This novel technology is designed to achieve and maintain vessel patency, enhance wound treatment, and improve quality of life and blood flow in order to reduce amputation and mortality for patients with critical limb-threatening ischemia (CLTI) resulting from peripheral artery disease (PAD).
The 2.5 mm MicroStent vascular stent, is the smallest diameter MicroStent to date. Also granted CE Mark approval is the long (120 cm) over-the-wire balloon catheter, MicroBalloon XL.
IDE approval allows the company to initiate a U.S. pivotal clinical trial to evaluate MicroStent’s safety and efficacy. MicroStent has already obtained CE Mark approval for use in the EU. MicroStent is a vascular stent specifically 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). Last fall, MMS completed a 3-center, 15-patient feasibility study of MicroStent in which MicroStent met all primary endpoints for both safety and efficacy.
11/5/18: With a longer, more robust access system and new stent sizes, physicians have more options to access and open arteries affected by critical limb ischemia and prevent lower-leg amputations.
4/26/18: To accelerate study of the MicroStent microvascular device and other new technologies designed to prevent amputation, MMS has assembled six world leaders in treating peripheral artery disease and critical limb ischemia.