Micro Medical Solutions announces it has received European CE Mark approval for the MicroStent, the third of its key innovations to receive CE Mark in the last year.
“This is a major milestone, one step closer to our Micro Vascular Integrated Platform, including the MicroStent, becoming available to European physicians. It’s exciting news for interventionists seeking much-needed innovation in an underserved area.” said Gregory Sullivan, CEO of Micro Medical Solutions. Greg Mathison, Director, Regulatory and Clinical Affairs for Micro Medical Solutions, 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 and we look forward to providing U.S. based data in the near term from our clinical trial with the MicroStent.”
The Micro Vascular Integrated Platform (mVIP) includes the MicroStent, MicroBalloon, and MicroGuide, and is designed for treatment of critical limb ischemia (CLI) lesions that are Below the Knee (BTK). This latest CE Mark approval is in addition to recent CE Mark and 510(k) clearances for the MicroGuide and MicroBalloon.
“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,” commented Dr. Jihad Mustapha, a board-certified interventional cardiologist specializing in minimally invasive, non-surgical therapy for heart and peripheral vascular disease. Dr. Mustapha has been instrumental in guiding clinical and regulatory pathways for MMS, and is a global thought leader for amputation prevention in the treatment of patients with Critical Limb Ischemia.
Director of Corporate and Market Development,
Micro Medical Solutions
Peripheral artery disease (PAD) and critical limb ischemia (CLI) affected 215 million people worldwide in 2015, predicted to be 230 million by 2020.1 CLI currently afflicts 2.8 to 3.5 million of those with PAD and is projected to rise to 4.5 to 5.6 million.2 Rates of amputations in the general population with PAD are declining, but amputations in CLI continue to escalate. It has been estimated that 25% of CLI patients will undergo major amputation. Prognosis with respect to limb preservation in CLI patients is poor, particularly in no-option CLI patients, where six-month major amputation rates have been reported to be as high as 50%.3 If something doesn’t change, the number of amputations due to CLI could exceed one million by 2030.
1. Global Peripheral Artery Disease Market: Trends & Opportunities (2015-2020), February 2016 (Page 19). Daedal Research Group.
2. Critical Limb Ischemia. Volume 1 United States Epidemiology, 2010.Accessed at http://thesagegroup.us/pages/rep[orts/cliepiusreprot.php
, October 14, 2016. 3. Teraa M, Conte MS, Moll FL, Verhaar MC.
Contemporary Reviews: Critical Limb Ischemia: Current Trends and Future Directions. J Am Heart Assoc 2016; 5: e002938.