1-channel ECG event recorder LUX-Dx II+™

wireless

Overview
The LUX-Dx II+™ Insertable Cardiac Monitor (ICM) System expands the LUX-Dx platform with enhanced dual-stage detection and verification algorithms to reduce false alerts, prioritize clinically actionable events, and support patient adherence. The system provides clear single-lead S‑ECGs and supports remote programming and patient smartphone monitoring via the myLUX Patient App.

How it works
The system uses enhanced dual-stage algorithms (AF, Pause, PVC Burden) with additional verification steps, nightly programming options, and signal-quality advantages to:

• Reduce false positives and lower clinician review workload
• Provide daily PVC burden values and trends with singlet/couplet/triplet detection
• Differentiates nighttime bradycardia and pause events
• Transmit prioritized alerts and S‑ECGs to the LATITUDE Clarity™ Data Management System

Key capabilities and features

• Enhanced AF dual-stage algorithm with repeating sequential pattern verification and episode merging to reduce S‑ECG review volume
• Pause dual-stage algorithm with improved verification to lower false positives from low signal-to-noise
• Programmable PVC Burden algorithm delivering daily burden values and trends; high PPV and good sensitivity for burdens ≥ 10%
• Nighttime programming to detect and differentiate specified nighttime bradycardia and pause events
• High signal quality for clear S‑ECGs and advanced zoom/annotation in LATITUDE Clarity
• Remote programming via LATITUDE Clarity to adjust device settings without clinic visits
• Patient monitoring through the myLUX™ Patient App (uses patient's smartphone) and Clinic Assistant App; supports RhythmCARE™ Assist for automated myLUX setup and connectivity
• Device supplied preloaded in a reloadable single-piece insertion tool for a standardized insertion procedure

Physician and clinic advantages

• Prioritized, clinically actionable alerts to focus clinician review
• Annotation and review tools to increase review efficiency and confidence
• Customizable reporting and EMR integration options
• One-way patient messages to myLUX app for read-only confirmations
• LATITUDE Clarity interface organized for efficient navigation and workflow

Insertion procedure (summary)

• Cut — Tension the skin away from the incision site and cut at the intended angle until the blade is fully inserted.
• Tunnel — At the incision site, insert the tunneling portion of the insertion tool parallel to the skin approximately 8 mm under the surface.
• Rotate — Rotate the insertion tool 180° to create a pocket for device placement.
• Pull back — Hold the base at the incision and retract the plunger until a hard stop or visible indicator confirms placement.
• Insert — Lower the tool close to the skin and fully depress the plunger to release the device into the channel.
• Remove — Pinch the incision site to stabilize the device while removing the insertion tool.

Tools and accessories
The LUX-Dx II+ ICM is supplied with a reloadable all-in-one insertion tool and an incision tool. Additional items include the myLUX Patient Kit, Clinic Assistant mobile device, myLUX mobile device, and an accessory magnet used to initiate device-mobile communication.

Documentation highlights
Clinician-facing spec sheet and product literature provide technical specifications, indications, safety warnings, algorithm descriptions, performance and longevity notes, and clinical references.

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 (projected): 3 years (projected under defined usage scenarios)
• Projected longevity usage scenarios: average 1 auto-detected event per day; average 1 patient-initiated event per month; ≤ 6 months shelf life between manufacture and insertion; PVC Burden disabled for projection
• Notes: At maximum shelf-storage time of 18 months, projected longevity reduced by ~4 months