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Interim results of covered stent-graft hint at ‘new avenue’ in dialysis access treatment
The interim results of a first-in-human trial of a sirolimus-eluting covered stent graft—Solaris DE (Solaris Endovascular)—for the treatment of dialysis access dysfunction demonstrate the promise of the device in treating vascular access outflow stenosis, an investigator in the trial has…
Two-year SWING data ‘continue to show promise’ for sirolimus DCB in treating BTK disease
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 presented at this year’s VEITHsymposium (Nov. 14–18) in New York City. The SWING trial is a…
Surmodics provides regulatory update related to FDA premarket approval application for SurVeil
Surmodics recently announced it has received a letter from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB). In the letter, the FDA indicated that the application is not currently…
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. 9–11 in Lugano, Switzerland. The SWING study is a prospective, multicenter, single-arm feasibility study to evaluate…
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 for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a…
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 DEB to be available to U.S. patients, the company announced in a press release. The Selution…
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 for dialysis. These findings were delivered by Tjun Tang, MD—who also highlighted “excellent” technical and clinical…
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 Efemoral vascular scaffold system marks a significant milestone in a mission to save legs and provide…
PAD: R3 Vascular reports ‘successful initiation’ of first-in-human study of bioresorbable sirolimus-eluting scaffold
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 bioresorbable sirolimus-eluting scaffold (BRS) in patients with critical limb ischemia (CLI) due to occlusive below-the-knee (BTK)…
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 (BTK) disease. According to a MedAlliance press release, Selution SLR is the first DEB to be…