Running head: Medical Device Research Project 1
Medical Device Project 4
Medical Devices- Research Project
IT 597 Sec.& Priv. Of Med. Dev
The research will be focused on the approval and the role of a catheter in health care services. A catheter is normally a thin tube that is made from a variety of medical grade materials and is used in different surgical procedures but alongside other medical devices. Among the functions include but not limited to correcting abnormal heart rhythms.
The research will focus on catheters used in surgical procedure with a recently approved complete catheter medical device set. The specific medical device product is ‘The Arctic Front Advance™ and Arctic Front Advance Pro™ and The Freezor Max™ Cardiac Cryoablation Catheters – P100010/S098’. The catheter was officially approved by the Food and Drug Authority (FDA) on 23rd June 2020. There are certain unique features of the device in both the available customizations and functions. The medical equipment is used as a whole set which comprises of various devices but used together as a complete catheter. Each of the devices has a distinct function but is used in a single procedure and all the devices in the set are interdependent.
The medical device set was developed to treat the atrial fibrillation (AF) set where the patient experiences abnormal heart rhythms characterized by fast and irregular heartbeats. The Artic Front Advance Pro Cardiac Cryoablation and the Arctic Front Advance catheters are used in inserting balloon tubing through the veins to the heart which is then inflated at the opening of the vein draining blood from the lungs to the heart. The doctor sends cold air to the balloon to freeze the heart tissue thus blocking abnormal electric signals responsible f abnormal heart rhythm. The cold air comes from the CryoConsole which was part of the device set that was approved together with the catheter product. In cases where the two Arctic Front catheters do not reach the targeted part of the body, the Freezor Max Cardiac Cryoablation Catheter is used. This is the reason the three catheters are classified as a single medical device product and was approved as a single product (Food and Drug Authority, 2021).
The medical use of the catheters is when treating patients with persistent AF or paroxysmal AF of less than duration of six months. The procedure is to be used if the medical condition does not respond to medicine. However, the device should not be used in patients with clots or tumors inside the heart, blood thickening disorder or infections in the bloodstreams (Food and Drug Authority, 2021).
In the report, different aspects of the medical device will be explained in detail. First, an overview of the history of catheters and their role in improvement of health care services will be provided. This will provide a foundation to the discussion on why the approval of this specific catheter is necessary. Also, a brief summary of atrial fibrillation (AF) will be provided as a problem that the approved medical device seeks to solve. The expected impact of the new medical device will be explained at length and possible advance events that may be contributed by the use of the device along the safety measures put in place to mitigate such risks. In addition, the safety and quality features of the device will be outlined in the report and an analysis of the relationship between the device and improvement of patient outcome.
Food and Drug Authority (2021). 2020 Device Approvals. https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals
Food and Drug Authority (2021). The Arctic Front Advance™ and Arctic Front Advance Pro™ and The Freezor Max™ Cardiac Cryoablation Catheters – P100010/. https://www.fda.gov/medical-devices/recently-approved-devices/arctic-front-advancetm-and-arctic-front-advance-protm-and-freezor-maxtm-cardiac-cryoablation
Freeman, J. V., Shrader, P., Pieper, K. S., Allen, L. A., Chan, P. S., Fonarow, G. C., … & Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) I & II Investigators and Patients. (2019). Outcomes and anticoagulation use after catheter ablation for atrial fibrillation. Circulation: Arrhythmia and Electrophysiology, 12(12), e007612.
Kalla, M., Sanders, P., Kalman, J. M., & Lee, G. (2017). Radiofrequency catheter ablation for atrial fibrillation: approaches and outcomes. Heart, Lung and Circulation, 26(9), 941-949.
Liang, J. J., Frankel, D. S., Parikh, V., Lakkireddy, D., Mohanty, S., Burkhardt, J. D., … & Nguyen, D. T. (2019). Safety and outcomes of catheter ablation for atrial fibrillation in adults with congenital heart disease: a multicenter registry study. Heart Rhythm, 16(6), 846-852.
- Analysis of the medical device of your choice (see Topic Proposal). The document should be 10 pages long and address the topics put forward in your proposal. Include images of the device and cite them. Include at least 5 citations.
- A 5-minute presentation about the security and privacy of your selected medical device. Make a PPT for this.