BD’s Rotarex Atherectomy and Thrombectomy Catheter System Assessed at 12 Months

November 4, 2022—The Rotarex catheter (BD Interventional) is being evaluated in a prospective, multicenter, single-arm study designed to assess the device’s technical/procedural success, safety, and primary patency. The Rotarex is a rotating and aspirating atherectomy and thrombectomy catheter system.

The study enrolled 220 patients at 14 centers in Europe from July 2019 through September 2020. The Rotarex catheter study is an ongoing study with a follow-up period of 24 months.

Michael Lichtenberg, MD, presented the 12-month results from the study during the second of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

As summarized in the VIVA Foundation press release, the technical/procedural success (defined as the ability to cross and successfully treat the target lesion) was measured at completion of the index procedure. The safety measure (defined as freedom from major adverse events [MAEs]) was collected through 30 days.

Primary patency was collected at 1, 6, 12, and 24 months and defined as freedom from clinically driven target lesion revascularization (TLR) and freedom from > 50% stenosis (peak systolic velocity ratio < 2.5).

Secondary outcomes at 1, 6, 12, and 24 months included safety events, freedom from target vessel revascularization (TVR), walking improvement (VascuQoL-6), quality-of-life improvement (EQ-5D-3L), and various subcohort analyses.

Dr. Lichtenberg reported that technical/procedural success where Rotarex was used alone was 47.2%. When used with adjunctive treatments (in 97.7% of the cohort), technical/procedural success was 94.1%.

Primary patency at 1, 6, and 12 months was 87.2%, 68.1%, and 57.8%, respectively.

At 1 month, the freedom from MAEs was 94.4%; freedom from TLR was 96.7%; and freedom from TVR was 99.1%.

The investigators found that these outcomes were sustained through 6 and 12 months. Most patients showed improvement in Rutherford class, and improvements were also observed in the quality-of-life measures, noted the VIVA Foundation press release.