Micro Medical Solutions

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 compan…

Micro Medical Solutions today said it has received FDA breakthrough device designation for its MicroStent vascular stent.

The stent is designed to maintain vessel patency, enhance wound treatment and improve quality of life and blood flow to reduce amputations and morality for patients with critical limb-threatening ischemia (CLTI) from peripheral artery disease.

“FDA breakthrough device designation is an exciting step forward for MMS and for patients with CLTI, who will have expedited access to MicroStent. We are pleased that the FDA is recognizing the importance and severity of CLTI and look forward to collaborating with them as we go through the PMA process,” CEO Gregory Sullivan said in a news release. “As we remain focused on the completion of our FDA clinical study, STAND, it is gratifying to know we are now one step closer to our goal to help as many CLTI patients as possible live without the trauma of amputation.”

The Micr…