Introduction
This document summarizes the LUTONIX 014 Drug Coated Balloon PTA Dilatation Catheter, a medical device developed by BD for the treatment of Critical Limb Ischemia (CLI) in Below-the-Knee (BTK) arteries. CLI is a severe condition characterized by pain, non-healing wounds, and a high risk of amputation, affecting millions of patients.
Product Overview
The LUTONIX 014 DCB is an over-the-wire PTA catheter featuring a paclitaxel drug coating on its balloon surface. It is designed for use in smaller arteries, offering mechanical dilation and the potential to reduce restenosis and the need for reinterventions.
Clinical Trial Summary (LUTONIX BTK IDE Trial)
The LUTONIX BTK IDE Trial was a prospective, global, randomized study comparing the LUTONIX 014 DCB against standard Percutaneous Transluminal Angioplasty (PTA). The trial evaluated safety and effectiveness endpoints.
Key Findings:
- Safety: The LUTONIX DCB demonstrated non-inferiority to PTA. Safety profiles were comparable, with low rates of mortality and major adverse limb events.
- Effectiveness: At 6 months, the LUTONIX DCB showed a clinically meaningful improvement in the composite endpoint of limb salvage and primary patency compared to PTA. This early benefit included a longer time to first reintervention. However, these advantages diminished over time, with effectiveness rates converging with PTA by 12 months and beyond. The primary effectiveness endpoint did not meet its pre-specified statistical threshold.
Benefit-Risk Assessment
BD believes the data provide a reasonable assurance of the device's effectiveness and quality of life benefits, particularly in the critical early period post-procedure for CLI patients. The observed safety profile, equivalent to PTA, supports a favorable benefit-risk profile, acknowledging the early effectiveness gains despite the lack of sustained long-term differences.
Conclusion
The LUTONIX 014 DCB is presented as a safe and potentially beneficial option for treating BTK lesions in CLI patients, offering early improvements in revascularization outcomes.
