510K clearance for MicroGuide, part of the Micro Medical Solutions Micro Vascular Integrated Platform (mVIP)

Wilmington, MA March 16, 2016—Micro Medical Solutions announces it has received 510K clearance for one of its key interventional innovations. “The MicroGuide offers a best-in-class 3Fr design with optimal push, support, and stability with enhanced flexibility for segment-leading device deliverability and support,” says Gregory Sullivan, CEO of Micro Medical Solutions. The MicroGuide is one part of a new delivery platform, the Micro Vascular Integrated Platform (mVIP), planned for the treatment of critical limb ischemia (CLI) lesions that are Below the Knee (BTK). Approval for the MicroBalloon is expected by Q3 2016 with the rest of the components and the complete mVIP system expected in 2017.

CONTACT: Peg Thornton, Director of Corporate and Market Development, Micro Medical Solutions 732-616-9123

About CLI

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.

References: 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[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.

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