Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure™ lead and announces investigational clinical study results
Medtronic (NYSE: MDT) has received FDA approval for its OmniaSecure™ defibrillation lead, the world's smallest defibrillation lead at 4.7 French (1.6mm). The device is approved for right ventricle placement in adults and pediatric patients aged 12 and up.
The lead, built on the SelectSecure™ Model 3830 pacing lead platform, connects to implantable defibrillators to treat life-threatening heart rhythm conditions. The company also presented investigational study results at Heart Rhythm 2025, showing 100% defibrillation success when the lead is implanted in the left bundle branch (LBB) area.
The LEADR LBBAP clinical study demonstrated a 95.8% successful implantation rate in the first 193 patients, with no procedure-related major complications. The study enrolled approximately 300 patients across 24 sites in 11 countries. The smaller diameter aims to reduce complications such as venous occlusion and tricuspid valve regurgitation.
Medtronic (NYSE: MDT) ha ottenuto l'approvazione dalla FDA per il suo catetere defibrillatore OmniaSecure™, il catetere defibrillatore più piccolo al mondo con un diametro di 4,7 French (1,6 mm). Il dispositivo è approvato per il posizionamento nel ventricolo destro in pazienti adulti e pediatrici di età pari o superiore a 12 anni.
Il catetere, basato sulla piattaforma del catetere di stimolazione SelectSecure™ Modello 3830, si collega a defibrillatori impiantabili per trattare condizioni di ritmo cardiaco potenzialmente letali. L'azienda ha inoltre presentato i risultati di uno studio sperimentale al congresso Heart Rhythm 2025, mostrando un successo del 100% nella defibrillazione quando il catetere viene impiantato nell'area del fascio di His sinistro (LBB).
Lo studio clinico LEADR LBBAP ha dimostrato un tasso di impianto riuscito del 95,8% nei primi 193 pazienti, senza complicazioni maggiori correlate alla procedura. Lo studio ha coinvolto circa 300 pazienti in 24 centri di 11 paesi. Il diametro ridotto mira a ridurre complicazioni come l'occlusione venosa e la rigurgitazione della valvola tricuspide.
Medtronic (NYSE: MDT) ha recibido la aprobación de la FDA para su electrodo de desfibrilación OmniaSecure™, el electrodo de desfibrilación más pequeño del mundo con 4,7 French (1,6 mm). El dispositivo está aprobado para su colocación en el ventrículo derecho en pacientes adultos y pediátricos de 12 años en adelante.
El electrodo, basado en la plataforma del electrodo de estimulación SelectSecure™ Modelo 3830, se conecta a desfibriladores implantables para tratar condiciones de ritmo cardíaco potencialmente mortales. La empresa también presentó resultados de un estudio experimental en Heart Rhythm 2025, mostrando un 100% de éxito en desfibrilación cuando el electrodo se implanta en el área del haz de His izquierdo (LBB).
El estudio clínico LEADR LBBAP demostró una tasa de implantación exitosa del 95,8% en los primeros 193 pacientes, sin complicaciones mayores relacionadas con el procedimiento. El estudio incluyó aproximadamente 300 pacientes en 24 centros de 11 países. El diámetro más pequeño busca reducir complicaciones como la oclusión venosa y la regurgitación de la válvula tricúspide.
Medtronic (NYSE: MDT)가 세계에서 가장 작은 4.7 French(1.6mm) 크기의 OmniaSecure™ 제세동 리드에 대해 FDA 승인을 받았습니다. 이 장치는 12세 이상 성인 및 소아 환자의 우심실에 삽입하는 것이 승인되었습니다.
SelectSecure™ 모델 3830 페이싱 리드 플랫폼을 기반으로 제작된 이 리드는 생명을 위협하는 심장 리듬 문제를 치료하기 위해 이식형 제세동기와 연결됩니다. 회사는 또한 Heart Rhythm 2025에서 임상 연구 결과를 발표했으며, 좌측 방실속(LBB) 부위에 리드를 삽입했을 때 100% 제세동 성공률을 보였습니다.
LEADR LBBAP 임상 연구에서는 첫 193명의 환자 중 95.8%가 성공적으로 리드를 삽입했으며, 시술 관련 주요 합병증은 없었습니다. 이 연구는 11개국 24개 기관에서 약 300명의 환자를 대상으로 진행되었습니다. 작은 직경은 정맥 폐색 및 삼첨판 역류와 같은 합병증을 줄이는 데 목적이 있습니다.
Medtronic (NYSE : MDT) a obtenu l'approbation de la FDA pour son cathéter de défibrillation OmniaSecure™, le plus petit cathéter de défibrillation au monde avec un diamètre de 4,7 French (1,6 mm). L'appareil est approuvé pour une implantation dans le ventricule droit chez les patients adultes et pédiatriques âgés de 12 ans et plus.
Ce cathéter, basé sur la plateforme de cathéter de stimulation SelectSecure™ Modèle 3830, se connecte aux défibrillateurs implantables pour traiter des troubles du rythme cardiaque potentiellement mortels. La société a également présenté les résultats d'une étude expérimentale lors du congrès Heart Rhythm 2025, montrant un taux de succès de défibrillation de 100 % lorsque le cathéter est implanté dans la zone du faisceau de His gauche (LBB).
L'étude clinique LEADR LBBAP a démontré un taux d'implantation réussi de 95,8 % chez les 193 premiers patients, sans complications majeures liées à la procédure. L'étude a inclus environ 300 patients répartis dans 24 centres de 11 pays. Le diamètre réduit vise à diminuer les complications telles que l'occlusion veineuse et la régurgitation de la valve tricuspide.
Medtronic (NYSE: MDT) hat die FDA-Zulassung für seine OmniaSecure™ Defibrillator-Elektrode erhalten, die mit 4,7 French (1,6 mm) die kleinste Defibrillator-Elektrode der Welt ist. Das Gerät ist für die Platzierung im rechten Ventrikel bei Erwachsenen und pädiatrischen Patienten ab 12 Jahren zugelassen.
Die Elektrode basiert auf der SelectSecure™ Modell 3830 Stimulationsplattform und wird an implantierbare Defibrillatoren angeschlossen, um lebensbedrohliche Herzrhythmusstörungen zu behandeln. Das Unternehmen stellte außerdem Ergebnisse einer Studie auf dem Heart Rhythm 2025 vor, die eine 100%ige Defibrillationsrate bei Implantation im linken Tawara-Schenkel (LBB) zeigte.
Die LEADR LBBAP-Studie zeigte eine Erfolgsrate von 95,8% bei den ersten 193 Patienten ohne schwerwiegende verfahrensbedingte Komplikationen. Die Studie umfasste etwa 300 Patienten an 24 Standorten in 11 Ländern. Der kleinere Durchmesser soll Komplikationen wie Venenverschluss und Trikuspidalklappeninsuffizienz verringern.
- FDA approval received for world's smallest defibrillation lead
- 100% defibrillation success rate in LBB area clinical trials
- 95.8% successful implantation rate in initial 193 patients
- No procedure-related major complications reported in trials
- Potential to reduce downstream complications due to smaller size
- LBB area application still requires FDA approval
- to patients 12 years and older
Insights
Medtronic's FDA-approved OmniaSecure lead offers groundbreaking size reduction with perfect clinical trial results, addressing key complications in cardiac defibrillation therapy.
The FDA approval of Medtronic's OmniaSecure defibrillation lead marks a significant advancement in implantable cardiac device technology. At just
The engineering strategy behind OmniaSecure is particularly noteworthy - building upon the highly reliable SelectSecure Model 3830 pacing lead platform with over 20 years of clinical implementation. This provides an established foundation for reliability while introducing transformative miniaturization.
The concurrent LEADR LBBAP study results are remarkably strong. The
The left bundle branch area placement investigation represents potential paradigm shift in cardiac pacing. Traditional right ventricular pacing can create electrical and mechanical dyssynchrony, whereas LBB pacing could enable more physiologic stimulation by engaging the heart's natural conduction system. If approved for this indication, the OmniaSecure lead could address longstanding limitations in cardiac rhythm management.
The technology's versatility across both traditional and investigational placements demonstrates Medtronic's forward-thinking approach to solving complex cardiac rhythm challenges while maintaining compatibility with existing ICD and CRT-D systems.
Medtronic strengthens cardiovascular portfolio with FDA-approved smallest defibrillation lead and promising clinical data for expanded indication.
Medtronic's FDA approval for the OmniaSecure defibrillation lead represents a strategically significant expansion of their cardiac rhythm management portfolio. This regulatory milestone enables immediate commercialization of a differentiated product that addresses specific clinical needs while leveraging their established SelectSecure technology platform.
The innovation approach is particularly capital-efficient – building upon 20+ years of clinical experience with the SelectSecure Model 3830 pacing lead while introducing meaningful technological advancement with the world's smallest defibrillation lead diameter. This approach typically optimizes R&D investment while accelerating physician adoption through familiarity with the delivery platform.
The expanded patient population including adolescents ages 12+ broadens the addressable market, particularly among patients with smaller anatomies who previously had options. The technology's smaller profile (
The investigational LEADR LBBAP study results strengthen Medtronic's competitive positioning with
The dual development pathway (immediate commercialization for right ventricular placement while pursuing investigational left bundle branch area indication) exemplifies effective pipeline management. This creates both near-term revenue opportunity and potential future market expansion through physiologic pacing capabilities that could differentiate Medtronic's offerings in the highly competitive cardiac rhythm management segment.
Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle
Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success
GALWAY,
Separately, the company is also studying placing the novel, small-diameter OmniaSecure defibrillation lead in the left bundle branch (LBB) area, which has the potential to enable physiologic pacing to more closely mimic the heart's natural conduction system. Investigational outcomes of this study were presented at Heart Rhythm 2025 in
Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are the standard for preventing sudden cardiac death. The ICD/CRT-D connects to a defibrillation lead (insulated electrical wire) that forms the electrical conduit between the device and the heart. The lead senses the heartbeat, and transmits signals to the implanted device, which then delivers therapy to correct or interrupt abnormally fast rhythms. The lead must flex with millions of heart contractions over a lifetime.
Existing defibrillation leads are larger in diameter than the OmniaSecure lead. A larger-diameter lead may increase the potential for downstream complications, such as venous occlusion or tricuspid valve regurgitation.
"FDA approval for the OmniaSecure defibrillation lead furthers our ability to offer physicians and patients a transvenous solution designed to be smaller to help minimize complications−including vascular complications and valve interaction−with strong, reliable lead durability. We engineered the OmniaSecure lead based on the trusted SelectSecure Model 3830 pacing lead, which has been the lead of choice for many physicians for more than 20 years," said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "This milestone underscores our commitment to driving clinical innovations that help patients today while paving the way for future innovations that will usher in the next era of electrophysiology."
Previously, researchers presented late breaking data from the global Lead Evaluation for Defibrillation and Reliability (LEADR) Pivotal Trial showing the OmniaSecure defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals when placed within the right ventricle. The results were presented during Heart Rhythm 2024, simultaneously published in Heart Rhythm, and are the basis of FDA approval for the traditional right ventricular lead placement indication.
Late-Breaking LEADR LBBAP Results Presented at Heart Rhythm 2025
Researchers presented late-breaking results at Heart Rhythm 2025 for the LEADR LBBAP (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing) study that showed the OmniaSecure defibrillation lead demonstrated high defibrillation success when placed in the LBB area for patients indicated for an ICD or CRT-D. Placing the defibrillation lead in the LBB area is being evaluated as an alternative to right ventricular stimulation for sensing, pacing, cardioversion and defibrillation.
Defibrillation testing conducted in 162 patients at device implantation was successful in
"The left bundle branch area is emerging as an option for more physiologic pacing for patients who receive an ICD or CRT-D to treat dangerous heart rhythms," said Pugazhendhi Vijayaraman, M.D., cardiac electrophysiologist at Geisinger Wyoming Valley Medical Center in
The LEADR LBBAP trial is a global, prospective, non-randomized, multi-center study. The study has enrolled approximately 300 patients at 24 sites in 11 countries in
About Medtronic
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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.
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FAQ
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