1-channel ECG event recorder LUX-Dx II™

wireless

Overview
The LUX-Dx II ICM System delivers clear S‑ECG signal quality, targeted alerts, efficient clinic workflows, and patient connectivity. It builds on dual-stage detection and signal processing from the previous generation and adds enhanced algorithms, including a PVC Burden measurement, to reduce false alerts and identify multiple PVC sequence types (singlets, couplets, triplets).

How it works
The LUX-Dx II ICM employs enhanced dual-stage arrhythmia-detection algorithms with verification steps to limit false positives while maintaining clinical sensitivity. Algorithm capabilities include AF, AT, Bradycardia, Pause, Tachycardia and a dedicated PVC Burden measurement. Data transmit to a dedicated data management system tailored for ICM workflows, providing advanced review tools, annotation and zoom, reporting and EMR integration, one-way patient messaging, and remote programming to adjust device settings without an in-clinic visit.

Key features

• High-quality S‑ECG signal with enhanced dual-stage algorithms to reduce false alerts.
• PVC Burden algorithm reporting daily PVC burden percentage and detecting PVC sequences (singlets, couplets, triplets).
• Meaningful alerts across algorithms (AF, AT, Bradycardia, Pause, Tachycardia, PVC Burden).
• Seamless connectivity to a data management system designed for ICM workflows with advanced review and annotation tools.
• Remote programming to adjust device detection parameters remotely.
• Clinic and patient apps: Clinic Assistant app for clinicians and myLUX Patient app for smartphone-based monitoring.
• Option for patients to use their own smartphone with the myLUX Patient app or an optionally provided mobile device.

Insertion procedure (summary)
The LUX-Dx II ICM ships pre-loaded in a reloadable, single-piece insertion tool and uses a straightforward, familiar implant technique for reliable placement and rapid validation. Typical procedural steps include:

• Cut — apply tension on the skin away from the incision, cut at the intended angle until the blade is fully inserted.
• Tunnel — fully insert the tunneling portion of the insertion tool parallel to the skin ~8 mm under the surface at the incision site.
• Rotate — rotate the insertion tool 180° to create a pocket for the device.
• Pull back — hold the base of the insertion tool at the incision site and pull back the plunger until a hard stop or visible indicator confirms device drop into the channel.
• Insert — lower the tool close to the skin and push the plunger completely to release the device.
• Remove — pinch the incision site to hold the device while removing the insertion tool.

Physician and clinic advantages
The system provides enhanced detection with verification steps to reject false positives, separate programmability for AT and AF to improve diagnostic accuracy, and tools to increase clinic efficiency including advanced S‑ECG zoom/annotation, customizable reporting and EMR integration, one-way patient messages, and remote programming to accelerate clinical decision-making.

Patient experience
Patients may use the downloadable myLUX Patient app for smartphone-based monitoring; when using the app, supplemental automated support services assist with setup and connectivity. The solution is designed to support patient compliance while reducing clinic burden.

Representative materials (table)
Spec Sheet available
Product literature and supporting documents
Multiple product literature resources and technical PDFs accompany the device, including spec sheet, reimbursement/billing guides, and indications/safety/warnings documentation.

Technical specifications

• Volume: 1.2 cm3
• Mass: 3 g
• Dimensions (W x H x D): 7.2 mm x 44.8 mm x 4.0 mm
• Surface area of can electrode: 75.3 mm2
• Surface area of header electrode: 10.2 mm2
• Battery longevity: 3 years (projected, see notes)
• Battery longevity notes: 3 years projected under the following usage scenarios: average 1 auto-detected event per day; average 1 patient-initiated event per month; shelf life ≤ 6 months between manufacture and insertion; PVC Burden disabled. At maximum shelf-storage (18 months) projected longevity is reduced by ~4 months.