Micro Medical Solutions Provides Updates on MicroStent European Registry and US IDE Trial

June 19, 2024—Micro Medical Solutions announced updates on its European HEAL postmarket registry and its United States STAND investigational device exemption (IDE) randomized controlled trial. The studies are evaluating the company’s MicroStent technology in the treatment of patients with chronic limb-threatening ischemia (CLTI)/critical limb ischemia (CLI).

According to the company, HEAL—“an all-comers observational study of the MicroStent peripheral vascular stent system in subjects with peripheral arterial disease”—reflects a general CLTI/CLI patient population treated in everyday practice while including required follow-up. STAND—“a clinical evaluation of the MicroStent peripheral vascular stent in subjects with arterial disease below the knee”—reflects controlled patient selection with required follow-up visits.

The company stated that the HEAL registry is gathering real-world evidence on the safety and effectiveness of the MicroStent technology for treating CLTI/CLI. The registry has enrolled 200 patients at 10 sites in European countries, including Italy, Germany, Belgium, Austria, and the Netherlands.

The HEAL registry is also collecting data specific to wound healing outcomes for below-the-ankle treatment. The data will be reported alongside the company’s United States STAND IDE study data in its premarket approval application to the FDA, noted the company.

In December 2023, Micro Medical Solutions announced completion of enrollment in the STAND IDE study, with data expected to be shared in early 2025, advised Micro Medical Solutions.