Recruitment and blocking properties of the CardioFit stimulation lead

Tamar Ahilea Anholt1, Shai Ayal, Joshua A Goldberg

  • 1BioControl Medical Ltd, Yehud 56100, Israel.

Insights

The CardioFit system shows promise for treating congestive heart failure by selectively stimulating vagal nerve fibers. This therapy demonstrated significant unidirectional attenuation of A-fiber action potentials in preclinical tests.

Area of Science:

  • Biomedical Engineering
  • Neuroscience
  • Cardiovascular Research

Background:

  • Congestive heart failure (CHF) is a serious condition with limited therapeutic options.
  • Vagal nerve stimulation is being explored as a novel treatment for CHF.
  • The CardioFit system aims to selectively target cardiac vagal fibers.

Purpose of the Study:

  • To characterize the recruiting and blocking properties of the CardioFit stimulation lead (CSL).
  • To evaluate the CSL's ability to selectively stimulate efferent cardiac vagal fibers while minimizing off-target activation.
  • To inform optimal parameter settings for the CardioFit system in clinical trials.

Main Methods:

  • The CardioFit stimulation lead (CSL) was tested on isolated porcine vagus nerves.
  • Nerves were maintained at elevated temperature in artificial cerebrospinal fluid.
  • Charge-balanced, quasi-trapezoidal pulses were used to measure nerve activation and blocking thresholds.

Main Results:

  • A 63% ± 13% mean unidirectional attenuation of A-fiber compound action potentials was achieved.
  • This effect was observed in 8 out of 9 tested nerves at 3.0 ± 0.8 mA.
  • The activation thresholds for A- and B-fibers were determined to be 0.3 ± 0.17 mA and 2.5 ± 1.1 mA, respectively.

Conclusions:

  • The CardioFit stimulation lead demonstrates effective selective vagal nerve fiber recruitment and blocking.
  • These findings support the potential of the CardioFit system as a therapy for congestive heart failure.
  • The study provides crucial data for optimizing CardioFit system parameters in the INOVATE-HF clinical trial.

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