Medtronic announces pivotal Cardioblate trial

Medtronic has announced the initiation of a pivotal clinical trial of the Cardioblate surgical ablation system in the US. The system is being tested as a treatment for the cause of permanent atrial fibrillation (AF).

Cardioblate is an irrigated radiofrequency surgical ablation system that can block irregular signals of the heart to normalise heart rhythm through the creation of lesions on heart muscle tissue.

The concomitant utilisation of radiofrequency energy for AF trial will evaluate the efficacy and safety of the system in patients with AF that require the Cox Maze III procedure in open heart surgery.

Dr Ralph Damiano, co-principal trial investigator, said: “Patients who have permanent AF are at significant risk for stroke and death when compared to patients in normal sinus rhythm.

“In addition, these patients can experience uncomfortable symptoms from their AF including heart palpitations, dizziness, fatigue and shortness of breath.”

He added that the condition can often lead to heart failure, while the ability to block AF could potentially lead to progress in improving the survival and quality of life of sufferers of the condition.

Earlier this week, Medtronic announced that it received approval from the US Food and Drug Administration for the marketing of its Infuse bone-graft treatment for oral maxillofacial and dental regenerative bone grafting.