Getinge said that its intra-aortic balloon pump (IABP) has shown positive results in a pilot study evaluating the balloon therapy for patients with extensive myocardial infarction (MI or heart attack).
The trial, dubbed SEMPER FI, assessed the balloon pump in MI patients whose condition was complicated by persistent ischemia, post percutaneous coronary intervention (PCI).
Getinge said that IABP showed positive trends in reduction of the primary endpoint of the pilot study which was defined as a composite endpoint of mortality, necessity for mechanical support due to hemodynamic deterioration, such as left ventricular assist device [LVAD], and hospital readmission for congestive heart failure at six months.
The Swedish medical device firm said that patients with large acute MI and signs of persistent ischemia after successful stenting have a poor prognosis and are prone to have heart failure at a later stage.
Getinge further said that an estimated 30% of patients with ST elevated MI (STEMI) continue to have persistent ischemia even after opening of the main culprit artery.
The SEMPER FI study enrolled 100 patients aged between 18 and 75 years with acute STEMI. The participants were randomized to IABP for 12 to 24 hours or no IABP as per guidelines to alleviate persisting ischemia will all of them followed up for six months.
Among the patients, subjected to IABP, one patient experienced the primary endpoint compared to 8% that is four patients in the non-IABP group.
Getinge acute care therapies chief medical officer Claudius Diez said: “The trend toward a mortality benefit with the use of IABP observed in the SEMPER FI pilot study is encouraging because the study was well controlled and did not allow crossover from the conventionally-treated group to IABP, which could have confounded the results.
“This pilot study is a testament to Getinge’s commitment to support clinical research to increase the body of knowledge for our life-saving therapies.”