indicated for use during high risk percutaneous coronary intervention performed in elective or urgent haemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk percutaneous coronary intervention is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent haemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
The product labelling allows for the clinical decision to leave Impella 2.5 in place beyond the intended duration of ≤6 hours due to unforeseen circumstances.
As per the 2011 ACC/AHA guidelines, it is a Class 1 recommendation for a heart team, which includes a cardiac surgeon, to determine the treatment strategy for revascularisation (either percutaneous coronary intervention or surgery). This decision is made based on a pre-defined institutional protocol or on a per patient basis. If the protocol determines that percutaneous coronary intervention is appropriate, Impella is the only haemodynamic support device proven safe and effective for a high risk procedure. The heart team approach has also been utilised for the treatment strategy for heart valve replacement.
“The rigorous data from FDA clinical trials such as PROTECT I and PROTECT II demonstrate that complex, high-risk patients undergoing protected percutaneous coronary intervention with Impella 2.5 support experience reduced adverse events, improved quality of life and are able to return home faster with fewer repeat procedures,” said William O’Neill, Henry Ford Hospital in Detroit, USA. “The heart team approach has evolved into a mainstream practice recognised by the guidelines for determining the need for percutaneous coronary intervention versus surgery and will continue to act as a platform for the screening and determination of the appropriate revascularisation treatment for this high risk patient population.”
In addition to the US clinical trial data, the Impella 2.5 pre-market approval submission included clinical and scientific supporting evidence from more than 215 publications, totalling 1,638 Impella 2.5 patients and incorporated a medical device reporting analysis from 13,981 Impella 2.5 patients. In addition to PROTECT I and PROTECT II, further data was provided in the submission from 637 high risk patients enrolled in the US Impella registry. The US registry is an ongoing multicentre, observational retrospective registry including 49 centres. The data collection from the registry includes Institutional Review Board approval, complete data monitoring and Clinical Events Committee adjudication. Additionally, the pre-market approval analysis included haemodynamic science described in the literature and validated with a series of pre-clinical and clinical studies.
“The FDA’s recognition of this elective and urgent patient population is an important acknowledgement of their growing need for treatment. As heart disease patients get sicker, more complex, and desire minimally invasive solutions, there are few options available to them to help improve their quality of life in a cost effective manner,” said Michael R Minogue, chairman, president and chief executive officer, Abiomed.