MK
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Percutaneous Transluminal Valvuloplasty (Canada)

Mitral Dilatation Kit

The Bonhoeffer Multi-Track Mitral Dilatation Kit was developed in collaboration with Dr. Philipp Bonhoeffer and is an innovative and well-established system for Mitral Dilatation.  This consists of a double balloon technique while using a simple, single guidewire approach.  The innovative approach was invented to solve the problem of the mismatch between the round shape of a single balloon and the oval mitral orifice.  The technique achieves consistently higher valve areas post dilatation.

Kit Components

The kit contains a Multi-Track balloon catheter, a matched rapid exchange balloon catheter, a Multi-Track™ angiographic catheter, a dilator and a super stiff guidewire.  

The catheter bodies are DEHP-free and not made with natural rubber latex. The balloons are a thermoplastic elastomer; non-compliant - which will not exceed +/- 10% of the labeled balloon size at RBP, are DEHP-free, and not made with natural rubber latex.

  • Mitral Kit Components include:

    • Multi-Track balloon dilatation catheter (14, 16, 18 or 20mm in diameter) x 5cm in length
    • Matched rapid exchange balloon dilatation catheter
    • 14 FR, 70cm dilator
    • Multi-Track™ angiographic catheter (5 FR x 80 cm)
    • Super stiff, 0.035” guidewire with floppy tip

    Indication:  Percutaneous transvenous mitral commissurotomy in patients with hemodynamically significant mitral valvular stenosis

    Mitral Dilatation Kit IFUs:

    CANADA: RM0425-18c
    INTERNATIONAL: RM0344-18i

    Post Market Clinical Follow-up Form (US and CA)

Disclaimer

All products are subject to individual country regulations in regards to the importation and/or sale of these products. Refer to Instructions for Use for a complete listing of indications, contraindications, warnings, and precautions.