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1. What is Coronary Stents?
Coronary stents are the tubular metallic devices that are expandable and can be used in the clogged
arteries of the patients that are suffering from an underlying arthrosclerosis condition. The procedure of
revascularization is also known as the percutaneous coronary intervention or coronary angioplasty after
the introduction of the stent. After the safe placement of coronary stents, the coronary dissection and
the vascular recoil are eliminated because of the expandable and metallic meshwork of the stent, which
prohibits the negative remodeling. The first coronary stent was designed in the 1980s, since then it has
shown improvement in the shape, structure and the material that is used for designing them.
What is Coronary Stents Working?
Coronary stents are the small, wired mesh tubes that allow the widening of a clogged artery and
restoration of adequate blood flow to the heart. During the procedure, the cardiologist places the stent
over a long, thin tube with a balloon tip called as a catheter and allows the insertion into the groin area
or the arm region. After the stent reaches the clogged artery, the cardiologist will allow inflation of the
balloon for expanding the stent. After the stent reaches the appropriate size for widening the clogged
artery, the doctor will allow deflation of the balloon and its removal. However, the stent will be staying
in the place permanently for propping open the artery and for decreasing the chances of narrowing
down again.
How many types of Coronary Stents?
Bare-Metal Stents
Bare metal stents are made of tiny mesh wired tubes, which allow the widening of the clogged artery
but do not have a coating of the polymer or drugs that helps to avoid re-blockage of the arteries. These
types of stents can be used in patients that are allergic to certain polymers or do not require drugs that
are eluted from the drug eluting stents.
Drug-Eluting Stents
A drug-eluting stent is a bare-metal stent which has a coating of the polymer and allows the gradual
release of the drugs over a period of time when the re-blocking of the arteries is about to take place.
The drug eluting stents help in order to minimize the chances of the artery blockage from happening
again. There are two subcategories of drug eluting stents namely:
Permanent Polymer Drug-Eluting Stent
In this particular type of stent, the polymer is placed onto the stent permanently even after the release
of the entire drug permanently.
Bioresorbable Polymer Drug-Eluting Stent
In this type of stent, the polymer and the drug coatings are absorbed fully by the body shortly after the
drug has been released fully. This tends to promote better healing after elimination of the long term
polymer exposure.
What is Coronary Stents Regulatory?

2. Coronary stents are placed in class III of product classification by the U.S. FDA. For class III devices, the
sponsor must implement a Quality Management System (QMS) that meets FDA Quality System
Regulation (QSR). It requires to confirm to the clinical studies. An Investigational Device Exemption (IDE)
must be applied if clinical studies are required and sponsor should develop clinical trial protocol and
conduct study. Manufacturer must prepare and submit a PMA Premarket Notification application and
pay required fee. FDA issues PMA approval letter and is posted online. At this time, the sponsor must be
in full compliance with QSRs.