Clinical investigators complete record enrollment in real-world Registry, HEAL (An All-comers Registry of the MicroStent PeripHeral Vascular StEnt in subjects with PeripherAl ArteriaL Disease)
WILMINGTON, Mass., June 19, 2024 /PRNewswire/ -- Micro Medical Solutions -- Micro Medical Solutions, a leader in providing innovative medical device solutions, is excited to announce that it has achieved a major milestone with the enrollment of its 200th patient in the HEAL Registry. This unique registry is focused on gathering real world evidence using its MicroStent technology for treatment of patients with Chronic Limb-Threatening Ischemia (CLTI) and Critical Limb Ischemia (CLI).
CLTI and CLI are debilitating conditions that affect the blood vessels in the legs and feet. Those afflicted with this disease often suffer from severe pain, numbness, and open non-healing wounds. Without intervention, these conditions can lead to amputation, loss of mobility, and death. Micro Medical Solutions is committed to providing a potential solution for this medically complex and underserved patient population.
The HEAL Registry, enrolling patients at ten sites in EU countries, including Italy, Germany, Belgium, Austria and the Netherlands, is crucial clinical research in evaluating the use of MMS' MicroStent to treat real world patients afflicted with CLI/CLTI. HEAL's research endpoints provide real world evidence of the effectiveness and safety of treatment with the Micro Stent. With enrollment of 200 patients, the registry has reached a significant clinical and research milestone. The registry is also collecting specific data outcomes in below-the-ankle treatment, specific to wound healing. This data will be reported alongside MMS' US IDE study data to the FDA in its premarket approval application (PMA).
"We are proud to have created the largest real-world cohort of patients and data collection for an implanted stent below the knee in the HEAL Registry," said Greg Sullivan, CEO of Micro Medical Solutions. "This milestone is a testament to our commitment to providing innovative solutions for those suffering from CLI/CLTI. We are optimistic about the encouraging data that has emerged from the registry and look forward to utilizing this information to continue providing effective treatment options."
Micro Medical Solutions completed enrollment in its STAND IDE study, a Randomized Controlled Trial, in the US in December of 2023. MMS expects to share this data in early 2025. STAND reflects controlled patient selection with required follow up visits, HEAL reflects general CLI/CLTI patient population treated in everyday practice while including required follow-up. The combination of RCT and RWE data will provide physicians with the opportunity and confidence to make treatment decisions using evidence-based medicine.
MMS is dedicated to making a positive impact on the lives of those affected by this limb threatening disease and is committed to using real world data to support its mission to support physicians in their management of these patients.
Thank you to the physicians and patients for their continued support as we strive towards providing effective and innovative solutions for those in need.
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