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Medtronic’s OmniaSecure Lead Shows Promise in Sudden Cardiac Death Prevention

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Safety and efficacy of the Medtronic OmniaSecure defibrillation lead’s evaluation is crucial for advancing treatment options for patients at risk of sudden cardiac death. This innovative device has the potential to significantly improve outcomes for patients, addressing critical challenges associated with current defibrillation technologies.

The global Lead Evaluation for Defibrillation and Reliability (LEADR) Pivotal Trial demonstrated that the OmniaSecure lead met its primary safety and effectiveness endpoints, providing robust evidence of its performance. This trial was a comprehensive study that involved multiple centers and a diverse patient population, ensuring that the results were widely applicable and reliable. The results, which were presented as late-breaking clinical data at the Heart Rhythm Society (HRS) 2024 Annual Meeting and published in the prestigious journal Heart Rhythm, show that this investigational lead exceeded prespecified performance goals.

These findings underscore the OmniaSecure lead’s potential to set a new standard in the prevention of sudden cardiac death, offering a promising alternative to existing therapies. The success of the OmniaSecure lead in the LEADR trial marks a significant milestone in the development of more effective and safer treatments for patients at risk of sudden cardiac death.

OmniaSecure Lead Achieves High Success in LEADR Trial; Medtronic Seeks FDA Approval

Defibrillation testing during device implantation was successful in 97.5% of cases among 119 patients, surpassing the prespecified efficacy goal of 88%. At six months, 97.1% of the 657 patients with an implant attempt were free from lead-related major complications, exceeding the safety performance goal of 90%. Notably, no lead-related major complications occurred between six and twelve months.

The OmniaSecure defibrillation lead, based on the Medtronic SelectSecure Model 3830 pacing lead, is the smallest transvenous defibrillation lead (4.7 French) globally. This innovative design aims to mitigate issues associated with larger-diameter leads, such as venous occlusion and tricuspid valve complications. The LEADR trial, which included 675 patients across 45 sites in 17 countries, demonstrated zero lead fractures through an average follow-up of 12.7 months. Nearly 12% of patients received appropriate therapy for dangerous ventricular arrhythmias within 14 months. Anti-tachycardia pacing (ATP) terminated 74.9% of episodes, preventing shocks in 49 patients. These results underscore the OmniaSecure lead’s reliability and effectiveness in delivering life-saving therapy.

Sudden Cardiac Death

Medtronic has filed for FDA approval of the OmniaSecure lead, which remains investigational and not yet approved for sale. The company also initiated the LEADR LBBAP study, evaluating the lead’s performance when placed at the Left Bundle Branch Area in patients eligible for ICD or LOT-CRT. This study aims to assess whether left bundle branch pacing can be a viable alternative to right ventricular stimulation.

Positive LEADR Trial Results for Sudden Cardiac Death Prevention

“Medtronic has a long history of bringing innovative, life-saving technologies to patients,” said Alan Cheng, M.D., chief medical officer of Medtronic’s Cardiac Rhythm Management business. “The LEADR study results are an encouraging step forward in achieving a more reliable defibrillation lead for patients at risk of sudden cardiac death.” Medtronic plans to present additional reliability model results from the LEADR study in the coming months, further solidifying the OmniaSecure lead’s potential to revolutionize the prevention of sudden cardiac death.

The LEADR Pivotal trial was a prospective, multicenter, single-arm, non-randomized global study. It assessed the safety and effectiveness of the OmniaSecure lead when placed at traditional locations in the right ventricle for defibrillation, sensing, pacing, and cardioversion in patients at risk of sudden cardiac death. The study enrolled 675 patients across 45 sites in 17 countries, including the United States, Europe, Asia, and Australia.

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The OmniaSecure lead demonstrated a 97.9% implant success rate and stable electricals through 12 months. Medtronic developed an in-vitro model predicting lead reliability out to 10 years, showing a fracture-free survival rate of 99.9% at two years. These results highlight the lead’s potential to provide reliable therapy over the lifetime of the patient.

New Hope for Sudden Cardiac Death Patients

Medtronic’s LEADR Pivotal trial results are a significant advancement for patients at risk of sudden cardiac death who rely on ICDs to deliver life-saving therapy in the event of a dangerous heart rhythm. The OmniaSecure lead demonstrated exceptional reliability, with zero study lead fractures and a high success rate for defibrillation and pacing. This innovative, low-profile defibrillation lead leverages a highly reliable pacing lead design to help achieve this goal, and the unique catheter-based method of implantation helps the physician place the lead in the optimal position for the patient.

“For 75 years, Medtronic has innovated to bring better life-saving technologies to the patients who need them,” said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business. “Given our history in working with health care providers to design technology for patients with arrhythmias, we applied learnings from our deep experience with both transvenous defibrillation and pacing leads to create the novel OmniaSecure lead, a catheter-delivered lead that can be placed in the desired location. The LEADR study results are an encouraging step forward in achieving the goal of an even more reliable defibrillation lead for patients.”

The Future of Defibrillation Technology

In addition to the LEADR results presented at Heart Rhythm 2024, Medtronic recently initiated the LEADR LBBAP study (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing), which is assessing the safety and efficacy of the investigational OmniaSecure defibrillation lead when placed at the Left Bundle Branch Area in patients eligible for an ICD or Left Bundle Branch-Optimized Cardiac Resynchronization Therapy (LOT-CRT). Placing the defibrillation lead in the left bundle branch area is being evaluated as an alternative to right ventricular stimulation for sensing, pacing, cardioversion, and defibrillation.


Resource: Medtronic, May 17, 2024

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