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October 9, 2020

First-in-Human Data Presented for Axon Therapies’ Satera Ablation System for HFpEF

October 9, 2020—Axon Therapies announced positive interim results for their Satera ablation system from the company’s first-in-human (FIH) clinical study of splanchnic ablation for volume management (SAVM). Sanjiv Shah, MD, reported at a late-breaking trial session at the virtual 2020 Heart Failure Society of America meeting, held virtually September 30-October 6, 2020.

The FIH study evaluated 11 patients with heart failure with preserved ejection fraction (HFpEF) treated using the Satera ablation system. Interim data were presented on 1- and 3-month follow-up postprocedure. Study endpoints included a composite safety index, New York Heart Association (NYHA) heart failure classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and a 6-minute walk test.

All 11 patients achieved procedural success. No device- or procedural-related serious adverse events were reported, according to Axon. At both 1- and 3-month follow-up, significant improvement was observed for:

  • NYHA classification (P < .05)
  • KCCQ score (43 vs 64, P < .05; and 43 vs 79, P < .05, respectively)
  • 6-minute walk test (293 vs 342 m, P < .05; and 293 vs 347 m, P < .05, respectively)

A significant reduction in NT-proBNP at 3-month follow-up (1,292 vs 627 pg/mL; P < .05) was also reported.

“The SAVM procedure selectively blocks the neural pathway carrying signals from the chronically active sympathetic system to the splanchnic vascular bed, causing selective venodilation, improved venous compliance, and ultimately restoring appropriate volume balance within the circulation,” commented Dr. Shah in the company’s announcement. Dr. Shah is the Director of the Heart Failure with Preserved Ejection Fraction program at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

“As physicians, we are often limited in our ability to adequately decongest heart failure patients and prevent excessive increases in pressure during exertion. Although research has shown that inappropriate volume redistribution is a major contributor to functional limitations and outcomes, no interventions targeting this mechanism have existed until now,” said Dr. Shah.

Axon also announced it has begun initiation of REBALANCE-HF, a prospective, randomized, sham-controlled, double-blinded feasibility investigational device exemption trial. The study will begin in early 2021 and enroll 80 patients at up to 20 sites to assess the safety and efficacy of SAVM using the Satera ablation system in HFpEF patients.

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