Future Pathway
Compatibility with Avinger’s Existing Imaging Console
Lumivascular’s Tigerheart™ is also compatible with an already commercially available imaging console, significantly reducing the technical and regulatory risk of the program. The fundamental mechanism of action of Tigerheart™ has also been proven through the CTO crossing devices developed, successfully evaluated for safety and efficacy in a 100-patient clinical trial, and commercialized by the founding team for use in the peripheral vasculature while at Avinger, as evidenced by $40M+ in cumulative revenues of these products, potentially also reducing the clinical and commercialization risk for Tigerheart™.
Clinical Trial Design
Based on an IDE pre-submission process completed with the FDA, the company will conduct a 110-patient clinical trial at up to 15 sites evaluating Tigerheart™ in the safe and effective crossing of coronary CTOs. The primary efficacy endpoint is technical success, defined as the ability to successfully facilitate placement of a guidewire beyond the CTO into the distal true lumen. Patients will only require follow-up to assess 30-day major adverse cardiac event (or MACE) rate, which also represents the primary safety endpoint. The company expects the duration of enrollment and follow-up to take approximately 1 year. However, we have indicated to the FDA that we will perform an interim analysis of the first 83 patients after 30-day follow-up to assess if technical success and MACE have a statistically significant p value to warrant early completion of the trial, potentially accelerating the timeline.
Timeline and Milestones (Including Progress Made in a
Pre-Existing Coronary CTO Program)
