Tag: sirolimus
Two-year SWING data ‘continue to show promise’ for sirolimus DCB in...
Two-year data from the SWING trial, a first-in-human study of the safety and performance of the Sundance sirolimus drug-coated balloon (DCB; Surmodics), have been...
Surmodics provides regulatory update related to FDA premarket approval application for...
Surmodics recently announced it has received a letter from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the...
Six-month data from SWING below-the-knee, first-in-human trial presented at AMP Europe
Six-month data from the Surmodics SWING first-in-human (FIH) study of the company’s Sundance sirolimus drug-coated balloon (DCB) were shared at the 2022 Amputation Prevention Symposium (AMP) held Oct....
Selution SLR receives second FDA IDE approval
Selution SLR, MedAlliance’s sirolimus-eluting balloon, has received conditional Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical trial...
FDA grants IDE approval for Selution SLR drug-eluting balloon
MedAlliance’s Selution SLR drug-eluting balloon (DEB) has received investigational device exemption (IDE) approval from the Food and Drug Administration, making it the first limus...
New sirolimus data provide encouragement despite ‘potentially disappointing’ efficacy results
The results of a small-scale pilot study from Asia have indicated “potentially disappointing” results with a novel drug-eluting balloon in treating dysfunctional arteriovenous access...
Potential ‘new paradigm’ in treatment of long occlusive lesions emerges
Vascular surgeon Lewis Schwartz, MD, has had an interest in biomedical engineering since very early in his career. So his involvement in the early-stage...
PAD: R3 Vascular reports ‘successful initiation’ of first-in-human study of bioresorbable...
Medical device developer R3 Vascular has reported the "successful initiation" of a first-in-human clinical study evaluating the technical and clinical performance of its Magnitude...
PRISTINE registry with Selution SLR sirolimus drug-eluting balloon completes enrollment
MedAlliance has announced completion of patient enrollment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee...
Innovation: ISET audience hears what’s on the horizon for CLTI patients
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider, MD, professor of vascular and endovascular surgery...
Postmarket study of sirolimus-eluting balloon enrolls first patient
MedAlliance has announced enrollment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon Selution SLR for the treatment...
‘Successful’ first-in-human use of the Efemoral scaffold system announced
Efemoral Medical has announced the first-in-human (FIH) use of the company’s Efemoral Vascular scaffold system (EVSS) with FlexStepv technology in the EFEMORAL I FIH...