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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.