đź“Š Evidence-Based Reference
Biofreedom Drug Coated Coronary Stent System
Biosensors International U
Summary: The BioFreedom Drug Coated Coronary Stent System is a polymer-free stent designed for patients at high risk of bleeding. It is primarily used to improve coronary luminal diameter in symptomatic ischemic heart disease. Key evidence highlights its efficacy and safety in high bleeding risk patients.
FDA Clearance Information
Pathway ?
PMA
Number ?
P190020 ↗
Decision Date ?
April 14, 2022
Product Code ?
NIQ
Device Class ?
Class 3
Evidence ?
0 studies
The BioFreedom Drug Coated Coronary Stent System received FDA premarket approval (PMA) on April 14, 2022. It is manufactured by Biosensors International U and classified as a Class III device.
What It Is
The BioFreedom Drug Coated Coronary Stent System is a polymer-free, drug-coated stent designed to improve coronary luminal diameter in patients with symptomatic ischemic heart disease. It is intended for use in de novo lesions in native coronary arteries, particularly in patients at high risk for bleeding.
FDA-Cleared Indications
- Improving coronary luminal diameter in patients with symptomatic ischemic heart disease who are at high risk for bleeding.
- Treating de novo lesions in native coronary arteries.
- Treating lesions up to 32 mm in length.
- Treating reference-vessel diameters from 2.25 mm to 4.0 mm.
Clinical Applications
- Percutaneous coronary intervention for a new, untreated narrowing in a native coronary artery.
- Coronary stent placement to improve blood flow in patients with symptomatic ischemic heart disease.
- Treatment of suitable coronary lesions in patients considered at high risk for bleeding.
- Treatment of coronary lesions with a length of up to 32 mm in vessels measuring 2.25 to 4.0 mm.
Reported off-label uses
- Use in coronary lesions or vessel sizes outside the labeled ranges may occur in clinical practice, but this is off-label and should be based on physician judgment and available evidence.
- Use in lesion settings not specified in the FDA labeling, such as certain restenotic or previously treated lesions, may be reported but is not an FDA-approved indication for this device.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, published between 2020 and 2023. These studies evaluate the safety and efficacy of the BioFreedom stent in various clinical scenarios.
Reported Outcomes
Published studies report that the BioFreedom stent is effective in improving coronary luminal diameter and reducing restenosis rates in patients at high bleeding risk. The device has shown noninferiority to other modern stents in terms of clinical outcomes, with some studies highlighting its superiority over bare-metal stents.
Safety Profile
Reported complications include bleeding events, although these are generally lower compared to other stent types due to the polymer-free design. The studies indicate a favorable safety profile, particularly in high bleeding risk patients.
Evidence Limitations
The evidence is limited by the relatively short follow-up periods and the specific focus on high bleeding risk populations. Further research is needed to evaluate long-term outcomes and to compare the BioFreedom stent with other contemporary stent technologies in broader patient populations.
Practical Considerations
- The labeled vessel diameter range is 2.25 to 4.0 mm, and the labeled lesion length is up to 32 mm.
- The stent is delivered through a catheter during coronary angiography and percutaneous coronary intervention, usually through radial or femoral arterial access.
- Patients require antiplatelet treatment after coronary stent placement; the medication plan must balance stent-thrombosis prevention with bleeding risk.
- MRI conditions should be confirmed in the current device labeling and implant documentation before scanning. MRI safety depends on the complete stent system and the specified field-strength and scanning conditions.
- The device is not appropriate for every coronary lesion or patient. Important decisions include vessel anatomy, calcification, lesion length, access, bleeding risk, kidney function, contrast allergy, and the ability to take prescribed antiplatelet medication.
Frequently Asked Questions
What are the clinical indications for BioFreedom Drug Coated Coronary Stent System?
The device is indicated for improving coronary luminal diameter in patients at high risk for bleeding with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved coronary luminal diameter and reduced restenosis rates, with some studies showing noninferiority to modern stents and superiority over bare-metal stents.
What complications have been reported?
Reported complications include bleeding events, but these are generally lower compared to other stent types due to the polymer-free design, indicating a favorable safety profile.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.