Progress toward better BTK interventions
The Micro Vascular Integrated Platform (mVIP), comprised of the MicroStent, MicroBalloon, and MicroGuide, has full EU CE Mark approval. The MicroBalloon and MicroGuide have US FDA 510K clearance, with commencement of the U.S. IDE clinical trial for MicroStent expected in 2023.
The MicroGuide features best-in-class 3Fr design with optimal push, support, and stability with enhanced flexibility for segment-leading device deliverability and support
The MicroBalloon offers ultra-low profile design and a microfilament wire for maximum push and optimal support
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 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.
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