A Medical Device Daily

Cardiovascular device manufacturer Cardima (Fremont, California) reported that it met June 10 with the FDA’s Center for Devices and Radiological Health to continue the process towards approval of its Revelation Tx ablation catheter for treatment of atrial fibrillation (AF).

The premarket approval application (PMA), previously submitted in June 2003 and amended in January 2004, includes Phase III data obtained by treating self-terminating AF. Trial data indicated, Cardima said, that substantial and statistically significant improvements were realized almost uniformly for all measured arrhythmia symptoms as well as for quality-of-life measures. The study demonstrated that the addition of right atrial catheter ablation to a regimen of previously ineffective antiarrhythmic drugs yields “a significant reduction in the frequency, duration and severity of AF episodes and symptoms.” Of the 93 subjects included in the trial, 90% provided six-month AF episode frequency data which demonstrated a significant decrease in symptomatic frequency when compared to baseline, the company said. And 58% were considered a clinical success by protocol definition.

Focus of the meeting with the FDA was to discuss the issues stated in the May 21, 2004, and the June 26, 2003, FDA non-approvable letters, Cardima said. While it said that “no conclusions were reached” at the meeting, there was an agreement “to continue the dialogue.” A date for a follow-up meeting was not set.

Cardima said it believes that the data submitted in January 2004 in an amended PMA for the Revelation Tx “provides sufficient support for safety and effectiveness to reduce symptomatic AF burden and improve the quality of life of patients suffering from self-terminating but very uncomfortable AF within the least burdensome guidelines of the FDA.”

Chairman and CEO Gabriel Vegh said, “We are encouraged by this opportunity to have an extended discussion on specific issues and remain optimistic about gaining the approval for the Revelation Tx.”

The non-approvable letter received by Cardima on May 28, 2004, informed the company that the FDA had determined that Cardima’s Revelation Tx Microcatheter with NavAblator Ablation System PMA was not approvable. The letter indicated that the FDA believed that collecting additional data using a revised study design would be the least burdensome approach to demonstrate device safety and effectiveness.