Texas Cardiac Arrhythmia Institute Becomes First in U.S. to Use FDA-Approved Wireless System for Arrhythmia Treatment

St. David's Medical Center pioneers clinical use of innovative wireless EP solution, marking a new chapter in minimally invasive cardiac care.

The Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center has achieved a significant milestone in cardiac care by becoming the first center in the U.S. to implant a newly FDA-approved, leadless cardiac resynchronization therapy (CRT) system. This next-generation technology delivers synchronized electrical stimulation directly to the heart’s left ventricle using a miniature, wireless device implanted inside the heart tissue. By converting ultrasound energy into targeted electrical pulses, the system improves heart rhythm and pumping efficiency, offering a novel approach for heart failure patients in need of CRT.

Unlike traditional CRT devices that require transvenous leads, this new system eliminates the challenges associated with lead placement, particularly in anatomically difficult or previously ineligible patients. Its leadless design enables more flexible positioning, reduces procedural complexity, and lowers the risk of complications related to lead failure or infection. For patients who had limited or no treatment options due to structural or physiological constraints, this innovation opens the door to life-enhancing therapy, redefining the standard of care in advanced heart rhythm management.

The successful deployment of this technology at TCAI reflects the institute’s leadership in adopting transformative solutions that improve patient outcomes. With a team led by world-renowned electrophysiologist Dr. Andrea Natale and a strong infrastructure supporting complex procedural work, TCAI is well-positioned to lead further clinical integration and research around this system. As adoption grows, the technology is expected to broaden access to CRT globally, offering a safer, more adaptable therapy for managing heart failure and advancing the future of electrophysiological treatment.


MedTech Spectrum's Summary 
 
First-in-Nation Use of Leadless CRT System: The Texas Cardiac Arrhythmia Institute at St. David’s Medical Center is the first U.S. center to implant an FDA-approved wireless device that delivers cardiac resynchronization therapy without the need for leads—expanding treatment options for previously untreatable heart failure patients.
 
Minimally Invasive and Flexible Placement: This miniature, leadless device uses ultrasound energy to deliver electrical stimulation directly to the heart’s left ventricle, offering greater procedural flexibility, reduced risk of complications, and improved rhythm restoration.
 
Advancing the Future of Cardiac Care: The successful deployment underscores TCAI’s leadership in adopting transformative, evidence-based technologies—paving the way for broader access to advanced CRT solutions and setting a new benchmark in heart rhythm disorder treatment.