Extraordinary sampling yield compared to standard device in bench testing. Sampling Performance Benchmarks
Clinical Results - PULSE multicentre trial Proven success in challenging biopsies of axillary lymph nodes
Percentage of patients with one, two or three risk parameters 6
Sampling performance in bench model
96% success rate for tissue sampling from axillary lymph nodes with ≥1 major risk parameter (48/50 patients) 6
6% (3/50)
800 700 600 500 400 300 200 100 0
32% (16/50)
62% (31/50)
299% greater mean sample weight with FlexiPulse compared to standard CNB 4
Risk parameters:
One Two Three
Major risk parameters defined as: lymph node (LN) proximity to vessel <5 mm, LN proximity to muscle <5 mm, LN proximity to thoracic wall <5 mm, LN size <10 mm.
Multiple samples were obtained from a single insertion
Pulses shown to optimise needle control
14G FlexiPulse 14G CNB
In 63% of cases (73/115), multi-sampling, i.e. more than one sample per single insertion, was performed by the operator 5
Pulses facilitated control during needle insertion in 87% of cases (100/115) 5
87%
63%
Adapted from Thill et al., 2021. 4 Difference was significant (p<0.0001) Pre-clinical study to benchmark NeoNavia needles against standard biopsy needles. Sampling tests were performed in the most commonly used tissue model (turkey breast) in a test box arrangement. Thirty samples were obtained with the 14G FlexiPulse and comparison 14G standard core needle biopsy needle (BD Achieve), respectively. Studen ´ ts t-test, significance level of 5% (two-sided test), was used for analysis.
Interim results from PULSE (NCT03975855), a prospective, single-arm multicentre study evaluating performance characteristics of NeoNavia FlexiPulse in adult female patients with clinically/sonographically suspicious axillary lymph nodes.
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