BioTrace Medical has treated the first patients in the US undergoing transcatheter aortic valve replacement (TAVR) procedures using its Tempo temporary pacing lead.
In the procedure, this temporary pacing lead and a small catheter with two electrodes are placed in the right ventricle of the heart through a vein in the groin or neck. The lead is then connected to an external pacemaker enabling the monitoring and controlling of a patient’s heart rate for several days.
The Tempo Lead has been designed to facilitate safe and stable cardiac pacing. It is intended to reduce complications and allow patients to move around sooner after surgery.
The device features an active fixation mechanism, with bipolar electrodes and a soft tip. It consists of an elastomeric balloon, which may be inflated to help the lead orientate through the venous vasculature and into the right ventricle.
BioTrace Medical's scientific advisory board member and Columbia University's Medical Center for interventional vascular therapy director Martin Leon said: “BioTrace’s temporary pacing leads are an exciting advance over existing technologies, which can cause complications that result in poor clinical outcomes and longer hospital stays.
“The Tempo Lead is designed to alleviate the risks associated with lead dislodgement and inconsistent pacing, providing a safer option for patients.”
In a multi-centre study, the lead demonstrated its safe usage in the successful treatment of 23 patients, with no loss of pace capture or lead dislodgement of the device from within the heart.