Sherlock 3CG+™ Display - CE

1. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD’s indications and instructions for use.
   
2. Company sponsored study comparing Sherlock 3CG™ TCS on adult patients against historical PICC placement standard of care for blind insertion followed by a chest X-ray (CXR) for tip confirmation. Data on file.
   
3. Reduced cost based on post-hoc exploratory analysis suggesting the costs between the two placement processes are different. 

The Sherlock 3CG+™ tip confirmation system (TCS) is indicated for navigation and positioning of central venous access devices (CVADs) of at least 2 Fr in size.
   
   The Sherlock 3CG+™ TCS provides real-time catheter tip location information by using catheter navigation technology along with the patient’s cardiac electrical activity and is indicated for use as an alternative method to chest X-ray Sherlock 3CG+™ TCS and fluoroscopy for CVAD tip placement confirmation of approaches from the superior vena cava.


   
   In adult patients and in adolescents (greater than 12 through 21 years of age), the Sherlock 3CG+™ TCS can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports and hemodialysis catheters; in children (greater than 2 to 12 years of age), in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), the Sherlock 3CG+™ TCS can be used with PICCs and with centrally inserted central catheters (CICCs). In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD’s indications and instructions for use.


   
   Limiting but not contraindicated situations for this method are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion, the use of an additional method is required to confirm catheter tip location.
   
4. In a clinical study, 332 subjects received vascular access devices in the form of PICCs, ports and tunneled catheters of which 114 received PICCs. Placement of PICCs were deemed acceptable in 99.1% (113/114) of the subjects. Pittiruti M (2010) evGuide-Sapiens™ TLS Post-market Clinical Study Report. Catholic University Hospital.
   
5. Pittiruti M, Bertollo D, Briglia E, et al. The Intracavitary ECG Method for Positioning the Tip of Central Venous Catheters: Results of an Italian Multicenter Study. The Journal of Vascular Access. 2012;13(3):357-365. doi:https://doi.org/10.5301/jva.2012.9020

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.



BD-67856 (11/23)