Abiomed’s Successful Pilot Study Leads to Pivotal Trial

The Danvers, MA had strong data at the American Heart Association, however the firm’s shares were down as much as 17% on Monday.

Abiomed shares were down as much as 17% despite announcing positive data for its Impella CP. The Danvers, MA-based company presented the data from the 50-patient pilot trial at the American Heart Association annual conference in Chicago and said because of the favorable data it would now move to a pivotal trial.

The results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately. The results were simultaneously published in Circulation.

Unloading first and delaying reperfusion by 30 minutes did not increase 30-day major adverse cardiovascular and cerebrovascular events (MACCE) or infarct size, compared to the immediate reperfusion arm of the trial. Infarct size is a measure of damage to the heart muscle after a heart attack.

It is feasible to delay reperfusion in a heart attack (STEMI) patient in a clinical trial, as demonstrated by a 100% adherence to the 30-minute unloading protocol and 100% Impella CP insertion success in both study arms.

Unloading the left ventricle for 30 minutes prior to reperfusion appears to reduce infarct size as a percentage of area at risk among patients with a ST sum greater than 6.

“If a reduction of infarct size from unloading before reperfusion is confirmed in a future trial, this concept would enhance the existing guidelines of immediate reperfusion for STEMI patients,” Navin Kapur, MD, a principle investigator of the trial said in a release. “75% of patients experiencing their first heart attack will develop heart failure within five years, so new approaches are needed to reduce infarct size and prevent heart failure. Pre-clinical non-human data sets show unloading the left ventricle prior to reperfusion activates a cardioprotective program that reduces reperfusion injury, and could improve the current standard of care.”

Abiomed obtained the heart pump technology when it acquired Aachen, Germany-based Impella CardioSystems AG in 2005. The company has been keeping steady momentum and last year it was among MD+DI's 2017 Company of the Yearfinalists.

Earlier this year, Abiomed received FDA approval for its Impella CP heart pump with SmartAssist using an optical sensor. The sensor is one component of the SmartAssist technology, which also includes a software update enabling informational displays of left ventricular pressure, end-diastolic pressure, and cardiac power output data on the Impella Console. In July, Abiomed landed on the 25 most attractive medtech companies on the M&A radar list.

Most recently, the company dominated its quarterly earnings posting revenues of $181.8 million topping analyst consensus of $175.2 million.

 

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