Indication

The SafeCross™ Transseptal RF Puncture and Steerable Balloon Introducer System is used for introducing various cardiovascular catheters into the heart, including the left side of the heart. The system enables left heart access through a puncture of the atrial septum during a transseptal catheterization procedure. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.

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The SafeCross™ Transseptal System is for use only by trained physicians in strict accordance with the FDA cleared Instructions for Use. The SafeCross System is commercially available for clinical use or sale only in the United States. SafeCross is a registered trademark, in the US and internationally for East End Medical I, LLC.

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