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First patient enrolled in Erectile Dysfunction prospective randomized study with SELUTION SLR

GENEVA, Switzerland, Sept. 10, 2022 /PRNewswire/ An 82-year-old Taiwanese man has become the first patient to be enrolled in the initial Erectile Dysfunction (ED) randomized clinical trial (RCT) involving SELUTION SLR, MedAlliance's novel sirolimus-eluting balloon. The PERFECT-SELUTION FIM (PElvic Revascularization For EreCTile dysfuction-SELUTION First-In-Man) study involves a total of 54 patients suffering from distal internal pudendal-penile artery stenotic disease and ED. They are being randomized to treatment with either SELUTION SLR or plain old balloon angioplasty (POBA), then followed-up for a period of 12 weeks. The primary efficacy endpoint of the study is angiographic binary restenosis (>50% lumen diameter stenosis) defined by computer tomography (CT) and the primary safety endpoint is the rate of major adverse events. "We are excited to begin this study on such a long-suffering patient population. We hope that this study will give these patients a better chan ....

National Taiwan University Hospital , T Ai Pei , Switzerland General , United States , United Kingdom , Richard Kenyon , Tzung Dau Wang , Ma Med Alliance , Cath Lab , Cell Adherent Technology , Erectile Dysfunction , Revascularization For , Cardiac Cath Lab , Sept 10 , 022 Prnewswire An 82 Year Old Taiwanese Man Has Become The First Patient To Be Enrolled In Initial Erectile Dysfunction Ed Randomized Clinical Trial Rct Involving Selution Slr , Edalliance 39s Novel Sirolimus Eluting Balloon The Perfect Selution Fim Pelvic Revascularization For Erectile Dysfuction First In Man Study Involvesa Total Of 54 Patients Suffering From Distal Internal Pudendal Penile Artery Stenotic Disease And Ed They Are Being Randomized To Treatment With Either Slr Or Plain Old Angioplasty Poba , Hen Followed Up Fora Period Of 12 Weeks The Primary Efficacy Endpoint Study Is Angiographic Binary Restenosis Gt 50 Lumen Diameter Stenosis Defined By Computer Tomography Ct And Safety Rate Major Adverse Events Quot We Are Excited To Begin This On Sucha Long Suffering Patient Population Hope That Will Give These Patientsa Better Chance Ofa Normal Life , Nd Look Forward To The Results , Uot Said Tzung Dau Wang , Rofessor Of Medicine And Director Cardiac Cath Lab , National Taiwan University Hospital , Ho Has Performed Pudendal And Penile Artery Angioplasty With Conventional Devices Poba Or Stents On More Than 500 Patients Arteriogenic Erectile Dysfunction Acknowledged That Restenosis Occurred In 30 Of Treated Quot We Do Needa State The Art Technology To Break This Barrier Are Pleased Initiate Study First Patient Responded Well Therapy Have Been Very Clinical Results Many Applications Stent , Oronary De Novo , Oth Below And Above The Knee , V Fistula And Now Erectile Dysfunction This Combination Drug Device Technology Seems To Be Very Versatile , Nd We Look Forward To The Results From This Physician Initiated Study ,

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. "We are encouraged by the positive early outcomes with this novel SELUTION SLR Sirolimus Drug Eluting Balloon (DEB) in Europe and Asia. We hope this FDA IDE trial will demonstrate significant benefit for patients who currently have limited treatment options." The aim of the SELUTION4BTK clinical trial is to demonstrate the superior efficacy and equivalent safety of SELUTION SLR compared ....

United States , North Carolina , United Kingdom , Switzerland General , Richard Kenyon , Ehrin Armstrong , Ma Med Alliance , Cell Adherent Technology , Vascular Solutions In Cary , Investigational Device Exemption , Principal Investigator , Drug Eluting Balloon , Chronic Limb Threatening Ischemia , Vascular Solutions , Breakthrough Device Designation , Medalliance Chairman , Aug 24 , 022 Prnewswire The First Us Patient Has Been Enrolled In Fda Selution4btk Below Knee Clinical Trial Evaluating Selution Slr , Edalliance 39s Novel Sirolimus Eluting Balloon This Milestone Follows Investigational Device Exemption Ide Approval In The Us May 2022 , Ith 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 Population , Uot 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 Prospective , Multi Center , Single Blinded , Andomized 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 Us , Urope And Asia This First Us Patient Was Enrolled At Vascular Solutions In Cary , Orth Carolina By Dr Siddhartha Rao Quot We Are Very Pleased To Be Participating In This Groundbreaking Study ,

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 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 ,