Naples Team Pairs Two Leadless Devices in Heart Patient

NCH Rooney Heart Institute combined a Medtronic Micra and EBR WiSE CRT System in a single procedure for a patient with a leaky heart valve.

Updated on Nov. 2, 2026 in Heart Disease

Small sealed cardiac device on a stainless tray beside a coiled catheter in a bright coastal treatment room with a palm frond at the window edge.
Doctors at NCH's Rooney Heart Institute in Naples, Florida, paired a Medtronic Micra and an EBR WiSE CRT System in one patient with a severely leaky heart valve. AI Illustration. Upload story photo >

Doctors at NCH's Rooney Heart Institute in Naples, Florida, implanted a Medtronic Micra pacemaker and an EBR Systems WiSE CRT System at the same time in one patient. The combined procedure was the first time WiSE was implanted simultaneously with a right-sided leadless pacemaker in the United States.

Why it matters

The patient's severely leaky heart valve ruled out conventional pacemakers, which rely on wires threaded through veins. The approach shows how leadless devices can provide synchronized pacing when wired options are not viable.

The procedure followed FDA approval of the WiSE CRT System in April 2025 for certain adults who need CRT and either cannot receive a conventional left-ventricle lead or are considered high risk for one. The stub does not report patient outcomes or follow-up data from this single case.

The players

NCH Rooney Heart Institute

A heart care center within the NCH Healthcare System in Naples, Florida, where the procedure was performed.

Dr. Dinesh Sharma

An electrophysiologist at NCH's Rooney Heart Institute who led the team implanting the two leadless devices.

Medtronic

A global medical technology company that manufactures the Micra leadless pacemaker used in the procedure.

EBR Systems

A medical device company that developed the WiSE CRT System, which paces the left ventricle without wires.

The details

Dr. Dinesh Sharma, an electrophysiologist at NCH's Rooney Heart Institute, led the team that paired a Medtronic Micra in the right ventricle with EBR Systems' WiSE CRT System, which paces the left ventricle. WiSE uses a small electrode inside the left ventricle powered by a separate battery and ultrasound transmitter implanted in the chest, and the combination avoids the wires that connect a traditional pacemaker to the heart.

Timeline

  1. April 2025: FDA approved the WiSE CRT System for certain adults needing CRT.

  2. 2022: Sharma's team reported the first totally leadless CRT system in the U.S.

  3. Mid-2025: The simultaneous WiSE and Micra implant procedure took place in Naples.

Heart Disease Landscape

The combined implant builds on the FDA's April 2025 approval of the EBR Systems WiSE CRT System, which opened the device to adults who cannot receive a conventional left-ventricle lead. It extends a 2022 U.S. first in totally leadless CRT reported by Sharma's team, moving leadless cardiac resynchronization from a single-device step into paired-device use.

Patients with severe valve disease who cannot receive conventional wired pacemakers may have an additional option for synchronized pacing. The approach avoids the wires that connect traditional devices to the heart through veins, which changes what devices and implant procedures are available to qualifying patients.

The takeaway

Leadless devices are expanding the options for patients who cannot tolerate wires, and combining them can address cases that single devices could not. Patients with complex valve disease should discuss device choices with their cardiology team.

Further reading

For more on device-based treatments, explore Heart Disease coverage.

Source note: This article includes information reported by WBBH.