Cardima gets FDA clearance to sell new surgical ablation system

By Elaine Rigoli

Tampa, Fla., May 25 - Cardima, Inc. said the Food and Drug Administration has granted 510(k) marketing clearance for the new Cardima Ablation System, which ablates cardiac tissue during heart surgery using radio-frequency energy.

This system is expected to be used primarily by surgeons performing cardiac surgery using standard hospital laparoscopic as well as thorascopic techniques.

The Cardima Ablation System uses three components: commercially available surgical radio frequency generators; the new Cardima Surgical Ablation Probe with a linear array of multi-electrodes and adjacent thermocouples using the core technology similar to the company's Revelation series ablation micro-catheters; and an energy-management device called the Intellitemp, which uses a temperature feedback feature to apply radio-frequency energy to single or multiple electrodes on the probe simultaneously, the company said in a news release.

Fremont, Calif.-based Cardima develops a variety of micro-catheters designed for the diagnosis and treatment of cardiac arrhythmias.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.