EBR’s wireless cardiac pacing system gains FDA breakthrough status

GlobalData Healthcare 1 October 2019 (Last Updated October 1st, 2019 11:42)

The device, produced by EBR Systems, provides fresh hope for patients at risk of heart failure for whom conventional therapy has not proved successful.

EBR’s wireless cardiac pacing system gains FDA breakthrough status

The WiSE (Wireless Stimulation Endocardially) cardiac pacing device received breakthrough designation status from the US Food and Drug Administration (FDA) in September.

The device, produced by EBR Systems, provides fresh hope for patients at risk of heart failure for whom conventional therapy has not proved successful.

Heart failure is a condition where the heart cannot adequately pump blood to satisfy the body’s needs. In some cases, heart failure is caused by the lack of synchrony between the right and the left heart ventricles.

Traditionally patients with this condition are treated with cardiac resynchronisation therapy (CRT). CRT includes a pacemaker that is implanted under the skin, two wires that are placed in the right ventricle, and a third wire that is placed on the outside of the left ventricle. The left ventricle wire implantation procedure is complex and in some cases may not function efficiently due to it being placed outside of the heart. Placing the wire inside the left ventricle can cause complications such as heart attack and stroke.

To combat this problem the WiSE system places a small receiver (the size of a grain of rice) inside the patient’s left ventricle. The receiver works wirelessly and the pacing stimulation is sent directly to the inside of the left ventricle. This system is customisable, where the placement of the receiver can be changed according to the patient’s needs.

So far clinical trials have been successful. The SELECT-LV study examined 35 patients failed by traditional CRT and found that the WiSE system was successful at achieving cardiac resynchronisation at one month for 33 patients and clinical benefits at six months for 28 of the patients.

Another clinical trial with 350 participants is currently underway in the US, Europe, and Australia. The WiSE system received the European CE mark approval in 2015. The system is not yet approved for sale in the US. However, the FDA device breakthrough status will allow for an enhanced review process, including priority review.