Breakthrough Designation Helps Advance Treatment Options, Targeting a Significant Unmet Need in the Treatment of CLTI.
WILMINGTON, Mass., May 4, 2020—Micro Medical Solutions (MMS), focused on the treatment of CLTI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its MicroStent vascular stent. 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 chronic limb-threatening ischemia (CLTI) resulting from peripheral artery disease (PAD).
FDA Breakthrough Device Designation is reserved for technologies that demonstrate improved effectiveness compared to the standard of care in the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal is to give patients and doctors timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval. To further enhance patients’ access to essential new medical technologies, a Medicare coverage pathway called Medicare Coverage of Innovative Technology ensures FDA Breakthrough Devices are covered for 4 years.
“FDA Breakthrough Device Designation is an exciting step forward for MMS and for patients with CLTI, who will have expedited access to MicroStent. We are pleased that the FDA is recognizing the importance and severity of CLTI and look forward to collaborating with them as we go through the PMA process,” said Micro Medical Solutions CEO Gregory Sullivan. “As we remain focused on the completion of our FDA clinical study, STAND, it is gratifying to know we are now one step closer to our goal to help as many CLTI patients as possible live without the trauma of amputation.”
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 at up to 25 sites across the U.S. 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-Threatening Ischemia
Peripheral artery disease and critical limb-threatening ischemia (CLTI) affect millions each year. People with CLTI are at greater risk for amputation and cardiovascular morbidity and mortality.1 Within 1 year of diagnosis, patients have a 15% to 20% rate of amputation and a 15% to 40% mortality rate.2 For more information on CLTI, visit http://micromedicalsolutions.net/.
1. Barnes JA, Eid MA, Creager MA, Goodney PP. Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease. Arterioscler Thromb Vasc Biol. 2020 Aug;40(8):1808-1817.
2. Einarson TR, Acs A, Ludwig C, Panton UH. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007-2017.Cardiovasc Diabetol. 2018;17:83.
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 http://micromedicalsolutions.net/.