FDA’s device classification distinguishes drug-eluting (drug-coated) stents from bare-metal stents. A coronary drug-eluting stent (Product Code NIQ) is defined as “a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis”. In short, these stents function like vascular scaffolds but carry a pharmacologic agent to prevent vessel renarrowing.

Intended Use of Drug-Coated (Drug-Eluting) Stents

Both devices are coronary stent scaffolds designed to be placed via a delivery catheter into a coronary artery (or a treated graft) to maintain vessel lumen patency and inhibit restenosis by releasing a drug locally at the treatment site. One version is a metal scaffold with a drug coating, and the other is an absorbable scaffold with a drug coating that gradually dissolves after performing its function

Intended use:

A coronary drug-eluting stent is indicated as a metal scaffold with a drug coating that is placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen of the vessel. The drug coating is intended to inhibit restenosis of the treated artery.

Device Description:

A coronary drug-eluting stent is a metal scaffold medical device typically constructed as a finely woven mesh tube that is designed to be delivered through a catheter to a coronary artery or saphenous vein graft. Once positioned across a narrowed segment of the artery, the stent is expanded (often via balloon expansion) to provide mechanical support to the vessel, thereby maintaining luminal diameter and restoring blood flow. The stent’s surface is coated with a pharmacologic agent that is released locally into the arterial wall over time to inhibit neointimal hyperplasia and reduce restenosis following percutaneous coronary intervention.Key features typically include:

• Metallic scaffold (e.g., cobalt-chromium or similar alloys)
• Drug-eluting polymer coating carrying an anti-proliferative agent (e.g., sirolimus, everolimus, etc.)
• Designed for percutaneous delivery and deployment at coronary stenotic lesions
• Intended to be in place permanently after implantation.

Absorbable Coronary Drug-Eluting Stent

Intended use:

An absorbable coronary drug-eluting stent is indicated as an absorbable scaffold with a drug coating that is placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen of the vessel. The drug coating is intended to inhibit restenosis, and after providing mechanical support and drug delivery, the scaffold gradually dissolves and is absorbed by the body.

Device Description:

An absorbable coronary drug-eluting stent is an absorbable scaffold that serves the same fundamental purpose as a traditional drug-eluting stent but is constructed from bioresorbable materials that gradually dissolve and are absorbed by the body after fulfilling their support function. The scaffold is delivered via a catheter into the coronary artery or saphenous vein graft across a target lesion. Like traditional DES, it is coated with a drug-eluting formulation to locally release an anti-restenotic agent, helping to inhibit neointimal proliferation during vessel healing. Over time the scaffold loses mechanical integrity and is resorbed, potentially reducing long-term foreign material in the vessel.Key features typically include:

• Bioresorbable scaffold structure (polymeric or biodegradable metal materials)
• Drug-eluting coating to reduce restenosis
• Designed for temporary mechanical support followed by gradual absorption
• Delivered percutaneously and placed across the target coronary lesion.

Performance Testing (Analytical) for Drug-Coated (Drug-Eluting) Stents:

• Mechanical / Structural
• Radial strength
• Chronic outward force
• Recoil / foreshortening
• Flexibility and trackability
• Fatigue / durability
• Expansion and delivery performance
• Dimensional & Material Characterization
• Scaffold geometry measurements
• Surface finish / coating uniformity Material composition DSC)
• Drug Coating / Release
• In vitro drug release kinetics
• Drug content uniformity
• Polymer performance (if polymer carrier used)
• Corrosion / Biocompatibility Predictors
• Corrosion resistance (for metallic scaffolds)
• Particulate shedding
• Hemocompatibility predictors
• Delivery System Testing
• Introduction and retraction forces
• Crossability / pushability
• Sheath compatibility and integrity
• Animal Performance Testing
• Drug Characterization(Toxicology Study)
• Pharmacology Testing_Bioavailability/Pharmacokinetic Study
• Sterilization Study
• Shelf Life Study
• MR Safety (if claimed)
• Biocompatibility_ISO 10993

Clinical Testing:

Required