BioSentry™ TRACT SEALANT SYSTEM CLINICAL REVIEW

Real-world clinical data now validates BioSentry™ helps reduce risk of pneumothorax and chest tube insertion rates

  • Recent all comers study published in JVIR demonstrated 80% reduction in chest tube insertion rates when using the BioSentry™ System
  • Similar rates of pneumothorax seen in all comer population

Study Design: Retrospective review of 200 consecutive patients (100 consecutive biopsies were done without any intervention and the next 100 consecutive biopsies done with the BioSentry™ System). Objective was to evaluate use of a self-expanding tract sealant device (BioSentry™) on the rates of pneumothorax (PTX) and chest tube placement.

  • Recent study published in JVIR demonstrated 61% reduction in chest tube insertion in high-risk patients versus standard of care
  • Significant reduction of pneumothorax in high-risk population

Study Design: Retrospective study, comparing patients receiving BioSentry™ device (318) vs control arm (1956) during percutaneous lung biopsy. To adjust for potential selection bias, patients in the treated group were matched 1:1 to patients in the control group using propensity score matching. Objective was to evaluate use of a self-expanding tract sealant device (BioSentry™) on the rates of pneumothorax (PTX) and chest tube placement.

80% REDUCTION
IN CHEST TUBES 3
8
6
4
2
2 %
10 %
BioSentry™
(n = 100)
Standard of Care
(n = 100)
ARR: 8% RRR: 80% p < .05
61% REDUCTION
IN CHEST TUBES 4
32
24
16
8
8.2 %
20.8 %
BioSentry™
(n = 318)
Standard of Care
(n = 1956)
ARR 13% RRR 61% p <0 .0001

BioSentry™ Proven to Significantly Reduce Pneumothorax.1

>50% REDUCTION
IN PNEUMOTHORAX
80
60
40
20
85 %
69 %
BioSentry™
(n = 126/150)
Per Protocol Population
Standard of Care
(n = 94/137)
ARR 16% RRR 52% NNT:6 p=0.002
67% REDUCTION IN
CHEST TUBES
12
9
6
3
4 %
11 %
BioSentry™
(n = 6/170)
Intent to Treat Population
Standard of Care (n = 18/169)
ARR 7% RRR 67% NNT:14

The BioSentry™ tract sealant system is Proven to Reduce the Pneumothorax Cascade.1

35% DECREASE
IN HOSPITAL ADMISSIONS
20
15
10
5
9 %
14 %
BioSentry™
(n = 16/170)
Standard of Care
(n = 23/169)
ARR: 5% RRR: 36% NNT:20
45% REDUCTION
IN RADIOGRAPHS
40
30
20
10
17 %
31 %
BioSentry™
(n = 29/170)
Standard of Care
(n = 52/169)
ARR 14% RRR 45% NNT:7

ARR = Absolute Risk Reduction

RRR = Relative Risk Reduction

NNT = Number Needed to Treat

The BioSentry™ tract sealant system has an excellent safety profile - there were no clinically significant complications associated with its use.1

Fewer BioSentry™ tract sealant system patients had an anticipated procedure- or device-related adverse event compared to controls (25% vs 44%).

Neither air embolism, emphysema, altered lung function, infection, puncture site irritation or bruising, nor inflammatory reaction were associated with BioSentry™ tract sealant system.