Abiomed, Johnson & Johnson’s small pump manufacturer rose to prominence with devices that aid the affected by relieving the strain on cardiac muscles that are weakened after a slow decline into heart failure. The company has also been looking to offer this to patients who need help after a sudden cardiac arrest.

The company provided the first encouraging results from a randomized test which showed improvements in the six-month survival rates in patients who had an acute myocardial infarction and cardiogenic shock. The 10-year long trial included 355 participants in Germany, Denmark, and the U.K.

Abiomed’s Impella CP catheter-based pump was used to additionally treat a group of patients in comparison to the control group that was only given standard care. Just over 96% of patients had percutaneous coronary interventions to restore blood flow to the heart while the remaining patients were given the artery bypass graft procedure.

The control group had 58.5% of the patients, or 103 out of 176 patients, die within six months, from any cause. In comparison, 45.8%, or 82 out of 179 patients died following the Impella treatment. Company stated that it is a significant 180-day mortality decrease of 12.7%.

A blocked coronary artery causes 10% of the patients to suffer a lethal cardiogenic shock with a heart attack. It is also known as STEMI, or ST-elevated myocardial infarction. They are collectively linked to 40% to 50% mortality rates which are frequently within a day.

Three smaller randomized studies conducted previously that compared standard care to various Impella pumps had failed to show clear benefits. All of these studies had 15 to 48 patients. Director of interventional cardiology at NYU Langone Health, Sunil Rao stated that the positive results from the latest trial could be due to types of patients, the design changes in the study or even the device differences, or it could be a blend of these factors.

He also said that one of the previous studies had more patients who had received resuscitation prior to the treatment, while the latest trial did not include patients with low coma score. He stated the patients in the new trial had a better chance of neurologic recovery that the other trials.

Abiomeds chief medical officer, Chuck Simonton said that he found the gradual improvement in the survival rate with Impella in comparison with the control group. The study showed that the Impella group mortality rate stayed mostly even after 120 days while the control group saw it keep increasing.

Abiomed will keep on studying the use of Impella CP in STEMI cases by emphasizing the exact timing of the treatment; placing the pump for some time prior to PCI procedure. The aim is to enroll nearly 560 patients in the randomized study.

In March, FDA handed down a Class I recall label to heart issues connected to over 66 thousand of Johnson & Johnson’s several Impella pumps for the heart’s left side, with 129 severe injuries and 40 deaths.

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