Allina Health Minneapolis Heart Institute first in Upper Midwest to implant innovative defibrillation lead

“This is an important new concept in transvenous defibrillator leads utilizing a robust and durable design but resulting in a very small lead diameter,” said John Zakaib, MD, cardiac electrophysiologist at Allina Health Minneapolis Heart Institute. “It is incredibly innovative because this new lead is small and flexible, instead of being bulky and stiff like older leads.”

What is the OmniaSecure lead?
Defibrillator leads are implanted in the right ventricle and act as the connection between the heart and the defibrillator. The lead monitors the heart rhythm and alerts the defibrillator to send an electrical charge to the heart when it detects an irregular heartbeat. In the past, those leads were thick and stiff like a cell phone charging cable, but Medtronic’s OmniaSecure defibrillation lead is thin and floppy, similar to a strand of angel hair pasta.

Patient benefits
Because it is thinner and more flexible, the OmniaSecure defibrillation lead reduces the chances of this implantable device causing venous occlusion (blocked or narrowed vein) or tricuspid valve regurgitation (a malfunction of the tricuspid valve causing blood to leak backward between the right upper and lower chambers of the heart).

Partnering in innovation

Medtronic engineered the OmniaSecure defibrillation lead, and the Minneapolis Heart Institute Foundation (MHIF), an independent research organization that partners with the physicians from the Allina Health Minneapolis Heart Institute, was the lead-enroller in the LEADR (Lead Evaluation for Defibrillation Reliability) clinical trial that provided safety and efficacy data for FDA approval of the device.

“We were one of the leading centers in the clinical trials,” said Dr. Zakaib, MHIF researcher and principal investigator in the trial. “It’s been a long road, but it’s been incredibly satisfying to participate in this process because this device is going to help a lot of people. We are confident this new innovation will result in better and safer outcomes for patients in the long term.”

The FDA approved the use of the OmniaSecure defibrillation lead in April 2025. Kristopher Krueger, MD, cardiac electrophysiologist with Allina Health Minneapolis Heart Institute completed the first two post-approval cases in the Upper Midwest on January 7, 2026.

“These leads mark a significant advancement in managing the risk of sudden cardiac arrest,” said Dr. Zakaib.