Abiomed received FDA approval for its Impella 2.5 heart pump to be used during elective and urgent high risk percutaneous coronary interventions. The device moves 2.5 liters of blood per minute, assisting the left ventricle during procedures involving temporary coronary occlusions that would otherwise be too taxing on the already weak heart.
It’s intended for up to six hours of use, but the indication allows the clinical team to decide to keep the patient on it for longer.
Some details on the approval from Abiomed:
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 revascularization (either PCI or surgery). This decision is made based on a pre-defined institutional protocol or on a per patient basis. If the protocol determines that PCI is appropriate, Impella is the only hemodynamic support device proven safe and effective for high risk PCI. This heart team approach has also been utilized 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 PCI 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, M.D., Henry Ford Hospital in Detroit. “The heart team approach has evolved into a mainstream practice recognized by the guidelines for determining the need for PCI versus surgery and will continue to act as a platform for the screening and determination of the appropriate revascularization treatment for this high risk patient population.”
In addition to the U.S. clinical trial data, the Impella 2.5 PMA submission included clinical and scientific supporting evidence from more than 215 publications, totaling 1,638 Impella 2.5 patients and incorporated a medical device reporting (MDR) 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 U.S. Impella registry. The U.S. registry is an ongoing multicenter, observational retrospective registry including 49 centers. The data collection from the registry includes Institutional Review Board (IRB) approval, complete data monitoring and Clinical Events Committee adjudication. Additionally, the PMA analysis included hemodynamic science described in the literature and validated with a series of pre-clinical and clinical studies.
Here’s an animation showing off the Impella 2.5 pump:
Flashbacks: Impella 2.5 Heart Pump Given Green Light in US…; Abiomed Impella 2.5 Left Ventricular Assist Device Demo…; Video of Impella 2.5 Heart Assist Pump Used in Minimally Invasive Procedure…; Impella 2.5 Heart Pump Performs Well in a Feasibility Trial…; Abiomed Reports New Positive Impella 2.5 Results…; MINI-AMI Study To Evaluate Impella 2.5 for Reduction of Infarct Size…
Product page: Impella 2.5…