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Single Pass Device Used in Case

The problem

Each year, millions undergo solid organ biopsy procedures, occasionally encountering adverse events linked to needle size and patient risk factors like blood disorders or anticoagulation medication. Identifying patients prone to bleeding complications remains challenging. Current strategies, including medication adjustments, hemostatic agents, and prolonged pressure bandaging post-procedure, aim to minimize risks. Yet, these methods fall short, with hemorrhage, transfusions, and even fatalities still occurring. 

Traditional Methods Downfalls

Pub Med Data from 156 articles, 371,947 biopsy procedures:​

Poor outcomes are too common

Somerville, P., et al. "Bleeding risk after biopsy." AJR 191.4 (2008): 1194-7.

Aaltonen, S., et al. "Outpatient Kidney Biopsy." Nephron 144.1 (2020): 14-20.

Altindal, M., et al. "Safety in AA Amyloidosis." Nephron 131.1 (2015): 17-22.

Rianthavorn, P., et al. "Pediatric Kidney Biopsy Safety." Nephrology 19.3 (2014): 143-8.

Charu, V., et al. "Kidney Biopsy & Transfusions." Kidney Int Rep 4.10 (2019): 1435-45.

observatory protocol
Observatory Protocol
too common of a problem
Biopsy Bleeds Increase
Biopsy Bleeds Increase
Biopsy Bleeds Increase

Fig. 1: Timing of Bleeding Events After Any Biopsy Site​

  • Of 52 bleeding events, 37% (19) occurred at biopsy. Events peaked within 24 hours.​

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Fig. 2: Timing of Bleeding Events After Native Kidney Biopsy​

  • Of 17 bleeding events, 41% (7) occurred within 6 hours, representing 0.5% of 1,407 native kidney biopsy patients. Most occurred early.​​​​​

Fig. 3: Timing of Bleeding Events After Liver Biopsy​

  • Of 22 bleeding events, 64% (14) occurred within 2 hours, representing 0.3% of 4,417 liver biopsy patients. Early events were common.

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