Abiomed, a medical device technology company of Johnson & Johnson MedTech, has announced positive results for its Impella heart pump, from a third-party analysis.
The data showed that physicians using Impella during high-risk percutaneous coronary intervention (HRPCI) procedures achieved more revascularisation compared to high-risk PCIs supported using an intra-aortic balloon pump (IABP).
According to previous studies, more complete revascularisation may result in enhanced survival, reduction in heart failure and angina symptoms, and improved quality of life.
The data from the analysis showed that more patients achieved more complete revascularisation with Impella, when compared to IABP support, said Abiomed.
Royal Brompton and Harefield hospitals consultant interventional cardiologist Vasileios Panoulas presented the data during EuroPCR 2023 in Paris, France.
Panoulas said: “When taking study limitations into account, this pooled analysis showcases the potential of Impella to contribute to improved long-term patient outcomes by allowing a greater extent and quality of revascularisation.”
The pooled data analysis was led by the York Health Economics Consortium (YHEC), an independent research company owned by the University of York (England).
It included data from PROTECT II Randomized Controlled Trial (RCT), PROTECT III and RESTORE-EF studies, along with individual patient data.
The analysis measured the coronary artery disease severity pre-PCI using SYNTAX score and post-PCI using residual SYNTAX Score (rSS).
It compared the complete revascularisation rates between high-risk PCI patients who received Impella support and IABP support.
The results from the multiple regression analysis showed a 40% greater reduction of residual SYNTAX Score post-PCI in patients treated with Impella, than IABP.
Recently, Abiomed has recalled the labelling of Impella RP Flex with Smart Assist System Catheter, intended for patients with acute right heart failure after left ventricular assist device implantation.
The US medical device maker recalled the device due to incorrect instructions for use (IFU), which affect patients whose anticoagulation clotting time is less than the suggested value.
