Micro Medical Solutions announced today that it completed enrollment in a U.S. pivotal clinical study of its MicroStent system.
Wilmington, Massachusetts-based Micro Medical set up its study to evaluate MicroStent’s safety and effectiveness. The study pits the stent against the current standard of care, percutaneous transluminal angioplasty (PTA).
MicroStent, a vascular stent, was designed to achieve and maintain tibioperoneal arterial patency. Micro Medical aims for it to improve blood flow and wound-healing for below-the-knee (BTK) amputation reduction in patients with critical limb ischemia (CLI) resulting from progressive peripheral artery disease (PAD). MicroStent currently holds CE mark approval but remains investigational in the U.S.
STAND, a trial led by Dr. Robert E. Beasley of Palm Vascular Centers in Miami Beach, Florida, enrolled its final patient earlier this month.
Micro Medical VP of Clinical Affairs Rita Jacob said the company is excited to see the data unfold in the study. Jacob listed the aim as demonstrating a lower amputation rate. This would lower the “devastating mortality rate associated with limb loss.”
“This is an encouraging step forward for MMS, millions of patients battling CLI every day and clinicians treating and caring for these patients,” said Micro Medical 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.”