Announces FDA Approval to Begin Enrolling Persistent Atrial Fibrillation Subjects in Global IDE Study to Evaluate the DiamondTemp™ Ablation System
SANTA CLARA, California, Aug. 13, 2018 /PRNewswire/ -- Advanced Cardiac Therapeutics, Inc. (ACT), a medical device company that designs and manufactures a catheter-based system for the treatment of patients with atrial fibrillation (AFIB), today announced it has changed its name to EPIX Therapeutics, Inc.
Founded in 2007, the company has pioneered the development of catheter ablation solutions for the treatment of atrial fibrillation and other arrhythmias. In 2014, the company brought in industry veteran Duke Rohlen as Chairman and CEO. Rohlen built a team that developed a novel technology, the DiamondTempTM radiofrequency ablation system, designed to treat patients with AFIB. In late 2017, the DiamondTempTM system received CE Marking for the device, and FDA approval of an investigational device evaluation application (IDE) to commence a 480-subject, multicenter, global, pivotal trial (Diamond-AF) to treat patients with paroxysmal AFIB. The company expects to complete the enrollment of this IDE study the end of 2018.
"We are excited by the significant progress we have made with the company over the last 4 years," said Rohlen. "The DiamondTempTM radiofrequency ablation system has proven to be extremely fast and reliable and, we believe, has the ability to re-define the industry landscape. Our goal is to be the go-to ablation tool used by electrophysiologists in treating all forms of AFIB by combining a safe and reliable catheter system with industry-leading efficacy, procedural speed and ease of use."
EPIX also announced today that is has received IDE approval from the FDA for the Diamond-AF II pivotal trial to study the DiamondTempTM technology in patients with persistent AFIB, a more severe form of the condition. The trial is projected to enroll up to 300 subjects in the United States, Canada and Europe and will begin enrolling in the fall of 2018.
Dr. Atul Verma, Global Principal Investigator for the Diamond-AF II study, says, "I am thrilled to partner with EPIX Therapeutics to design a study and expand the technological landscape for the treatment of persistent AF in patients who are unable to control their abnormal heart rhythm with antiarrhythmic drugs or tolerate their side effects." Dr. Verma is a cardiac electrophysiologist at the Southlake Regional Health Centre in Toronto, Canada.
Dr. Andrea Natale, the United States Principal Investigator for the Diamond-AF II study, says, "We are now looking forward to evaluating the Diamond-AF investigational device in patients with persistent AFIB and commencing the FDA IDE study in the United States." Dr. Natale serves as the executive medical director at the Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin, Texas.
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. (formerly ACT)
EPIX Therapeutics, Inc. (formerly Advanced Cardiac 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 DiamondTempTM System is limited to investigational use in the United States.