Device Dossier

Heartspan Fixed Curve Braided Transseptal Sheath - Transseptal access system

Device Dossier for Heartspan Fixed Curve Braided Transseptal Sheath - Transseptal access system (Transseptal access system, Class III, sponsor Merit…

Intended purpose

For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal puncture.

Functional description

The braided transseptal sheath is designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations in addition to providing support for positioning and maintaining the position of catheters at specific locations within the heart. The kit consists of a sheath, a dilator, and a J-tipped guidewire. The sheath has a radiopaque marker band, an atraumatic soft tip, and a lubricious coating. The dilator has a tapered tip.

TGA Public Summary