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About Essure

Essure is a birth control implant for non-surgical female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage. The company is based in Whippany, New Jersey.

Essure Headquarter Location

100 Bayer Boulevard

Whippany, New Jersey, 07981,

United States

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Performance of Centargo: A Novel Piston-Based Injection System for High Throughput in CE CT

Apr 5, 2022

Corey A Kemper,1 Casper Mihl,2,3 Bibi Martens,2,3 Michael C McDermott,2,4 Babs MF Hendriks2,3 1Bayer U.S. LLC, Bayer Pharmaceuticals, Radiology R&D, Indianola, PA, USA; 2Department of Radiology & Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands; 3Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands; 4Bayer AG, Radiology R&D, Berlin, Germany Correspondence: Corey A Kemper, Bayer U.S. LLC, Bayer Pharmaceuticals, Radiology R&D, 1 Bayer Dr, Indianola, PA, USA, Tel +1 412 225 3907, Email [email protected] Purpose: To compare an investigational device (MEDRAD® Centargo CT Injection System, “Centargo”) to the currently available MEDRAD® Stellant CT Injection System (“Stellant”), in terms of efficiency, injector performance, and user satisfaction. Patients and Methods: A total of 425 patients at two sites were enrolled; 198 patients in phase one, a randomized study (98 Stellant and 100 Centargo). The second observational phase included 227 patients who were injected with Centargo. Phase one recorded times for setup, disassembly, and patient changeovers. Demographic data, subjective image quality, and injection parameters were collected. Phase two assessed usability via a questionnaire provided to all end-users of both systems (radiographers). Results: Patient changeover times were statistically significantly faster with Centargo (15.4s ± 8.7s vs 53.7s ± 19.6s, p Conclusion: Centargo was able to demonstrate improved efficiency as compared to Stellant while maintaining injector performance and high usability scores. Keywords: power injection, efficiency, time savings, usability, Centargo Introduction The number of contrast-enhanced computed tomography (CT) examinations is increasing all over the world each year. Due to the development of the scanner technology and the availability of Multidetector CT (MDCT), the time to conduct the scan itself has become shorter. 1 Intravenous injection of iodinated contrast media (CM) can aid in visualizing the vasculature, organs, and pathologies. 2 Power injection systems are commonly used for contrast-enhanced CT (CE CT) to achieve consistent flow rates and to allow for control of the injection remotely, outside the scan room. Most common are syringe-based systems, where one or two empty, disposable syringes are filled from CM bottles and saline bags. 3 The injection system mechanically drives a piston forward through each syringe, generating sufficient pressure to administer the programmed injection protocol, which is determined based on a variety of patient and procedure specific factors. 4 While performance of such devices is well-accepted, there are limitations from a workflow efficiency perspective. The time to prepare the CM injection often takes longer than the image acquisition itself. There are “syringeless” systems that instead utilize peristaltic pumps to deliver the fluid, which have been shown to shorten setup and changeover time, 5 , 5 , 6 , 6 , 7 but the performance is not in all aspects comparable to a piston-based system. Maximum pressures can be lower, leading to lower achievable iodine delivery rates, 8 and the pulsatility of the flow is higher. 9 Both of these factors can lead to inferior CM enhancement, which in turn can produce CT images with a reduced diagnostic quality. 4 , 10 , 11 A novel CT injection system has been designed to maintain the fluid delivery advantages of a piston-based system (such as the Stellant CT injection system) but with the highest possible time efficiency, allowing the radiographer to spend less time handling the injector and disposables and more time focusing on the patient. While the technical fluid delivery performance is very similar between this novel injection system and the current piston-based system, 8 the main differences are in the workflow features. These include an addition of a third syringe for CM, a simplified snap-in patient line designed for changing disposables between procedures, and automated features such as automatic priming and automatic refilling to reduce manual preparation time. The aim of this study is to compare the investigational injection system (Centargo) to the currently available Stellant CT injection system, in terms of efficiency, performance, and user satisfaction. Materials and Methods Study Design This was a randomized multi-center, multi-country prospective clinical study, approved by BellBerry Human Research Ethics Committee (Australia) and the medical ethics research committee METC aZM/UM (the Netherlands). The study-outline was posted on with the identifier NCT03875469. The study was performed in accordance with the ICH Good Clinical Practice guidelines. The patient population consisted of adults (≥ 18 years) already referred for a CE CT. All patients provided informed consent. The injection protocols and scanner settings followed the site’s typical practice, which was based on the indication for imaging and any patient-specific needs. No additional injections or scans beyond usual clinical practice were performed. Two centers were participating. First was Medscan Merrylands, an imaging center in Sydney (Australia), focused primarily on cardiac imaging. Their standard CM was iohexol 350 mgI/mL (GE Healthcare) in 200mL bottles. Second was Maastricht University Medical Center, an academic tertiary referral hospital located in Maastricht (the Netherlands). Their standard CM was iopromide 300 mgI/mL (Bayer AG) in 500 mL bottles. The study was designed with two phases, shown in Figure 1 . The first phase was a randomized trial to test Centargo’s time efficiency compared to Stellant, when Stellant is used with a multi-patient (MP) disposable set. Setup time for the MP set, bottle/bag changeover time, patient changeover time, and disassembly time for the MP set were collected. Figure 2 provides an example of the physical interaction steps that were measured using a stopwatch. Figure 1 Study flowchart for phase 1 and phase 2 of the PerCenT study. Figure 2 Overview of the timing process for phase 1 data collection of the study. Light blue dots represent new bottles, and dark blue dots represent new patients. Abbreviations: BC, bottle change; Pt, patient. The minimum sample size for phase one of the study was based on the primary endpoint, which was the time efficiency difference between the two injection systems. Based on a preliminary pilot study conducted in a simulated environment, a time savings of approximately 50% was anticipated, assuming a minimum of ten subjects per day, which is a conservative estimate at high throughput sites. Using the standard deviation (SD) from the Stellant dataset of the bench study, for 90% power, group sample sizes of 98 and 98 would be required. To balance enrolment across sites, group sample sizes of 100 and 100 for this phase were required (50 subjects per group per planned site). The second phase was a prospective observational study of Centargo only, in order to test the overall reliability of the system and create additional time for the radiographers (end-users) to use the injector prior to providing feedback. Across both study phases, adverse events and device deficiencies were collected. Additionally, for each patient, demographic data (height, weight, age, and gender), procedure data (indication, CM type and concentration used, catheter type, and injection site) and timing data were recorded in an electronic case report form. Automatic data collection from the injector logged programmed protocols, pressures, flow rates, and any alerts/errors. Finally, in order to compare the qualitative usability of Stellant and Centargo, radiographers were surveyed on their satisfaction with the two systems after study enrolment completed, based on a pre-defined questionnaire. Each question (listed in Table 1 ) was scored on a scale of 1 (Very Easy) to 5 (Very Hard). Table 1 User Questionnaire Results per Injection System. Radiographers Scored the Ease of Certain Tasks in Patient Preparation on a 1–5 Scale, Where 1 is “Very Easy” and 5 is “Very Hard” Statistical Analysis Descriptive statistics are provided as mean ± SD for continuous variables and absolute and relative frequencies for categorical variables. Comparisons between the groups with the endpoints specified above were performed by using the χ2 test for categorical variables and t-test or Mann–Whitney-U-test for continuous variables as appropriate. Primary endpoint was the total day-time needed for setup (once a day), per patient change time and teardown time. Study design and sample size calculations were done with PASS15 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, P-values are all 2-sided and considered significant when below 0.05. Microsoft Excel for Microsoft 365 MSO (Microsoft Corporation. Redmond, WA, USA) was used in the final analysis. Results Enrolment and Patient Demographics Demographics were similar between the two groups, as shown in Table 2 . Site profiles drove differences in indications, procedure types, and CM used. Medscan completed their phase one enrolment at 100 patients total (50 Centargo, 50 Stellant), and then moved onto phase two, where they enrolled an additional 227 patients. Maastricht enrolled 98 patients in phase one (50 Centargo, 48 Stellant) prior to ending the study early due to the COVID-19 situation in March 2020. Table 2 Patient Baseline Characteristics per Injection System for the Two Study Phases Time Comparison The primary endpoint of the study was measuring workflow efficiency and usability of Centargo vs Stellant. Descriptive statistics for each timing measurement are shown in Table 3 , with corresponding box plots in Figure 3 . Patient changeover times were statistically significantly faster with Centargo (15.4s ± 8.7s vs 53.7s ± 19.6s, p < 0.001). Centargo day-setup times were similar to Stellant (138.1s ± 92s vs 151.8s ± 30.6s, p = 0.33) and end-of-day-disassembly times were significantly slower (60.6s ± 27s vs 17.1s ± 12.9s, p < 0.001). Table 3 Mean Handling Times Recorded for Setup, Disassembly, and Patient Changeover, with (w/) and without (w/o) Bottle Changes Figure 3 Handling time results for each device at each site: (A) setup times from start of the day. (B) Disassembly times from end of the day. (C) Patient changeover times when a bottle change is required to refill the system. (D) Patient changeover times when only a change of the patient line is required. Injection System Performance Injector performance was analyzed on the basis of phase one data, as this allows for balance between the two sites (50 Centargo patients at each site), instead of the data being dominated by Medscan’s phase two enrolment (an additional 227 Centargo patients). Both injectors were used across a broad range of injection sites, procedure types, and flow rates, with two different CM types and commonly used catheters. All injections were completed successfully. Relative distributions of injection sites and catheter types are shown in Figure 4 . As shown in Figure 5 , peak pressure increased with increasing flow rate and CM viscosity (iohexol 350 is higher viscosity than iopromide 300). Figure 4 Intravenous (IV) access information, including IV sites (A) and catheter types (B). Abbreviation: ACF, antecubital fossa.

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  • Where is Essure's headquarters?

    Essure's headquarters is located at 100 Bayer Boulevard, Whippany.

  • What is Essure's latest funding round?

    Essure's latest funding round is Other Investors.

  • Who are the investors of Essure?

    Investors of Essure include VantagePoint Capital Partners.

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