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MyJournals.org - Science - 'Effect of Kinesio tape and Compression sleeves on delayed onset of muscle soreness: a single-blinded randomized controlled trial' (BMC Musculoskeletal Disorders) - Vimarsana News

MyJournals.org - Science - 'Effect of Kinesio tape and Compression sleeves on delayed onset of muscle soreness: a single-blinded randomized controlled trial' (BMC Musculoskeletal Disorders)

MyJournals.org - Science - 'Effect of Kinesio tape and Compression sleeves on delayed onset of muscle soreness: a single-blinded randomized controlled trial' (BMC Musculoskeletal Disorders)

First US Patient Enrolled in SELUTION SLR IDE Peripheral Study - Vimarsana News

First US Patient Enrolled in SELUTION SLR IDE Peripheral Study

GENEVA, Switzerland, Aug. 24, 2022 /PRNewswire/ --The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR, MedAlliance's novel sirolimus-eluting balloon. This milestone follows Investigational Device Exemption (IDE) approval in the US in May 2022, with enrollment of the first patient occurring in Germany one week after approval. "We are very excited to finally have drug-eluting technology in the US to treat this difficult patient population," commented the trial's Principal Investigator (PI) Dr. Ehrin Armstrong...

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United StatesNorth CarolinaUnited KingdomSwitzerland GeneralRichard KenyonEhrin ArmstrongMa Med AllianceCell Adherent TechnologyVascular Solutions In CaryInvestigational Device ExemptionPrincipal InvestigatorDrug Eluting BalloonChronic Limb Threatening IschemiaVascular SolutionsBreakthrough Device DesignationMedalliance ChairmanAug 24022 Prnewswire The First Us Patient Has Been Enrolled In Fda Selution4btk Below Knee Clinical Trial Evaluating Selution SlrEdalliance 39s Novel Sirolimus Eluting Balloon This Milestone Follows Investigational Device Exemption Ide Approval In The Us May 2022Ith Enrollment Of The First Patient Occurring In Germany One Week After Approval Quot We Are Very Excited To Finally Have Drug Eluting Technology Us Treat This Difficult PopulationUot Commented The Trial 39s Principal Investigator Pi Dr Ehrin Armstrong Quot We Are Encouraged By Positive Early Outcomes With This Novel Selution Slr Sirolimus Drug Eluting Balloon Deb In Europe And Asia Hope Fda Ide Will Demonstrate Significant Benefit For Patients Who Currently Have Limited Treatment Options Aim Of Selution4btk Clinical Is To Superior Efficacy Equivalent Safety Compared Plain Uncoated Angioplasty Poba Btk Arteries Chronic Limb Threatening Ischemia Clti Isa ProspectiveMulti CenterSingle BlindedAndomized Study Clinicaltrials Gov Identifier Nct05055297 377 Subjects Are Being Randomized 1 To Either Selution Slr Or Control Treatment This Is The First Of Its Kind Where 39 Real World Patients With Clti Can Be Included Enrolled At Approximately 40 Sites Across UsUrope And Asia This First Us Patient Was Enrolled At Vascular Solutions In Cary
First Patient Enrolled in SELUTION SLR IDE BTK Study - Vimarsana News

First Patient Enrolled in SELUTION SLR IDE BTK Study

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 po...

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Nordrhein WestfalenUnited StatesUnited KingdomSwitzerland GeneralRichard KenyonMichael LichtenbergKlinikum HochsauerlandMa Med AllianceCell Adherent TechnologyAngiology DepartmentInvestigational Device ExemptionBreakthrough Device DesignationChronic Limb Threatening IschemiaCritical Limb IschemiaMedalliance ChairmanJune 8022 Prnewswire The First Patient Has Been Enrolled In Fda Ide Btk Below Knee Selution4btk Clinical Trial Involving Selution SlrEdalliance 39s Novel Sirolimus Eluting BalloonUst 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 CltiUot Commented Dr Michael LichtenbergHief Of The Angiology Department At Klinikum HochsauerlandErmany 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 ProspectiveMulti CenterSingle BlindedAndomized 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