Final data set from NeoDynamics’ PULSE study presented at The SBI Breast Imaging Symposium
The final data set from NeoDynamics’ PULSE study shows favorable safety and efficacy profile of NeoNavia for ultra-sound guided biopsies in the axillary lymph nodes. The data are being presented at The SBI Breast Imaging Symposium this week.
The conference, taking place on May 4-7 2023, at the Gaylord National Resort & Convention Center in National Harbor, Maryland, is the World’s Largest Breast Imaging Conference.
NeoDynamics’ PULSE study is a German prospective multi-center study (ClinicalTrials.gov ID: NCT03975855) designed to document the performance of the NeoNavia biopsy device in the axillary lymph nodes on 138 enrolled patients. Professor Marc Thill, PhD, has been principal investigator. An electronic presentation of his abstract is presented at the Symposium.
The key data of the finalized study are:
- Success rate for biopsies from the lymph node was 93 % (128/138). (“high success rate”)
- Hematoma in the axilla occurred in 1.4% (2/138) of patients. Pain in the axilla was reported in 2.9 % (4/138) of patients. (“low rate of adverse events”)
- The pneumatic pulses promoted control during needle insertion in 89% (123/138) and stabilization of target lesion during needle insertion in 88% (122/138) of patients.
- 46% (64/138) of patients presented with at least one of four major risk parameters (lymph node diameter <10mm, proximity to blood vessel/muscle/thoracic wall <5mm) (“broad patient cohort”)
The study has demonstrated that pneumatic pulses promoted needle control and stabilization of target lesions during insertion of the needle and that it was possible to obtain multiple samples with a single insertion.