Tryton Side Branch Stent
PMA P150039
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP150039 | Date21 Feb 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- STENT, CORONARY
- PMA Number
- FDA Product Code
- MAF
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Tryton Side Branch Stent is a coronary stent designed to improve the luminal diameter of side branches in de novo native coronary artery bifurcation lesions (Medina Classification 1.1.1; 0.1.1; 1.0.1). It is intended for use in side branches with a diameter stenosis of ≥50% and lesion length ≤5.0 mm, alongside reference vessel diameters of ≥2.5 mm to ≤3.5 mm in the side branch and ≥2.5 mm to ≤4.0 mm in the main branch, when used in conjunction with balloon-expandable drug-eluting coronary stents in the main branch.
This device is deployed via a single-wire, balloon-expandable stent delivery system and features an open architecture to accommodate conventional drug-eluting stents in the main vessel. It is supplied sterile and intended for single-use. The Tryton Side Branch Stent holds an FDA Premarket Approval (PMA P150039) and is classified as a Class III medical device under the FDA’s regulatory framework.
Questions
AI-generated answers, 18 Sep 2026
What types of coronary artery bifurcation lesions is the Tryton Side Branch Stent specifically designed to treat?
The Tryton Side Branch Stent is designed for de novo native coronary artery bifurcation lesions classified as Medina 1.1.1, 0.1.1, or 1.0.1. It targets side branches with a diameter stenosis of at least 50% and lesion lengths no longer than 5.0 mm, alongside specific reference vessel diameter ranges (2.5–3.5 mm in the side branch and 2.5–4.0 mm in the main branch). This ensures compatibility with balloon-expandable drug-eluting stents in the main vessel.
How is the Tryton Side Branch Stent deployed, and what makes its design unique compared to other stents?
The Tryton Side Branch Stent is deployed via a single-wire, balloon-expandable delivery system, which allows for precise placement in side branches. Its open architecture is a key feature, enabling it to accommodate conventional drug-eluting stents in the main vessel without obstruction, making it ideal for bifurcation lesions where both branches require intervention.
Is the Tryton Side Branch Stent intended for reuse, and if not, how should it be handled after use?
The Tryton Side Branch Stent is supplied sterile and explicitly intended for **single-use only**. After deployment, it should be discarded according to standard medical device disposal protocols to ensure patient safety and prevent cross-contamination.
What regulatory pathway was followed for FDA approval of the Tryton Side Branch Stent, and what does this mean for clinicians?
The Tryton Side Branch Stent received **FDA Premarket Approval (PMA P150039)**, which is the highest level of regulatory clearance for Class III devices. This means the device underwent rigorous clinical evaluation to demonstrate safety and effectiveness for its specified indications—treating de novo bifurcation lesions with the criteria outlined in the description. Clinicians can rely on this approval as evidence of its validated performance for the intended use.
What are the key size limitations for the side branch and main branch when using the Tryton Side Branch Stent?
The Tryton Side Branch Stent is designed for side branches with reference vessel diameters between **2.5 mm and 3.5 mm**, while the main branch should have diameters between **2.5 mm and 4.0 mm**. Additionally, the lesion length in the side branch must be **≤5.0 mm** with a diameter stenosis of ≥50%. These specifications ensure optimal deployment and compatibility with balloon-expandable drug-eluting stents in the main vessel.