The Latest Cardiac and Vascular News
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 […]
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 few months after the company received IDE approval for SELUTION […]
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 trial which will establish the evidence that this novel technology […]
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, 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 limus release DEB catheter, in the treatment of atherosclerotic lesions […]
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, […]
