Advertisement

May 2, 2019

FDA Approves Abiomed's STEMI DTU Trial of Delayed Reperfusion With Impella CP

May 2, 2019—Abiomed, Inc. announced that the FDA has approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) pivotal randomized controlled trial. The trial will test the hypothesis that unloading the left ventricle for 30 minutes before reperfusion will reduce myocardial damage from a heart attack and lead to a reduction in future heart failure–related events.

According to the company, the prospective, multicenter, two-arm trial plans to enroll 668 patients undergoing treatment for STEMI at up to 60 sites. Half of the patients will be randomized to receive delayed reperfusion after 30 minutes of left ventricular unloading with the company's Impella CP device. The other half will receive immediate reperfusion, which is the current standard of care.

Additionally, the protocol requires each site to “roll in” two patients (one in each arm) to test the study protocol before beginning enrollment. The trial allows for an adaptive design, which permits adjustments to the study sample size after an interim analysis.

According to Abiomed, the primary endpoint is infarct size as a percent of left ventricular mass, measured at 3 to 5 days using cardiac MRI. Key secondary effectiveness endpoints include a composite of the primary endpoint and the following: cardiogenic shock after 24 hours postenrollment out to 30 days, cardiovascular mortality at 24 months, heart failure requiring hospitalization at 24 months, and implantable cardioverter defibrillator and cardiac resynchronization therapy placement at 24 months. The trial is powered for multiple other secondary endpoints and has numerous exploratory endpoints, such as infarct size to area at risk. The company provided a detailed protocol synopsis of the trial available online here.

The company expects to begin enrollment in October 2019 and end in 3 to 4 years (2022–2023). At 6 months after completion of enrollment, Abiomed will make an FDA submission for indication approval based on primary endpoint and safety data analysis. Impella heart pumps are not FDA approved for use in STEMI patients without cardiogenic shock, advised Abiomed.

Navin Kapur, MD, is Coprincipal Investigator of the study and Executive Director of the CardioVascular Center for Research and Innovation at Tufts Medical Center in Boston, Massachusetts.

In the company's press release, Dr. Kapur commented, “The STEMI DTU pivotal trial has the potential to improve the standard of care, slow the growing epidemic of heart failure, and improve outcomes for millions of heart attack patients. This trial is the first of its kind to focus on ventricular unloading as part of a therapeutic approach for heart attacks without cardiogenic shock and could lead to a paradigm shift in the way heart attack patients are treated worldwide.”

Advertisement


May 2, 2019

FDA Grants Breakthrough Device Designation for Concept Medical's MagicTouch Sirolimus-Coated Balloon

May 2, 2019

FDA Grants Breakthrough Device Designation for Concept Medical's MagicTouch Sirolimus-Coated Balloon