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HeartWare Halts Trial for MVAD

Abi Reyes1 year ago

HeartWare International has cancelled enrollment for clinical trials of its next-generation Miniaturized Ventricular Assist Device (MVAD) heart pump.

About the MVAD Trial Pause

According to MassDevice, HeartWare International announced last Wednesdy that it is pausing enrollment in a clinical trial of its MVAD heart pump. HeartWare is seeking to fix a concern with the manufacturing process for the left ventricular assist device’s controller.

HeartWare’s own CEO, Doug Godshall, says the problem is in the way a circuit board is fastened in the controller. HeartWare is supposed to have an upgrade of the manufacturing process by late September or October.

Clinical studies would resume in July and are set to enroll around 60 patients. The potential patients would be implanted with the MVAD pump, with a survival endpoint goal of six months.

The pausing of the trial is expected to set back the expected timeline on the MVAD pump by one to two months. 

Controller Issues Associated with Previous Devices

This is not the first time HeartWare International has had issued with their ventricular assist device controllers.

Last year, HeartWare came under scrutiny following 27 complaints concerning controller failure due to electrostatic discharge. The defect was linked to four serious injuries and two deaths.

An FDA inspection of a HeartWare manufacturing plant resulted in the manufacturer receiving warning letters from the regulator in January and June of last year.

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