FDA approval and first use of MediGuide enabled ablation catheters announced


St Jude Medical announced on 15 August that the US Food and Drug Administration (FDA) has approved its MediGuide enabled ablation catheters.

The MediGuide enabled ablation catheters can be visualised using three dimensional magnetic tracking. The catheters are used to create lesions during cardiac ablation procedures to treat atrial flutter.

MediGuide sensors allow the catheters to be visualised and navigated in real time on pre-recorded fluoroscopy.

“The availability of MediGuide ablation catheter tools allows us to effectively treat patients with ablation therapy using minimal exposure to radiation,” said Chun Hwang, director Cardiac Electrophysiology, Utah Valley Regional Medical Center, Provo, USA, who performed the first procedure with the new ablation catheter. “We are exposed to radiation multiple times a day, which adds up quickly. Reducing the exposure time to radiation is a huge benefit for everyone in the electrophysiology lab.”

The Safire Duo and Cool Path Duo irrigated tip ablation catheters can now be visualised and navigated in real time on pre-recorded fluoroscopy with MediGuide technology. Featuring a high-performance tip with uni-directional or bi-directional deflection, these ablation catheters have the ability to be steered in two different directions for improved reach and manoeuvrability. They also include 12 irrigation ports for cooling tissue during procedures, it said in the press release.

“The new MediGuide enabled ablation catheters expand the utility of the MediGuide system, which is an important platform that provides clinicians with the ability to reduce the duration of radiation exposure and improve the accuracy and consistency of procedures”, said Frank J Callaghan, president of the St Jude Medical Cardiovascular and Ablation Technologies Division.