Micro Medical Solutions Announces CE Mark for MicroStent
Steady stream of innovation, approvals, and clearances continues, more to follow in 2017
Wilmington, MA February 10, 2017—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.
NOT FOR COMMERCIAL SALE IN THE US.CONTACT: Peg Thornton, Director of Corporate and Market Development, Micro Medical Solutions 732-616-9123