Late-breaking data show reliable performance of small-diameter defibrillation lead, the Medtronic OmniaSecure™
Medtronic announced positive results from the LEADR Pivotal Trial of its investigational OmniaSecure™ defibrillation lead, which met primary safety and effectiveness endpoints. Presented at Heart Rhythm 2024 and published in Heart Rhythm journal, the study showed a 97.5% success rate in defibrillation testing and a 97.1% complication-free rate at six months, exceeding the prespecified goals of 88% and 90%, respectively. The OmniaSecure lead, the smallest transvenous defibrillation lead, demonstrated zero fractures within 12 months and a 97.9% implant success rate. The trial involved 675 patients across 17 countries. Medtronic aims to present additional reliability data soon and has initiated the LEADR LBBAP study to evaluate the lead in Left Bundle Branch Area Pacing.
- LEADR Pivotal Trial met primary safety and effectiveness endpoints.
- 97.5% success rate in defibrillation testing exceeded the goal of 88%.
- 97.1% of patients were free from lead-related major complications at six months, surpassing the 90% goal.
- Zero lead fractures observed through an average follow-up of 12.7 months.
- 97.9% implant success rate achieved.
- The OmniaSecure lead is the smallest transvenous defibrillation lead globally (4.7 French).
- Medtronic plans to present more reliability data from the LEADR study.
- Initiation of the LEADR LBBAP study for further evaluation.
- The OmniaSecure defibrillation lead is still investigational and not approved for sale or distribution.
- Potential risks and complications associated with new medical device technologies.
Insights
The primary results from the LEADR Pivotal Trial indicating that the OmniaSecure™ defibrillation lead met and exceeded its safety and effectiveness endpoints have significant implications. The high success rate in defibrillation testing (97.5%) and the low incidence of lead-related major complications (97.1% complication-free at six months) suggests that this new lead could offer a safer option compared to existing defibrillation leads. The reduced diameter (4.7 French) minimizes risks such as venous occlusion and tricuspid valve complications often associated with larger leads. These advancements could not only improve patient outcomes but also position Medtronic as a leader in innovation within the cardiac device market.
From an investor's perspective, these clinical results underscore Medtronic's ability to push the envelope in medical technology and suggest a strong pipeline for future product approvals, potentially driving higher market penetration and revenue growth in the long term. However, since OmniaSecure is still investigational and not yet approved for sale, the immediate financial impact is limited, though the outlook remains highly positive.
For retail investors, understanding the market implications of the LEADR trial results is crucial. The successful outcomes highlight Medtronic's ongoing commitment to innovation and its ability to meet stringent regulatory and clinical benchmarks. In the highly competitive cardiac device market, the OmniaSecure lead's smaller size and improved reliability could differentiate Medtronic's offerings from those of competitors like Boston Scientific and Abbott Laboratories.
The clinical success of OmniaSecure also sets a strong foundation for regulatory approval, which could significantly enhance Medtronic's market share in the ICD segment. The company's deep experience in cardiac devices and its robust R&D capabilities, as demonstrated by the successful adaptation of the SelectSecure™ Model 3830 pacing lead for defibrillation purposes, further solidifies investor confidence in its long-term growth prospects.
However, investors should remain aware of potential regulatory hurdles and market adoption rates, which could influence the time frame for realizing financial gains from this innovation.
The financial implications of the LEADR trial's positive results are multi-faceted. Medtronic's ability to showcase a product that exceeds both safety and effectiveness goals positions the company for a potential increase in market value. The zero lead fractures reported and the high implant success rate (97.9%) serve as strong indicators of product reliability, which could translate into long-term financial stability and revenue growth.
For investors, these results signal that Medtronic is likely to continue its trajectory of innovation-driven growth. The company's proactive approach in beginning studies like LEADR LBBAP also indicates a forward-looking strategy, aiming to diversify its product applications and enhance its market reach. However, it's important to note that the OmniaSecure lead is not yet commercially available, so while the long-term outlook appears promising, the immediate financial impact will be more subdued.
Investors should watch for further announcements related to regulatory approvals and market introduction timelines, as these will be critical milestones influencing Medtronic's stock performance.
Global LEADR clinical trial meets safety and effectiveness objectives; results presented at Heart Rhythm 2024 and simultaneously published in Heart Rhythm
Implantable cardioverter defibrillators (ICDs) are the gold standard for preventing sudden cardiac death. Yet transvenous defibrillator leads, which are thin wires connected to the ICD and threaded through the veins into the heart muscle, remain the weakest point of the system,1 given the harsh environment inside the human body where the lead must remain attached and yet flex with millions of heart contractions over a patient's lifetime. Existing defibrillation leads have a large diameter (7-8 French), which can contribute to venous occlusion or tricuspid valve complications. For patients where an extravascular defibrillator may not be appropriate, Medtronic engineers designed the OmniaSecure defibrillation lead based on the Medtronic SelectSecure™ Model 3830 pacing lead, which has offered safe and effective treatment to patients for more than 20 years. By beginning with this highly reliable pacing lead and building a larger lead suitable for defibrillation therapy, the Medtronic OmniaSecure lead is the world's smallest transvenous defibrillation lead (4.7 French, equivalent to the diameter of graphite in a wooden pencil).
LEADR Primary Results: Effectiveness
Defibrillation testing conducted at device implantation in 119 patients was successful in
LEADR Primary Results: Safety
At six months,
"The positive results from the LEADR Pivotal trial 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," said George H. Crossley, M.D., Director of the Electrophysiology Lab and Cardiac Research Enterprise, Vanderbilt University Medical Center,
The LEADR Pivotal trial is a prospective, multicenter, single-arm, non-randomized, global clinical study that assessed the safety and effectiveness of the Medtronic OmniaSecure defibrillation lead when placed at traditional locations in the right ventricle to achieve defibrillation, sensing, pacing and cardioversion in patients at risk of sudden cardiac death. The study enrolled 675 patients at 45 sites in 17 countries in North America,
Secondary and Ancillary Results: Reliability
The lead demonstrated reliable performance with zero (0) study lead fractures through an average follow up of 12.7±4.8 months. Medtronic developed and validated an in-vitro model that accurately predicts lead reliability out to 10 years,2 and then applied that model within the study to predict a fracture-free survival of
Nearly
Medtronic plans to present additional reliability model results from the LEADR study in the coming months.
"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, which is part of the Cardiovascular Portfolio at Medtronic. "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."
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. First implants were recently conducted by Muhammad Afzal, M.D., MBBS, principal investigator at The Ohio State Medical Center Wexner Medical Center, and John Zakaib, M.D., principal investigator at Minneapolis Heart Institute Foundation.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 | Swerdlow CD, Kalahasty G, Ellenbogen KA. Implantable Cardiac Defibrillator Lead Failure and Management. J Am Coll Cardiol 2016;67:1358-1368 |
2 | Wilkoff, Bruce L., et al. In vitro modeling accurately predicts cardiac lead fracture at 10 years. Heart Rhythm 18.9 (2021): 1605-1612. |
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FAQ
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