EBR Systems Inc. has enrolled and implanted the first patient in its Totally Leadless CRT (TLC-AU) feasibility study in Australia.
The procedure was conducted on Thursday December 11, (Australian time) and performed at Brisbane’s Princess Alexandra Hospital by electrophysiologist Dr Paul Gould. The company’s WiSE® CRT System was implanted alongside an Abbott Aveir™ DR leadless pacemaker to deliver completely leadless cardiac resynchronisation therapy (CRT).
TLC-AU is designed to evaluate the use of WiSE in combination with a leadless right ventricular pacemaker as a fully leadless CRT solution in patients with heart failure. Totally leadless CRT using WiSE with a leadless pacemaker has previously been reported in the medical literature and is already reflected in US FDA-approved labelling for patients who develop pacing-induced heart failure on an existing leadless pacemaker and require an upgrade to CRT.
Extended experience
The new Australian study extends this experience into de novo heart failure patients who require CRT. These patients will receive both a leadless pacemaker and the WiSE System. De novo cases account for about 75% of the global CRT market, and EBR sees this indication as a pathway to significantly expanding its total addressable market and positioning WiSE as a potential first-line CRT option.
EBR Systems president and CEO John McCutcheon said the first implant under TLC-AU marked an important strategic step.
“The first implant in the TLC-AU study is a significant milestone for EBR, marking our entry into the much larger frontline CRT market,” McCutcheon said. “TLC-AU allows us to build on the FDA-labelled upgrade indication and generate the evidence needed to position WiSE CRT as a fully leadless alternative for patients requiring resynchronisation therapy. As leadless pacing rapidly becomes standard of care, advancing a totally leadless CRT solution strengthens EBR’s leadership in the next major evolution of heart-failure treatment.”
Principal Investigator Dr Paul Gould said the team at Princess Alexandra Hospital was pleased to contribute to the first case in the program.
“It was a privilege to lead the team completing the first Totally Leadless CRT implant in this feasibility study,” Dr Gould said. “The team at Princess Alexandra Hospital was proud to contribute to this important milestone and to support the evaluation of a totally leadless cardiac resynchronisation option for heart failure patients. We believe this study will provide valuable insights into the role that Totally Leadless CRT may play in expanding treatment options for suitable patients in the future.”
About TLC-AU
Sponsored by EBR Systems, TLC-AU is a single-arm, prospective, multi-centre feasibility study. The company plans to enrol 20–40 patients across up to five Australian centres, including both de novo CRT patients and those being upgraded from an existing intracardiac pacemaker.
Participants will be followed for six months.
The primary objective is to assess the safety and efficacy of co-implanting the WiSE CRT System with an intracardiac pacemaker to deliver totally leadless CRT.
A secondary objective is to evaluate clinical response to totally leadless CRT at six months compared with baseline.