October 13, 2020
2.5mm MicroStent and MicroBalloon XL have received the CE Mark. The news was announced today by Micro Medical Solutions.
2.5 mm MicroStent vascular stent, the smallest diameter MicroStent to date has received the CE Mark. The news was announced today by Micro Medical Solutions. Also granted CE Mark approval is the long (150 cm) over-the-wire balloon catheter, MicroBalloon XL. The MicroStent and MicroBalloon are part of the MMS Micro Vascular Integrated Platform (mVIP), 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) resulting from peripheral artery disease (PAD).
“We’re very pleased to receive CE Mark approval for both the 2.5 mm MicroStent and 150 cm MicroBalloon XL,” said Micro Medical Solutions CEO Gregory Sullivan. “By expanding our portfolio of interventional devices, we are broadening the base of patients with CLI whom we can treat to avoid a life-altering below-the-knee amputation.”
Already available in diameters of 3.0-4.5 mm, MicroStent can now be used in vessels as small as 2.5 mm, all available in lengths of 8 mm, 15 mm, 25 mm, 40 mm and 60 mm. Diabetes, a common comorbidity of PAD and CLI, may cause patients to have smaller blood vessels requiring a smaller stent. The addition of a longer 150 cm MicroBalloon XL to the MicroBalloon line (40, 60, 80, and 100 mm) makes it possible for surgeons to take a contralateral or ipsilateral approach to treatment, expanding their options beyond a pedal approach. Greater flexibility permits surgeons to choose the wisest entry point and customize the equipment to each patient’s needs.
Designed for effective, efficient treatment of CLI resulting from PAD, the mVIP suite of devices has previously been CE Mark approved in both a 3Fr. and 4Fr. delivery system, providing the least invasive approach for patients. MMS is currently engaged in an FDA randomized, multicenter pivotal clinical study for MicroStent, called STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee), which began in May 2020 and will continue this year at up to 25 sites across the U.S. MicroBalloon has FDA 510(k) clearance. In addition, the MMS study HEAL (An All-Comers Observational Study of the MicroStent Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease) is currently enrolling patients at centers in the EU.
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2. Baser O, Verpillat P, Gabriel S, et al. Prevalence, incidence, and outcomes of critical limb ischemia in the US Medicare population. Vasc Dis Mgmt. 2013:10;E26-36.