Micro Medical Solutions Announces CE Mark Approval of 2.5mm MicroStent and MicroBalloon XL
The 2.5 mm stent and 150 cm OTW balloon catheter will make it possible for more patients with CLI to be treated, reducing the rate of amputation.
WILMINGTON, Mass., October 13, 2020 — Micro Medical Solutions (MMS) today announced CE Mark approval for the 2.5 mm MicroStent vascular stent, the smallest diameter MicroStent to date. 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.
About Critical Limb Ischemia
Peripheral artery disease and critical limb ischemia (CLI) affect millions each year. It has been estimated that nearly 25% of CLI patients will undergo major amputation,1 and amputations due to CLI continue to escalate.2 For more information on CLI, visit www.micromedicalsolutions.net .
- Henry AJ, Hevelone ND, Belkin M, Nguyen LL. Socioeconomic and hospital-related predictors of amputation for critical limb ischemia. J Vasc Surg. 2011 Feb;53(2):330-9.e1.
- 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.
About Micro Medical Solutions
Micro Medical Solutions is on a mission to provide solutions to some of the most pressing unmet needs in microvascular intervention by helping to significantly reduce the rate of amputations, improve clinical outcomes and patient quality of life, and minimize the financial and human costs associated with the treatment of peripheral artery disease and critical limb ischemia. For more about Micro Medical Solutions, visit www.micromedicalsolutions.net .CONTACT: Peg Thornton, Director of Corporate and Market Development, Micro Medical Solutions 732-616-9123