Micro Medical Solutions has received CE mark approval for MicroStent, a vascular stent specifically designed to reduce below-the-knee amputations for critical limb ischemia (CLI) resulting from peripheral artery disease.
It is the third MMS innovation to receive CE Mark approval in the past year.
"The MicroStent is the centerpiece of an integrated delivery platform that will help fill an unmet need in the interventional community. Amputation prevention in this CLI patient population is an ongoing fight, and we welcome new tools that have such promise to make a difference," said Dr. Jihad Mustapha, a board-certified interventional cardiologist specializing in minimally invasive, non-surgical therapy for heart and peripheral vascular disease.
A global thought leader for amputation prevention in the treatment of patients with CLI, Dr. Mustapha has been instrumental in guiding clinical and regulatory pathways for MMS.
"This major milestone for MMS brings our Micro Vascular Integrated Platform, which includes MicroStent, one step closer to becoming available to European physicians," Micro Medical Solutions CEO Gregory Sullivan added.
"We are delighted to share this exciting news with interventionists, who are seeking much-needed innovation in this underserved area."
MMS' Micro Vascular Integrated Platform (mVIP) includes the MicroStent, MicroBalloon and MicroGuide.
Together, these technologies are designed to provide optimal treatment of CLI lesions below the knee, reducing the risk of amputation. The MicroBalloon and MicroGuide have already received CE Mark and 510(k) clearances.
Greg Mathison, Director of Regulatory and Clinical Affairs at MMS, confirms the importance of CE Mark but anticipates even more exciting news to follow. "This approval is an important step forward in our regulatory path. We look forward to providing data from a U.S. clinical trial of the MicroStent in 2017."
Peripheral artery disease and critical limb ischemia (CLI) affect millions each year. It has been estimated that nearly 25% of CLI patients will undergo major amputation, and amputations due to CLI continue to escalate/