The US Food and Drug Administration (FDA) has approved BioTrace Medical's temporary pacing technology for transcatheter aortic valve procedures (TAVR) and other cardiovascular applications.
The Tempo Lead is indicated for use in procedures in which temporary pacing is indicated, including TAVR and electrophysiology (EP) procedures.
The temporary pacing lead, a small catheter with two electrodes, is placed in the right ventricle of the heart through a vain in the groin or neck. The lead is then connected to an external pacemaker. This allows a physician to control a patient’s heart rate for up to several days.
BioTrace says that the regular or conventional temporary pacing leads can cause serious complications. The leads of a regular temporary pacing system could easily get dislodged from heart and can result in loss of pacing and can even put the patient’s life in jeopardy.
As a result, patients are confined to bed rest during the temporary pacing lead placement. This can delay ambulation and increase the length of the stay in costly hospital units such as intensive care.
Apart from this conventional temporary pacing leads could damage or perforate heart walls, which can lead to periodic effusion and tamponade, where blood from within the heart can escape into the sac surrounding the heart and create cardiac compression which can be life threatening.
Leads of Temp from BioTrace Medical have been designed for secure and stable cardiac pacing with the goal of reducing complications and reducing delay in ambulation sooner after the procedures.
BioTrace Medical CEO Laura Dietch said: “FDA clearance is an exciting milestone for BioTrace.
“We are pleased to bring this important innovation to the significant and growing number of patients needing better temporary pacing options to minimize risks and life-threatening complications. We look forward to launching in select U.S. centers in the coming weeks.”