Coronary heart disease (CHD), or coronary artery disease (CAD), is the leading cause of death globally. In the United States, CHD is the leading cause of death in adults, accounting for nearly one-third of the total deaths in individuals over the age of 35 years old. Modern advancements in CHD treatment have shown improvement in these concerning statistics, which is most noticeable during the decade of 2003 to 2013 when the annual death rate declined 38.0%1.
Atherosclerosis is the reason for clogging of the coronary artery, defined as the buildup of cholesterol and fatty deposits (plaque) within the lumen of the artery, thereby restricting blood flow. A commonly used interventional procedure for CHD is generally called an angioplasty, more specifically a percutaneous coronary intervention. At a very basic level, a stent is guided through an inserted catheter running through an artery of the groin to the target vessel occlusion site. Once in the proper location where the plaque buildup is located, the stent is implanted via expansion and the catheter is removed2. Modern stents are coated with a drug that reduces pathological and vascular remodeling that thickens the vascular wall from eliciting the body’s immune response. Stents used in today’s operation are highly engineered medical implants with decades of work fine-tuning the optimal geometrical shape, effective drug coating, sterilization techniques, implantation procedure, among other components3.
A recent innovation has initiated investigative approaches into degradable polymers because they are metabolized by the immune response at an expected rate via material engineering. These degradable polymers can be loaded with the desired drug so the dosage profile overtime may be manipulated. Furthermore, new coating techniques allow for the drug to specifically target the contacted blood vessel endothelial cells3.
Class III devices such as cardiovascular stents are needed for treating serious threats to public health. Changes are inevitable as technology advances and knowledge of the factors associated with these devices become understood. However, the quality and regulatory standards for manufacturing such high-risk devices shall always have the highest importance and attention. A robust, well-developed foundational Quality Management System (QMS) shall easily incorporate the compliance needs of all QA/RA enforcing bodies. The experts at EMMA International have a plethora of knowledge across multiple sectors of MedTech that consistently proves to be useful in grasping fundamental operations, procedures, and documentation required for maintaining an effective and adaptable QMS. Give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can help will all things quality and regulatory.
[1] Sanchis-Gomar, F., Perez-Quilis, C., Leischik, R., & Lucia, A. (2016). Epidemiology of coronary heart disease and acute coronary syndrome. Annals of Translational Medicine, 4(13), 256–256. Retrieved on 27 July 2021 from: https://doi.org/10.21037/atm.2016.06.33
[2] Cleveland Clinic (2019) Cardiac Catheterization & Coronary Angioplasty and Stent (Interventional Procedures).Retrieved on 27 July 2021 from: https://my.clevelandclinic.org/health/treatments/16833-cardiac-catheterization–coronary-angioplasty-and-stent-interventional-procedures
[3] Elsevier Science & Technology, edited by Gerald Wall, et al. (2017) Functionalized Cardiovascular Stents. Retrieved on 27 July 2021 from: https://ebookcentral.proquest.com/lib/wayne/detail.action?docID=5051423.
