Intervention Progress

Evaluation of BTK intervention with pedal access device

Micro Medical Solutions is taking a stand against the impact of critical limb ischemia (CLI) amputations by developing innovations that will allow interventionists to improve clinical outcomes and patient quality of life. Micro Medical Solutions has a specific goal: to improve Below the Knee (BTK) interventions, thereby reducing the number of amputations due to peripheral artery disease (PAD) and CLI and minimizing the significant morbidity, mortality, and healthcare burden associated with atherosclerotic disease.

Progress toward better BTK interventions

The Micro Vascular Integrate Platform (mVIP) is comprised of the MicroStent, MicroBalloon, and MicroGuide. MicroStent has CE Mark approval with anticipated enrollment completion in the U.S. IDE clinical trial in Q4, 2023. The MicroBalloon and MicroGuide have US FDA 510Kclearance.

Currently in clinical development

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The MicroGuide features best-in-class 3Fr design with optimal push, support, and stability with enhanced flexibility for segment-leading device deliverability and support

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The MicroBalloon offers ultra-low profile design and a microfilament wire for maximum push and optimal support

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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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