Summary of benefits for XPress BCD™ Mechanical Breast Compression

1. Mechanical compression of the breast with XPress BCD™ following stereotactic-guided breast biopsy is a safe and effective alternative to standard manual breast compression. The incidence of breast hematomas detected immediately following mechanical compression (7.5%) with XPress BCD™ in a FDA monitored clinical study of 120 procedures reduced hematomas 70% compared to standard mechanical compression (25.4% to 43% in large recent historical control studies)(3,5) . Additionally hematomas were reduced in size by 50% relative to the same large control groups. 

2. No clinically significant hematomas or infections were noted in the clinical study population. 

3. Mechanical compression with XPress BCD™ provides labor savings of approximately eleven minutes per biopsy. Although medical staff is required to monitor patients while patients remain in compression, medical staff is freed up to begin room turnover and attend to other duties. Mechanical compression with XPress BCD™ diminishes direct blood contact and importantly exposure to respiratory pathogens through decrease in the time spent in close patient contact during post biopsy-site compression relative to standard manual compression. 

4. Mechanical compression of the breast with XPress BCD™ eliminates the ergonomic difficulties attendant post breast biopsy manual compression for labs that use prone biopsy platforms and apply post biopsy compression while their patients remain on the biopsy tables. Prone biopsy table designs require medical staff to apply sustained (ten or more minutes) of manual pressure on the breast biopsy site with their compressing hand held off axis to their torso and above their shoulder. Mechanical compression with XPress BCD™ is firm, tireless and is not subject to human ergonomic difficulties or to unavoidable human variability and fatigue. (CSSP) 

5. Mechanical compression of the breast with XPress BCD™ ensures rapid and accurate direct compression of all potential sites of post biopsy bleeding including the skin incision site, needle tract and biopsy cavity through the maintenance of the collinearity of these sites during post biopsy mechanical compression. In an effort to avoid the ergonomic difficulties of breast compression encountered while patients remain on their prone stereotactic-biopsy tables, many interventional suites choose to move their patients off of the biopsy tables for compression of the biopsy sites with the patient supine on a stretcher. With this maneuver, the maintenance of the collinearity of all of potential bleeding sites and consequently the accuracy of comprehensive post biopsy site compression, is necessarily lost due to the attendant 180 degree breast rotation from prone or upright position during biopsy procedures to a supine position on a stretcher. Additionally, this work flow necessarily results in a delay in application of compressive force to the post biopsy sites during patient transfer. With XPress BCD™ collinearity is always maintained and mechanical breast compression is applied in seconds after termination of the biopsy in prone and upright biopsy applications. 

6. Mechanical compression of the breast with XPress BCD™ is well tolerated with 97% of patients rating their experience with mechanical compression from “good to excellent”. Although there is no published literature to compare patient perceptions of mechanical breast compression to standard manual compression of the breast after stereotactic-guided, or other minimally invasive biopsies, it is interesting to note that patients have reported improved satisfaction with mechanical compression of the groin after femoral arterial catheterization relative to standard manual compression. In a study comparing mechanical clamp compression versus manual compression of the groin, 70% (95/136) of patients with previous catheterizations stated an “explicit preference for (use of) the mechanical compression”.(29)  

7. Although the radiology literature is inconsistent and often subjective, usually relying on patient self-reporting by phone without imaging follow-up, mechanical compression with XPress BCD™ demonstrated a very low rate of delayed hematoma formation; 3.3% on follow up out to 7 days following biopsy. (1,3) Additionally, no patients (0/30) had hematomas detected at the time of required pre-surgical mammographic localization procedures at an average of 4 weeks post biopsy. 

8. In addition to significant labor cost savings with each use, XPress BCD™ is an extremely durable reusable device requiring only a disposable low-cost sterile latex-free covering for reuse 

9. If approved, further study of the safety of the use this device for patients who may benefit from maintenance of anti-thrombolytic therapy is anticipated. It is hoped that validation of the safety and efficacy of XPress BCD™ in that clinical setting will lead to acceptance in the general medical community (cardiologists, radiologists and breast surgeons) and may diminish the costs and risks of “bridge therapy” or risks of discontinuing anti-thrombolytic therapy all together including the well documented associated increased risk of acute coronary syndrome and stroke.