Clinical EvidenceSerranator V POBA
Improvement in Residual Stenosis
Total
Improvement in Residual Stenosis in CTO
Serranator outperformed POBA by an even wider margin in the most severe disease.
Average Pressure Used with Serranator
Lower average pressure was used with Serranator (5ATM) compared to POBA (9ATM)
Single-Center Subanalysis From the PRELUDE-BTK Prospective Study
The aim of this single-center subgroup analysis was to compare acute angiographic results after endovascular treatment using the Serranator serration balloon catheter in patients participating in the PRELUDE-BTK trial with POBA of the infrapopliteal arteries. The center enrolled 15 subjects and treated 17 lesions within the multicenter prospective core laboratory-adjudicated PRELUDE-BTK study. Then 25 lesions analyzed separately were treated with POBA and then compared with the Serranator subset. In both cohorts, lesions were treated with either plain angioplasty or Serranator as a stand-alone therapy. Acute angiographic results were analyzed by the SynvaCor angiographic core laboratory.
Final residual stenosis was 17.2%±8.2% in the Serranator group versus 33.7%±15.7% in the POBA group. The average atmospheric balloon inflation pressure was 5 ATM in the Serranator group versus 9 ATM in the POBA group. The Serranator group showed a 62% improvement in final residual stenosis over POBA in a subcategory of chronic total occlusions (CTOs).