Drug Eluting PTCA Catheter

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I3CGlobal IVDR, FDA 510k

FDA PMA and CE Marking for Drug Eluting PTCA Catheter

A percutaneous transluminal coronary angioplasty (PTCA) catheter – a balloon angioplasty catheter – is defined by FDA classification (Product Code LOX) as “a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end”. In practice, this means a PTCA catheter is a balloon-tipped catheter used to dilate coronary artery blockages. PTCA balloon catheters are Class II devices (requiring 510(k) clearance).

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Drug Eluting PTCA Catheter
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FDA PMA for Drug Eluting PTCA Catheter Device Code and Regulation Number

S. No Product Code Device Class

1

          OOB

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

3

Drug Eluting PTCA Catheter

A Drug-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter is a combination product intended for balloon dilatation of hemodynamically significant stenoses in coronary arteries in patients with evidence of myocardial ischemia for the purpose of improving myocardial perfusion.

The drug coating is delivered to the vessel wall during balloon inflation as part of the angioplasty procedure and is intended to inhibit restenosis and maintain vessel patency following treatment.

Description:

A PTCA balloon catheter is a single-use, over-the-wire or rapid-exchange catheter constructed of polymeric materials and advanced to the target lesion over a guidewire. The balloon is available in multiple diameters and lengths to accommodate varying vessel sizes and lesion lengths. When inflated, the balloon applies controlled radial mechanical force to dilate the stenotic segment and restore vessel lumen patency. For drug-coated configurations, the drug coating is intended as an adjunct to the mechanical dilatation and is designed to reduce restenosis and help maintain vessel patency following the procedure.

Performance Testing (Analytical) for PTCA Catheters:

  • Dimensional & physical verification
  • Simulated use (anatomic tracking)
  • Balloon mechanics: burst, fatigue, compliance, inflation/deflation
  • Shaft tests: bond strength, kink, torque
  • Radiopacity
  • Fluid handling: contrast flow, burst/leak tests
  • Coating tests (if coated)
  • Particulate evaluation
  • In-stent / constrained environment tests (if labeled)
  • Drug / Coating (Combination Product) Testing
  • Drug identity & content
  • Drug identity confirmation
  • Drug content per balloon (µg/mm² or total µg/device)
  • Dose uniformity (within balloon + between lots)
  • Drug stability (real-time + accelerated)
  • Drug release / elution testing
  • In-vitro drug release profile (time vs % released)
  • Drug transfer efficiency (how much transfers to tissue vs lost)
  • Coating performance during use
  • Coating integrity after simulated tracking + inflation
  • Drug loss during delivery (before inflation)
  • Particulate shedding (size + count + mass)
  • Excipient characterization (if used)
  • Chemistry characterization (extractables/leachables)
  • Toxicological Risk Assessment (TRA) (ISO 10993-17)
  • Biocompatibility Testing (ISO 10993)
  • Animal (In Vivo) Testing (If device claims ISR, AMI, bypass graft)
  • Pharmacokinetics (PK) / Toxicology
  • Sterilization Study

Clinical Study:

Required

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