EPIX Therapeutics, a medical device company that designs and manufactures a catheter-based system for the treatment of patients with atrial fibrillation (AF), has announced achievement of the enrolment goal of the DIAMOND-AF study, a global FDA-approved IDE pivotal study to evaluate the DiamondTemp ablation system in patients with paroxysmal AF. The DIAMOND-AF study was scheduled to enrol a maximum of 480 subjects, randomised 1:1 between the DiamondTemp ablation system and a control device. The enrolment phase was completed in 11 months and will be used to support PMA approval of the DiamondTemp ablation system.
“We are pleased with the speed at which we were able to enrol the DIAMOND-AF study, an achievement that reflects the extremely positive response to the DiamondTemp system from our physician investigators,” says Duke Rohlen, EPIX chairman and CEO. “With enrolment in our pivotal trial complete, the DiamondTemp ablation system is poised to be the first irrigated, closed-loop temperature-controlled system with fast ablation on the market. We believe that this innovative new technology will ultimately enable better outcomes for patients with AF.”
EPIX also announced today the start of enrolment in the DIAMOND-AF II study, an FDA-approved IDE pivotal study to evaluate the DiamondTemp ablation system in patients with persistent AF. DIAMOND-AF II is a prospective, single-arm study and will enrol up to 300 subjects in the USA, Europe and Canada. Judson Colley of Jackson Heart Clinic in Jackson, Mississippi enrolled the first subject in the USA and Hervé Poty at the Clinique du Tonkin Hospital in Lyon, France enrolled the first European subject. Both Colley and Poty were investigators in the DIAMOND-AF study. Colley is also a steering committee member for the DIAMOND-AF II study.
“I appreciated the DiamondTemp system’s procedural speed and performance in the subjects that I enrolled in the DIAMOND-AF Study,” says Colley. “I continue to be impressed with the system now in the DIAMOND-AF II study; this technology has the potential to significantly advance our ability to treat patients with persistent atrial fibrillation. I find that awareness of tissue temperature during ablation adds a new level of control not previously seen in these procedures.”