Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions designed to improve clinical outcomes and quality of life, announced today that it has received CE Mark approval for a 4Fr.-compatible MicroStent 120 cm delivery catheter, as well as MicroStent devices in five lengths and five diameters to meet individual patient needs. MicroStent is a vascular stent specifically designed to reduce below-the-knee amputations caused by critical limb ischemia (CLI) resulting from peripheral artery disease.
Peripheral artery disease can make it challenging to navigate small, calcified blood vessels in the lower leg. Using the new 120 cm MicroStent catheter, physicians will now have multiple access points above the knee, expanding and optimizing the treatment options for CLI. In addition, the newly approved MicroStent sizes of 8mm,15mm, 25mm, 40mm and 60mm will allow physicians to choose the stent length based on the best fit for each patient’s diseased artery, allowing for a more customized approach.
“For patients with CLI, insufficient blood flow to the lower leg causes pain and, eventually, tissue damage. The end result can be amputation below the knee,” explained Dr. Robert E. Beasley Mount of Sinai Medical Center in Miami Beach, Florida. “When we implant the MicroStent, we restore the vessel, alleviate pain, and ultimately save the limb. The 120 cm catheter gives us more options, so we can choose the best access point for each patient. The new, robust 3.2Fr shaft provides excellent push and control when transmitting movement from the more distant femoral access point. It’s the perfect balance of femoral access and control.”
CE Mark approval of the 120 cm delivery catheter and multiple MicroStent sizes are the latest in a series of accomplishments for this limb-saving technology. MicroStent achieved CE Mark approval in 2017, followed by the first case in the U.S. in 2018. The company is currently concluding a Phase I FDA clinical trial, with results expected as early as December 2018.
“At MMS, we are very proud of our achievements with MicroStent, and we feel a genuine sense of excitement giving physicians the tools to help patients avoid a life-changing amputation,” said Micro Medical Solutions CEO Gregory Sullivan. “As we continue moving toward approval of MicroStent in the U.S., it is important to us to keep innovating to help more patients with CLI, and the 120 cm MicroStent delivery stent and choice of sizes promise to do just that.”
Physicians interested in learning more about the MicroStent’s development can attend Dr. Beasley’s CME presentation on the device’s feasibility study at the Vascular Interventional Advances (VIVA) conference, held November 5 – 8 in Las Vegas.
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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.