Absorb GTi Bioresorbable Vascular Scaffold System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM FDA PMA
- Generic Name
- Absorbable coronary drug-eluting stent FDA PMA
Identifiers
- PMA Number
- P150023 FDA PMA
- FDA Product Code
- PNY FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Absorb GTi Bioresorbable Vascular Scaffold System is an absorbable coronary drug-eluting stent, classified as a Class III medical device. It is designed to provide temporary structural support to coronary arteries, facilitating improved luminal diameter in patients with ischemic heart disease caused by de novo native coronary artery lesions measuring between 2.5 mm and 3.75 mm in diameter and up to 24 mm in length.
This system is intended for single-use in interventional cardiology settings and is supplied sterile. It is regulated under an FDA Premarket Approval (PMA) and is not MRI-safe. The scaffold is bioresorbable, intended to degrade over time while maintaining vessel patency. Authorized sizes and configurations are specified in the accompanying instructions for use.
Frequently asked questions
What is the primary purpose of the Absorb GTi Bioresorbable Vascular Scaffold System in clinical practice?
The Absorb GTi Bioresorbable Vascular Scaffold System is designed to provide temporary structural support to coronary arteries, helping to improve blood flow by maintaining an open lumen in patients with ischemic heart disease caused by specific de novo native coronary artery lesions. It is intended for use in patients with lesions measuring between 2.5 mm and 3.75 mm in diameter and up to 24 mm in length, aiming to restore and sustain vessel patency while the scaffold gradually degrades over time.
Is the Absorb GTi Bioresorbable Vascular Scaffold System intended for reuse, or is it meant for single-use only?
The Absorb GTi Bioresorbable Vascular Scaffold System is explicitly intended for **single-use** in interventional cardiology settings. This is clearly stated in the device description, ensuring it remains sterile and uncontaminated for one-time clinical application.
What are the authorized vessel diameter and length ranges for the Absorb GTi Bioresorbable Vascular Scaffold System?
The system is authorized for use in coronary artery lesions with diameters between **2.5 mm and 3.75 mm** and a maximum length of **24 mm**. These specifications are outlined in the device’s intended use and regulatory approval, ensuring compatibility with specific patient anatomies.
How is the Absorb GTi Bioresorbable Vascular Scaffold System supplied, and what does this imply for handling?
The system is supplied **sterile**, which means it is pre-packaged and ready for immediate clinical use without additional sterilization. This ensures safety and reduces the risk of contamination during deployment, though it also implies that the device must be handled according to sterile procedures to maintain its integrity.
Can the Absorb GTi Bioresorbable Vascular Scaffold System be used in patients who require MRI scans, or does it have any MRI-related restrictions?
The device is **not MRI-safe**, meaning it should not be used in patients who require magnetic resonance imaging (MRI) due to potential risks associated with the scaffold’s materials or structural composition. Clinicians should verify patient imaging needs before deployment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: The Industry's #1 Learning Management System | Absorb LMS Software
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150023 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular Inc.
- FDA Applicant
- Abbott Vascular, Inc.
Sources (1)
- FDA PMA P150023 24 fields · synced Sep 18, 2026