Andomized Study 377 Subjects Are Being Randomized 1 To Either Selution Slr Or The Control This Is First Of Its Kind Where 39 Real World Patients With Cli Critical Limb Ischemia Can Be Included Enrolled At Approximately 40 Sites Across Us News Today : Breaking News, Live Updates & Top Stories | Vimarsana
LEIPZIG, Germany, June 8, 2022 /PRNewswire/ The first patient has been enrolled in the FDA IDE BTK (Below-the-Knee) SELUTION4BTK clinical trial involving SELUTION SLR, MedAlliance's novel sirolimus-eluting balloon, just one week after receiving IDE approval. "I am excited to begin an important trial which will establish the evidence that this novel technology benefit patients suffering from CLTI," commented Dr. Michael Lichtenberg, Chief of the Angiology Department at the Klinikum Hochsauerland, Arnsberg, Germany. "So far nothing has worked consistently in this patient population. The early clinical data from SELUTION SLR registries are encouraging and I have seen the performance of this new technology in my routine work. This study is designed to prove that SELUTION SLR is more effective than the current standard of care in this difficult patient population." The start of enrollment in the study follows IDE (Investigational Device Exemption) approval in the U