Boston Scientific Reports the US FDA’s Expanded Approval of INGEVITY+ Pacing Leads for Conduction System Pacing
Shots:
- The US FDA has agreed to expand the indication of current-generation INGEVITY+ Pacing Leads to conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single or dual-chamber pacemaker
- The approval was based on results from INSIGHT-LBBA trial, involving 400 subjects, that examined INGEVITY+ pacing leads that had previously been implanted in the LBBA for anti-bradycardia pacing. It was supplemented by bench testing & LATITUDE Programming System data
- The INGEVITY+ Pacing Lead is assisted by a stylet, facilitating the device's positioning into the required location within the heart plus enables continuous pacing and impedance monitoring
Ref: Boston Scientific | Image: Boston Scientific
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