Study Compares Outcomes of DCB Versus POBA After B-Laser Atherectomy


November 5, 2019—VIVA Physicians announced that data for the B-Laser 355-nm–wavelength laser-technology platform (Eximo Medical Ltd., acquired by AngioDynamics, Inc. in October 2019) were presented by John H. Rundback, MD, during the first late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.

The VIVA announcement stated that the B-Laser atherectomy device’s laser has a very short pulse width to selectively ablate mixed-morphology plaque including calcification.

Composed of patients in the European CE Mark and United States investigational device exemption trials of the B-Laser, the investigators compared outcomes of B-Laser treatment followed by either plain old balloon angioplasty (POBA; n = 46) or drug-coated balloon (DCB) angioplasty (n = 51). Clinical characteristics were similar between the two groups. POBA patients had more popliteal and tibial lesions treated (77.8% and 84.2% vs 11.1% and 15.8% in the DCB group), but other lesion characteristics were similar.

Investigators found that there were no major procedural complications, including no embolization or grade C to E dissections. Core lab–adjudicated duplex patency at 6 months was 89.5% in the POBA group and 85.2% in the DCB group. One-year clinical improvement (ankle-brachial index, Rutherford score) was the same.

The conclusion from these preliminary data is that there were no differences in measurable short-term outcomes after B-Laser atherectomy, regardless of subsequent mode of angioplasty. The characteristics of plaque modification after B-Laser atherectomy may impact outcomes and mitigate previously noted patency and clinical benefits of DCB angioplasty, advised in the investigators in the VIVA announcement.


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