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 ....

Nordrhein Westfalen , United States , United Kingdom , Switzerland General , Richard Kenyon , Michael Lichtenberg , Klinikum Hochsauerland , Ma Med Alliance , Cell Adherent Technology , Angiology Department , Investigational Device Exemption , Breakthrough Device Designation , Chronic Limb Threatening Ischemia , Critical Limb Ischemia , Medalliance Chairman , June 8 , 022 Prnewswire The First Patient Has Been Enrolled In Fda Ide Btk Below Knee Selution4btk Clinical Trial Involving Selution Slr , Edalliance 39s Novel Sirolimus Eluting Balloon , Ust One Week After Receiving Ide Approval Quoti Am Excited To Begin An Important Trial Which Will Establish The Evidence That This Novel Technology Benefit Patients Suffering From Clti , Uot Commented Dr Michael Lichtenberg , Hief Of The Angiology Department At Klinikum Hochsauerland , Ermany Quot So Far Nothing Has Worked Consistently In This Patient Population The Early Clinical Data From Selution Slr Registries Are Encouraging Andi Have Seen Performance Of New Technology My Routine Work Study Is Designed To Prove That More Effective Than Current Standard Care Difficult Start Enrollment Follows Ide Investigational Device Exemption Approval Us One Week Ago Btk Indication For Was Granted Breakthrough Designation By Fda 2019 Aim Selution4btk Trial Demonstrate Superior Efficacy And Equivalent Safety Compared Plain Uncoated Balloon Angioplasty Poba Treatment Arteries Clti Chronic Limb Threatening Ischemia Patients Isa Prospective , Multi Center , Single Blinded , 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 , Urope And Asia Quoti Am Very Proud Of The Medalliance Team Which Has Been Able To Initiate This Study So Quickly Have First Patient Enrolled Onlya Week After Receiving Ide Approval ,