01:00 PM EDT, 05/17/2024 (MT Newswires) -- Medtronic ( MDT ) said Friday its investigational OmniaSecure small-diameter defibrillation lead achieved the primary safety and efficacy endpoints in a pivotal trial.

In terms of safety, Medtronic ( MDT ) said 97.1% of the 657 patients with an implant did not suffer lead-related major complications at six months, exceeding the 90% prespecified safety performance goal.

The company also said the defibrillation testing conducted at device implantation was successful for 97.5% of 119 patients, surpassing the 88% prespecified efficacy goal.

Additional reliability model results from the study will be presented in the coming months, Medtronic ( MDT ) said. The study covered 675 patients at 45 sites in 17 countries in North America, Europe, Asia, and Australia, the company added.

OmniaSecure is the world's smallest transvenous defibrillation lead, with a diameter of 4.7 French equivalent to graphite in a wooden pencil, Medtronic ( MDT ) said.

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