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 […]
Tag: MedAlliance
MedAlliance SELUTION SLR Receives Second FDA IDE Approval
GENEVA, Aug. 9, 2022 /PRNewswire/ — SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a […]
First Patient Enrolled in SELUTION SLR IDE BTK Study
GENEVA, June 7, 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 […]
MedAlliance’s SELUTION SLR drug eluting balloon (DEB) receives FDA investigational device exemption (IDE) approval – making it the first limus DEB to be available to US patients
GENEVA, May 30, 2022 /PRNewswire/ — The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted “breakthrough […]
18-Month Below-the-Knee Data with MedAlliance’s SELUTION SLR™ Presented as Late Breaking Trial at VIVA
GENEVA, Oct. 8, 2021 /PRNewswire/ — 18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a Late Breaking Clinical Trial at VIVA21. The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR™, MedAlliance’s […]
MedAlliance announces completion of enrollment in Japanese SELUTION SLR™ Study
GENEVA, Switzerland, Sept. 22, 2021 /PRNewswire/ — MedAlliance, with its Japanese partner MDK Medical, has completed enrollment in the clinical study of its novel Sirolimus Drug Eluting Balloon (DEB), SELUTION SLR™, for the treatment of peripheral arterial disease (PAD). This follows the acceptance of […]
MedAlliance Announces First Patient Enrolled in the 3,300 Patient Landmark Sirolimus DEB vs DES Study
GENEVA, Sept. 1, 2021 /PRNewswire/ — MedAlliance is pleased to announce the enrollment of the first patient in the ground-breaking coronary randomized controlled study “SELUTION DeNovo”. This study utilizes SELUTION SLR™, a novel sirolimus drug-eluting balloon [DEB], versus a limus drug-eluting stent […]
MedAlliance announces Completion of Enrolment in PRISTINE Clinical Trial with SELUTION SLR™ Sirolimus Drug Eluting Balloon
NYON, Switzerland, Aug. 12, 2021 /PRNewswire/ — MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of patients with Below-the-Knee (BTK) disease. SELUTION SLR is the first DEB to be awarded […]
MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions
NYON, Switzerland, March 4, 2021 /PRNewswire/ — MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR™, its sustained […]
First Patient Enrolled in SELUTION SLR™ SUCCESS PTA Study
NYON, Switzerland, Feb. 10, 2021 /PRNewswire/ — MedAlliance has announced enrolment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon SELUTION SLR™ for the treatment of patients with peripheral artery disease (PAD). SELUTION SLR is a novel […]