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 18, 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.
About Micro Medical Solutions
For more about Micro Medical Solutions, visit www.micromedicalsolutions.net. 
SOURCE Micro Medical Solutions

Clinical investigators complete enrollment in the 177 patient, randomized, controlled study, STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee, NCT03477604).
WILMINGTON, Mass., Dec. 6, 2023 /PRNewswire/ — Micro Medical Solutions (MMS), an innovator in the field of microvascular intervention to improve clinical outcomes and quality of life in patients with CLI/CLTI, announced today that it has completed its U.S. pivotal clinical study enrollment evaluating the safety and effectiveness of the MicroStent System compared to the current standard of care, PTA (percutaneous transluminal angioplasty). The MicroStent System has already obtained CE Mark approval for use in the EEA.
STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee) enrolled its final patient earlier this month marking the completion of the study. MicroStent is a vascular stent specifically designed to achieve and maintain tibioperoneal arterial patency improving blood flow and wound healing for below-the-knee amputation reduction in patients with critical limb ischemia (CLI) resulting from progressive peripheral artery disease (PAD). 
“I would like to thank the investigators and the research teams for their dedication, participation, collaboration and tremendous effort to help this complex and difficult patient population. I’m excited to continue to provide research expertise to the company and discuss the study results when available,” said lead investigator, Dr. Robert E. Beasley of Palm Vascular Centers in Miami Beach, Florida.
“CLI/CTI is the most severe clinical manifestation of PAD. We are excited to see the data unfold to further understand the impact of angiosome directed endovascular intervention and its impact on wound healing, limb salvage and patient living independence. We are warmly appreciative to our patient population that participated in the study. The study’s goal has always been to demonstrate a lower amputation rate thereby, lowering the devastating mortality rate associated with limb loss,” commented Rita Jacob, Vice President of Clinical Affairs.
“This is an encouraging step forward for MMS, millions of patients battling CLI every day and Clinicians treating and caring for these patients,” said CEO, Gregory Sullivan. “MMS developed the MicroStent platform in response to patients’ needs, and we are excited to move closer to putting MicroStent in the hands of U.S. interventionalists treating CLI.”
For more about Micro Medical Solutions, visit www.micromedicalsolutions.net.
SOURCE Micro Medical Solutions

WILMINGTON, Mass.–(BUSINESS WIRE)–Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that improve clinical outcomes and quality of life, announced today that it has completed building a Scientific Advisory Board that includes six international leaders in treatment […]