Esprit BTK Everolimus Eluting Resorbable Scaffold System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Esprit BTK Everolimus Eluting Resorbable Scaffold System FDA PMA
- Generic Name
- Scaffold, infrapopliteal, absorbable FDA PMA
Identifiers
- PMA Number
- P230036 FDA PMA
- FDA Product Code
- NXW FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Esprit BTK Everolimus Eluting Resorbable Scaffold System is an absorbable scaffold designed for infrapopliteal arterial applications. It is intended to improve luminal diameter in patients with Chronic Limb Threatening Ischemia (CLTI) by providing structural support to the vessel wall during revascularization.
This device is supplied as a single-use, resorbable scaffold system with a maximum scaffolding length of 170 mm and a reference vessel diameter range of 2.5 mm to 4.00 mm. It is intended for use in controlled clinical settings and has received FDA_PMA authorization under PMA number P230036. The system is classified as a Class III medical device under the OpenFDA nomenclature.
Frequently asked questions
What specific part of the leg’s blood vessels is this scaffold designed to treat, and what condition does it address?
The Esprit BTK Everolimus Eluting Resorbable Scaffold System is designed for infrapopliteal arteries, which are the blood vessels located below the knee. It is intended to improve blood flow in patients suffering from Chronic Limb-Threatening Ischemia (CLTI), a severe form of peripheral artery disease that restricts blood flow to the legs, often causing pain, ulcers, or tissue death.
Is this scaffold reusable, or is it meant for single-use only? How does that affect its clinical application?
The Esprit BTK Everolimus Eluting Resorbable Scaffold System is explicitly supplied as a single-use device. This design ensures sterility and safety for one procedure, preventing cross-contamination and reducing the risk of infection. Clinicians must use a new scaffold per patient to comply with medical best practices and regulatory requirements.
What are the available sizes for this scaffold, and how do I determine if it’s suitable for a patient’s vessel?
The scaffold has a maximum length of 170 mm and is designed for vessels with a reference diameter between 2.5 mm and 4.00 mm. To determine suitability, clinicians should measure the patient’s infrapopliteal artery diameter via angiography or other imaging before selection. The scaffold’s absorbable nature also means it resorbs over time, so vessel dimensions post-procedure may influence long-term outcomes.
How should this device be stored, and are there any special handling requirements before use?
Since it is a single-use, sterile device, storage should follow standard medical device protocols to maintain sterility—typically in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until immediate use. Before deployment, clinicians must verify the scaffold’s integrity and ensure compatibility with their delivery system, as resorbable scaffolds require precise handling to avoid damage during implantation.
What distinguishes this scaffold’s regulatory pathway, and how does that impact its availability or use?
The Esprit BTK Everolimus Eluting Resorbable Scaffold System received FDA Premarket Approval (PMA) under PMA number P230036, indicating it underwent rigorous clinical evaluation to demonstrate safety and effectiveness. This approval confirms its classification as a Class III device under OpenFDA, meaning it is subject to strict regulatory oversight. Clinicians should confirm local hospital protocols and insurance coverage, as PMA-approved devices may have specific ordering or procedural requirements.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230036 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P230036 24 fields · synced Sep 18, 2026