Tag: MedAlliance

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 limus release DEB catheter, in the treatment of atherosclerotic lesions […]

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 sirolimus-eluting balloon that provides a controlled sustained release of drug, […]

12-Month Below-the-Knee Data with MedAlliance’s SELUTION SLR™ Presented as Late Breaking Trial at LINC

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 […]

MedAlliance announces successful completion of enrolment in ISABELLA clinical trial for the treatment of failing AV fistulas in hemodialysis patients

NYON, Switzerland, Nov. 24, 2020 /PRNewswire/ — MedAlliance has announced completion of patient enrolment in the ISABELLA Clinical Trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of dysfunctional AV fistulas in end-stage renal failure patients undergoing hemodialysis. SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained […]

Enrolment of First Two Patients in PRISTINE Study with SELUTION SLR™ Sirolimus Drug Eluting Balloon

NYON, Switzerland, Oct. 11, 2020 /PRNewswire/ — MedAlliance has announced enrolment of the first two patients in the PRISTINE registry with SELUTION SLR™ 018 DEB for the treatment of patients with Below The Knee disease (Chronic Limb Threatening Ischemia). This is the first DEB accepted by the FDA for its “Breakthrough Program”. SELUTION […]

MedAlliance Gains CE Mark Approval for Coronary SELUTION SLR™ Sirolimus Drug Eluting Balloon

NYON, Switzerland, June 30, 2020 /PRNewswire/ — MedAlliance has announced the award of its second CE Mark: SELUTION SLR™ 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad […]

MedAlliance Gains CE Mark Approval for Coronary SELUTION SLR™ Sirolimus Drug Eluting Balloon

MUMBAI, India, June 16, 2020 /PRNewswire/ — MedAlliance has announced the award of its second CE Mark: SELUTION SLR™ 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad […]

MedAlliance Receives CE Mark Approval for SELUTION SLR™ Sirolimus Drug Eluting Balloon for Endovascular Applications

3 February 2020 – MedAlliance has announced the award of its first CE Mark approval: for SELUTION SLR™, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of peripheral arterial disease. This approval applies to sizes from 2.0 x 20mm to 7.0 x 150mm. This award was supported by two-year […]