The Latest Cardiac and Vascular News
GENEVA, May 30, 2023 /PRNewswire/ — 12-month results from the SELUTION SFA trial have been presented at the Japan Endovascular Treatment (JET) Conference in Tokyo. The objective of this study was to assess the safety and efficacy of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for endovascular therapy of de novo and non-stented restenotic lesions in the […]
GENEVA, Jan. 25, 2023 /PRNewswire/ — The first US patient has been enrolled at MedStar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to support FDA approval. This milestone follows Investigational Device Exemption (IDE) approval in the US in October 2022. SELUTION SLR is the first sustained limus release coronary drug-eluting balloon […]
MIAMI LAKES, Fla., Oct. 18, 2022 /PRNewswire/ — Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technologies, today announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance, a Switzerland-based company at the forefront of transformative drug-eluting balloons. By acquiring MedAlliance, Cordis has the potential to […]
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 device designation” by the FDA on March 4, 2019 and further in September […]
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 novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions […]
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 a Clinical Trial Notification (CTN) by Japan’s Pharmaceutical and Medical Device Agency […]
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 [DES]. This is the largest DEB study ever initiated, with […]
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 “Breakthrough Device Designation” by the FDA. PRISTINE is a Prospective Registry to Investigate […]
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 sirolimus-eluting balloon that provides a controlled sustained release of drug, […]
NYON, Switzerland, Jan. 28, 2021 /PRNewswire/ — 12-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a Late Breaking Trial at LINC 2021. The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive […]
