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DCB shows promise in first-in-human study
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A novel sirolimus-coated balloon demonstrated safety and effectively treated long lesions at 6 months, according to the results of a first-in-human study presented at the CRT conference.
The balloon (Selution, Med Alliance) achieved its 6-month primary endpoint for late lumen loss of the target lesion at 0.19 mm (95% CI, –1.16 to 3.07), as measured by quantitative vascular angiography, according to a press release from Med Alliance.
The 6-month rate of target lesion revascularization was 2.3%, which the company stated in the release was one of the lowest reported at the 6-month mark of a first-in-human study of a drug-coated balloon.
The DCB was tested in 50 patients with lesions in the superficial femoral and/or popliteal arteries from four centers in Germany.
There were no cases of death or amputation, according to the release.
A subgroup analysis of patients with long lesions (mean lesion length, 112.05 mm) found similar results as seen in the overall cohort (late lumen loss, 0.23 mm; 0% TLR), according to the release.
The DCB’s design employs micro-reservoirs made out of a biodegradable polymer that intermix with the sirolimus for a controlled and sustained drug release, and a cell-adherence technology that protects the micro-reservoirs during the procedure.
“The results from the SELUTION FIM study are promising,” presenter Thomas Zeller, MD, head of the department of angiology at the University Heart Center Freiburg-Bad Krozingen in Germany, said in the release. “The findings confirm the efficacy of the Selution sirolimus-coated technology and they concur with the previous paclitaxel drug-coated balloon studies in the superficial femoral artery. Rutherford classification, ankle-brachial index, walking impairment and quality-of-life assessment have all indicated beneficial patient improvement from this sirolimus technology.”
Reference:
Zeller T, et al. Late Breaking Trials: Session 3. Presented at: CRT 2018; March 3-6, 2018; Washington, D.C.
Disclosure: The study was funded by Med Alliance. Zeller reports he has consulted for Bard, Biotronik, Boston Scientific, Medtronic, Spectranetics and Trireme.