United States Clinical Trial Begins for Micro Medical Solutions' MicroStent to Treat CLI
June 7, 2018—Micro Medical Solutions announced the completion of the first cases in the United States in the clinical trial evaluating the safety and efficacy of the company's MicroStent, a vascular stent specifically designed to reduce below-the-knee amputations caused by critical limb ischemia (CLI) resulting from peripheral artery disease (PAD). The US Food and Drug Administration approved the trial late last year.
The company advised that in addition to the United States clinical trial, the MicroStent received CE Mark approval in Europe in 2017 and continues to be studied internationally.
Robert E. Beasley, MD, the Coprincipal Investigator of the United States trial, performed the first procedure in the trial on April 25 at Mount Sinai Medical Center in Miami Beach, Florida. Dr. Beasley placed two 3- X 40-mm stents in the anterior tibial artery of a patient with CLI, fully restoring blood flow to a previously occluded vessel.
In the Micro Medical Solutions announcement, Dr. Beasley commented, “We found implanting the MicroStent to be a very safe, quick, easy procedure. Using a retrograde pedal puncture, we used a small 3-F sheath to place two of these very low-profile, easy-to-deploy stents in the anterior tibial artery in about 30 minutes. Postprocedural ultrasound taken immediately, at 14 days, and at 1 month showed a wide-open, unobstructed artery with excellent flow." Dr. Beasley further explained, “By returning sufficient blood flow to the lower leg, we were able to ensure adequate oxygenation to the tissue. As a result, a wound on the patient’s toe is now healing, and he is unlikely to require below-the-knee amputation. I’m hopeful that MicroStent will represent another tool to treat the devastating disease of CLI.” Dr. Beasley has performed four additionally MicroStent procedures.
Craig Walker, MD, the study's Coprincipal Investigator, has completed several cases and oversees the MicroStent research site at the Cardiovascular Institute of the South in Houma, Louisiana. Dr. Walker noted, “With CLI, the ability to achieve patency in a vessel is paramount to saving both the vessel and the limb. Use of MicroStent, a self-expanding stent with great radial force and very little chronic outward force, has resulted in patent arteries with low probability of long-term stenosis. In fact, we have seen zero stenosis postprocedure on both ultrasound and angiography, and one patient remarked that dramatic pain relief occurred immediately after the MicroStent procedure. We anticipate that this critically important technology will continue to produce good outcomes and clinical results.”