Inoue Balloon Catheter

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

CATHETER, PERCUTANEOUS (VALVULOPLASTY)

PMA Number

P910054 ↗

FDA Product Code

MAD

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

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See all devices from Toray Industries (America), Inc. →

• What is the Inoue Balloon Catheter specifically used for in clinical practice?

  The Inoue Balloon Catheter is designed for **percutaneous transvenous mitral commissurotomy**, a procedure to mechanically widen a narrowed (stenotic) mitral valve. It works by inflating a balloon within the valve to separate fused leaflets, thereby improving blood flow between the left atrium and left ventricle. This is typically performed in patients with mitral valve stenosis where surgical intervention is not feasible.

• How is the Inoue Balloon Catheter supplied, and is it reusable?

  The device is supplied **sterile** and is explicitly intended for **single-use only**. Due to its specialized design and regulatory classification as a Class III device, reuse is not recommended or supported by the manufacturer, ensuring patient safety and procedural efficacy.

• Are there different sizes or models available for the Inoue Balloon Catheter, and how are they determined?

  The Inoue Balloon Catheter comes in **specific sizes and configurations**, as detailed in the PMA (P910054). The appropriate size is selected based on the patient’s anatomy and the severity of mitral valve stenosis, ensuring optimal dilation of the valve leaflets. The manufacturer’s documentation references these variations, and the procedure must be performed by trained professionals familiar with sizing guidelines.

• What storage requirements should be followed for the Inoue Balloon Catheter before use?

  Since the device is **sterile** and single-use, it should be stored in its original packaging in a **clean, dry environment** away from direct sunlight or extreme temperatures. The packaging must remain intact until immediately before use to maintain sterility and functionality. Always check the expiration date and follow manufacturer instructions for storage conditions.

• What regulatory pathway does the Inoue Balloon Catheter follow, and how does this affect its use?

  The Inoue Balloon Catheter requires a **Premarket Approval (PMA)** under FDA regulations, specifically PMA number **P910054**, due to its classification as a Class III device. This means it undergoes rigorous review by the FDA’s Cardiovascular (CV) advisory committee before approval. Clinicians must ensure the device is used in compliance with the approved indications and procedures outlined in the PMA documentation, typically in controlled clinical settings by trained specialists.