New Global IDE Study is Evaluating the DiamondTemp™ Ablation System in Persistent Atrial Fibrillation
SANTA CLARA, California, Oct. 4, 2018 /PRNewswire/ -- EPIX Therapeutics, Inc., a medical device company that designs and manufactures a catheter-based system for the treatment of patients with atrial fibrillation (AFIB), today announced achievement of the enrollment goal of the DIAMOND-AF study, a global FDA-approved IDE pivotal study to evaluate the DiamondTemp Ablation System in patients with paroxysmal AFIB. The DIAMOND-AF study was scheduled to enroll a maximum of 480 subjects, randomized 1:1 between the DiamondTemp ablation system and a control device. The enrollment 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 enroll 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 enrollment 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 AFIB."
EPIX also announced today the start of enrollment in the DIAMOND-AF II study, an FDA-approved IDE pivotal study to evaluate the DiamondTemp Ablation System in patients with persistent AFIB. DIAMOND-AF II is a prospective, single-arm study and will enroll up to 300 subjects in the United States, Europe and Canada. Dr. Judson Colley of Jackson Heart Clinic in Jackson, Mississippi enrolled the first subject in the United States and Dr. Hervé Poty at the Clinique du Tonkin Hospital in Lyon, France enrolled the first European subject. Both Drs. Colley and Poty were investigators in the DIAMOND-AF study. Dr. Colley is 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 Dr. 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."
About Atrial Fibrillation Atrial fibrillation is a condition in which the heart beats irregularly due to improper electrical impulses and is one of the most prevalent heart diseases globally, currently affecting an estimated six million people in the U.S. alone. The irregular heart beat can lead to increased risk of stroke and significant diminishment of quality of life for affected individuals. Catheter ablation has been demonstrated to be a safe, effective and economic treatment for atrial fibrillation. The catheter ablation market is one of the fastest growing medical device markets today.
About EPIX Therapeutics, Inc. EPIX Therapeutics, Inc. is a medical device company that designs and manufactures a catheter-based system for the treatment of patients with AFIB. The Company's mission is to dramatically improve the treatment of AFIB through the introduction of products based on its proprietary catheter and generator system. EPIX's technology is the only system in the world to leverage three unique capabilities: temperature sensing and feedback, low irrigation flow rates and high resolution electrogram attenuation. The DiamondTemp Ablation System is CE Marked and limited to investigational use in the United States.