Boston Scientific Receives FDA Approval for Expanded Indication of INGEVITY™+ Pacing Leads to Include Conduction System Pacing of the Left Bundle Branch Area
Boston Scientific (NYSE: BSX) has received FDA approval to expand the indication for its INGEVITY™+ Pacing Leads to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA). This expansion allows for an alternative to traditional right ventricular pacing in treating symptomatic bradycardia. The LBBA pacing approach may promote greater ventricular synchrony and reduce long-term heart failure risk.
The approval was supported by data from the INSIGHT-LBBA study, involving approximately 400 patients. The INGEVITY+ Pacing Lead, which received initial FDA approval in 2019, features a stylet-driven design for precise positioning and continuous pacing and impedance monitoring capabilities.
Boston Scientific (NYSE: BSX) ha ricevuto l'
L'approvazione è stata supportata da dati dello studio INSIGHT-LBBA, che ha coinvolto circa 400 pazienti. La sonda di pacing INGEVITY+, che ha ricevuto l'approvazione iniziale della FDA nel 2019, presenta un design a stiletto per un posizionamento preciso e capacità di monitoraggio continuo del pacing e dell'impedenza.
Boston Scientific (NYSE: BSX) ha recibido la aprobación de la FDA para expandir la indicación de sus electrodos de estimulación INGEVITY™+ para incluir la estimulación del sistema de conducción (CSP) y la detección del área de la rama izquierda (LBBA). Esta expansión permite una alternativa a la estimulación ventricular derecha tradicional en el tratamiento de la bradicardia sintomática. El enfoque de estimulación LBBA puede promover una mayor sincronía ventricular y reducir el riesgo de insuficiencia cardíaca a largo plazo.
La aprobación se apoyó en datos del estudio INSIGHT-LBBA, que involucró aproximadamente a 400 pacientes. El electrodo de estimulación INGEVITY+, que recibió la aprobación inicial de la FDA en 2019, presenta un diseño de estilete para un posicionamiento preciso y capacidades de monitoreo continuo de estimulación e impedancia.
보스턴 사이언티픽(Boston Scientific, NYSE: BSX)은 FDA 승인을 받아 INGEVITY™+ 페이싱 리드의 적응증을 전도 시스템 페이싱(CSP) 및 좌측 가지 엽역(LLBA)의 감지를 포함하도록 확대했습니다. 이 확장은 증상성 서맥 치료에 있어 전통적인 우심실 페이싱에 대한 대안을 제공합니다. LBBA 페이싱 접근법은 심실 동기화를 증진시킬 수 있으며, 장기적인 심부전 위험을 줄일 수 있습니다.
이번 승인은 약 400명의 환자가 참여한 INSIGHT-LBBA 연구의 데이터를 통해 지원되었습니다. 2019년에 FDA의 최초 승인을 받은 INGEVITY+ 페이싱 리드는 정밀한 위치 지정을 위한 스타일렛 기반 디자인과 지속적인 페이싱 및 임피던스 모니터링 기능을 특징으로 합니다.
Boston Scientific (NYSE: BSX) a reçu l'
L'approbation a été soutenue par des données de l'étude INSIGHT-LBBA, impliquant environ 400 patients. L'électrode de stimulation INGEVITY+, qui a reçu l'approbation initiale de la FDA en 2019, présente un design à stylet permettant un positionnement précis et des capacités de surveillance continue du pacing et de l'impédance.
Boston Scientific (NYSE: BSX) hat die FDA-Zulassung erhalten, um die Indikation für seine INGEVITY™+ Schrittmacherleitungen auf Konduktionssystem-Pacing (CSP) und die Sensibilisierung des linken Schenkelbereichs (LBBA) zu erweitern. Diese Erweiterung ermöglicht eine Alternative zur traditionellen Pacing des rechten Ventrikels zur Behandlung der symptomatischen Bradykardie. Der LBBA-Pacing-Ansatz kann größere ventrikuläre Synchronität fördern und das Risiko einer langfristigen Herzinsuffizienz verringern.
Die Genehmigung wurde durch Daten der INSIGHT-LBBA-Studie unterstützt, an der ungefähr 400 Patienten beteiligt waren. Die INGEVITY+ Schrittmacherleitung, die 2019 die erste FDA-Zulassung erhielt, verfügt über ein stylet-gesteuertes Design für eine präzise Positionierung sowie über kontinuierliche Pacing- und Impedanzüberwachungsfunktionen.
- FDA approval for expanded indication of INGEVITY™+ Pacing Leads
- Potential for improved patient outcomes with LBBA pacing approach
- Expanded market opportunity in the growing field of conduction system pacing
- Strengthened competitive position in cardiac rhythm management
- None.
Insights
The FDA's expanded indication for Boston Scientific's INGEVITY™+ Pacing Leads is a significant development in cardiac rhythm management. This approval allows for conduction system pacing (CSP) of the left bundle branch area (LBBA), offering an alternative to traditional right ventricular pacing. The potential benefits include:
- Greater ventricular synchrony
- Reduced long-term risk of heart failure
- Enhanced implant experience for physicians
The approval is backed by data from 400 patients in the INSIGHT-LBBA study, demonstrating safety and efficacy. This expansion aligns with the growing trend towards LBBA pacing, potentially broadening the market for Boston Scientific's cardiac devices.
This FDA approval strengthens Boston Scientific's position in the cardiac rhythm management market. Key financial implications include:
- Market expansion: Potential increase in addressable patient population
- Competitive advantage: Early mover in LBBA-specific tools and resources
- Revenue growth: Possible boost in sales of INGEVITY+ Pacing Leads and related products
While specific financial projections aren't provided, this approval could drive long-term growth in Boston Scientific's Cardiac Rhythm Management segment. Investors should monitor upcoming quarterly reports for indications of revenue impact from this expanded indication.
Pacing of the LBBA is an alternative to traditional right ventricular pacing for the treatment of symptomatic bradycardia, a condition in which the heart beats too slowly. Through this pacing approach, which uses the heart's natural electrical system, a lead is placed in the LBBA of the heart's conduction system. This technique may promote greater ventricular synchrony and reduce the long-term risk of heart failure associated with traditional right ventricular pacing.1
"This approval strengthens our broader initiative to provide physicians with LBBA-specific tools and educational resources, while reinforcing our commitment to developing safe and effective pacing technologies," said Scott Olson, senior vice president and president, Cardiac Rhythm Management and Diagnostics, Boston Scientific. "We believe the expanded indication for the INGEVITY+ Pacing Lead will enhance the implant experience for physicians and connect this technology to the growing number of patients who can benefit from LBBA pacing."
Clinical evidence submitted to the FDA to support the expanded indication included data from approximately 400 patients from the INSIGHT-LBBA study – an analysis of INGEVITY+ pacing leads that were previously implanted in the LBBA for anti-bradycardia pacing – and supplemented with bench testing and LATITUDE™ Programming System data.
"This expanded indication provides physicians using the INGEVITY+ Pacing Lead the flexibility to determine the most appropriate pacing strategy based on individual patient characteristics," said Kenneth Stein, M.D., senior vice president and global chief medical officer, Boston Scientific. "Data has demonstrated this lead to be safe and effective for LBBA pacing – a rapidly growing pacing technique – allowing us to provide a new therapeutic option on a proven lead that will further the quality of patient care."
The INGEVITY+ Pacing Lead is driven by a stylet during lead placement, which supports positioning the device into a desired location within the heart and allows for both continuous pacing and impedance monitoring – key features that can aid appropriate placement and fixation. The expanded indication follows the launch of the Boston Scientific CSP portfolio – inclusive of the OneLINK™ Splitter Cable, INGEVITY+ Helix Locking Tool and site-selective pacing delivery catheters – which is designed to support the safe and effective placement of the INGEVITY+ Pacing Lead in the LBBA. The INGEVITY+ lead received FDA approval in 2019 for use with pacemakers and defibrillators.
More information on the INGEVITY+ Pacing Lead is available here.
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.
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1 Sharma P et al. Clinical outcomes of left bundle branch area pacing compared to right ventricular pacing: Results from the Geisinger-Rush Conduction System Pacing Registry. Heart Rhythm. 2021; 19:3-11
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FAQ
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