October 13, 2020
Micro Medical Solutions Announces CE Mark of 2.5-mm MicroStent and 150-cm MicroBalloon XL Catheter
October 13, 2020—Micro Medical Solutions (MMS) announced CE Mark approval for their 2.5-mm MicroStent vascular stent and 150-cm MicroBalloon XL over-the-wire balloon catheter. Both devices are a part of MMS’s Micro Vascular Integrated Platform (mVIP), which is designed to achieve and maintain vessel patency and improve blood flow in order to reduce below-the-knee amputations for patients with critical limb ischemia (CLI). The company noted that the mVIP has previously received CE Mark for both 3- and 4-F delivery systems.
With the new 150-cm MicroBalloon XL, a contralateral or ipsilateral approach to treatment is possible to better serve physician and patient needs, according to MMS. MicroBalloon has also received FDA 510(k) clearance in the United States.
Along with the 2.5-mm diameter, the MicroStent is available in the European Union in 3 to 4.5 mm diameters with lengths of 8, 15, 25, 40, and 60 mm. The MicroStent is not commercially available in the United States.
In May 2020, MMS launched STAND, a randomized, multicenter pivotal study of MicroStent at 25 sites in the United States. An all-comers observational study of the MicroStent, HEAL, is currently enrolling patients at centers in the European Union, advised MMS.