One-Year Data Presented for B. Braun's SeQuent Please Over-the-Wire Drug-Coated Balloon

February 14, 2017—One-year clinical trial data regarding use of B. Braun Melsungen AG’s SeQuent Please Over-the-Wire (OTW) drug-coated balloon (DCB) in femoropopliteal lesions were recently presented at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany. The clinical outcomes from the CONSEQUENT Trial were presented by Prof. Thomas Albrecht, Principal Investigator and Head of Radiology and Interventional Therapy at Vivantes Hospital in Berlin, Germany.

B. Braun Melsungen AG describes the SeQuent Please OTW DCB as a paclitaxel-coated balloon with a nominal dose of 3 µg/mm² that is integrated into a matrix with resveratrol. According to the company, preclinical testing of the DCB revealed a favorable coating integrity and stability which does not appear to require lesion predilatation in nonocclusive stenoses.

Per the announcement, in his presentation, Prof. Albrecht described a study cohort that included complex lesions with an average length of 13.2 ± 10.4 cm; nearly a quarter of all lesions treated were determined to be TASC II C/D lesions.

The data cited in the announcement included that at 12-month follow-up, the target lesion revascularization (TLR) rate in the SeQuent Please OTW group was significantly lower than that of the uncoated balloon group (17.8% vs 37.7%; P = .008). Similarly, the Rutherford category improvement was significantly better in the DCB group (2.5 ± 1 vs 1.8 ± 1.3; P = .010). The walking distance increase was reported to be roughly twice as high in the SeQuent Please OTW group compared with the uncoated balloon group (165 ± 105 m vs 94 ± 136 m; P = .012).

According to the company, Prof. Albrecht concluded that the increase in walking distance in the SeQuent Please OTW group combined with the TLR rate at 12 months represent important quality of life findings for patients with peripheral artery occlusive disease.