Novel Drug & Emergent Therapeutics | Medical Devices | Cardiology
Boston Scientific Receives FDA Approval for Expanded Indication of INGEVITY™+ Pacing Leads to Include Conduction System Pacing of the Left Bundle Branch Area
Originally published: 17 September 2024
Source: Boston Scientific Corporation Press Release
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDC004
Category: Cardiology
Crossreference: Medical Devices
Category tags: pacemaker leads, Boston Scientific,
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| FDA Approved |
Boston Scientific has received FDA approval to expand the use of its INGEVITY™+ Pacing Leads to include conduction system pacing (CSP) and left bundle branch area (LBBA) sensing when connected to single- or dual-chamber pacemakers.
According to the Press Release, the pacing of the left bundle branch area (LBBA) offers an alternative to traditional right ventricular pacing for treating symptomatic bradycardia. The approach may improve ventricular synchrony and lower the long-term risk of heart failure linked to conventional right ventricular pacing.
The expanded indication is backed by data from the INSIGHT-LBBA study, which evaluated around 400 patients. The study included an analysis of INGEVITY+ pacing leads that were previously implanted in the LBBA for anti-bradycardia pacing, supplemented with bench testing and LATITUDE™ Programming System data.
The lead was originally approved in 2019 for pacemaker and defibrillator use.
Clinical Trials & Supporting Information
| Clinical Study State | ClinicalTrial.gov Registration | Study Name |
|---|---|---|
Access Original Press Release
17 September 2024 | Approval for Expanded Indication of INGEVITY™+ Pacing Leads to Include Conduction System Pacing of the Left Bundle Branch Area
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