Vytronus Nearly Finished Enrolling Patients in Clinical Trial of Automated Ultrasound AF Treatment

 Vytronus Inc., a privately held medical device company developing technologies for cardiac arrhythmia treatment, announced that its early feasibility study of automated ultrasound technology for the treatment of persistent atrial fibrillation has nearly completed enrollment.
 
Vytronus is developing the only treatment option for atrial fibrillation (AF) that uses low-intensity collimated ultrasound (LICU). Unlike other approaches for AF ablation, the LICU catheter inherently does not require contact with the tissue and is capable of both 3D anatomical mapping and ablation. Featuring a robotic catheter tip, the Vytronus LICU system can quickly and precisely generate high-resolution 3D anatomical images. Utilizing the same catheter, the system delivers precisely controlled ultrasound energy for therapy along a user-specified lesion path. 
 
Aiming to determine the feasibility of using the Vytronus LICU system to create continuous, durable, flexible lesions that emulate aspects of the Cox Maze procedure to treat persistent AF, the feasibility study has an enrollment target of up to 30 patients at two sites: Na Homolce Hospital (NHH) in Prague, Czech Republic; and Southlake Regional Health Centre in Newmarket, Canada.
 
The study’s primary endpoints include acute and chronic safety, as well as six- and 12-month chronic efficacy and reduction of AF burden. 
 
NHH enrolled the first 16 patients in this persistent AF feasibility study (PFS).
 
“We have amassed significant clinical experience with the Vytronus technology over the past three years,” said Petr Neužil, M.D., Ph.D., chairman of NHH’s cardiology department. “Our electrophysiology team has completed more than 70 ablation procedures using LICU in patients with paroxysmal AF and, most recently, 16 patients with persistent AF. We are very pleased with the platform’s continuously improving capabilities and find it highly efficacious in not only isolating all pulmonary veins but also the posterior wall of the left atrium to achieve a continuous box lesion. Just as importantly, the computer-assisted automation feature leads to reduced dependence on operator skill, excellent continuity of the designed lesions and a substantial reduction in x-ray exposure.”
 
Southlake will enroll the remaining PFS patients.
 
“This study will seek to determine the initial clinical performance of LICU in the treatment of persistent AF,” said Atul Verma, M.D., medical director of Southlake’s Heart Rhythm Program. “We are especially interested in evaluating the technology’s ability to consistently isolate the pulmonary veins and the left atrium’s posterior wall in this challenging patient population, without relying on the high level of operator skill required to make precise and durable point-by-point radio-frequency lesions.”
 
The VALUE study, the first clinical trial utilizing the Vytronus LICU system, enrolled 50 patients with paroxysmal atrial fibrillation. Presented at AF Symposium 2019 on Jan. 25 in Boston by Vivek Y. Reddy, M.D., director of cardiac arrhythmia services for the Mount Sinai hospital and health system in New York, N.Y., the results showed 80 percent freedom from symptomatic AF/AT/AFL¹ at 12 months.
 
“LICU enables the automated creation of 3D anatomic maps and free-form, continuous, and durable lesions while reducing dependence on operator skill,” explained John Pavlidis, president and CEO of Vytronus. “It is the only technology of its kind that can create versatile lesion patterns similar to point-by-point radio-frequency ablation with the precision of robotic-assisted automation.”
 
The Vytronus LICU system has been submitted for CE Mark as a treatment for paroxysmal AF and is not commercially available anywhere in the world. It is only approved for investigational use in Europe and is not approved for use in the United States.
 
With an estimated 5 million new cases per year worldwide, atrial fibrillation is a common condition in which the upper chambers of the heart beat rapidly in an uncontrolled manner. Also known as AF or AFib, it is classified in three categories: paroxysmal, persistent and long-standing persistent. An estimated 75 percent of patients with atrial fibrillation suffer from either the persistent or long-standing persistent form of the condition. 
 
Accredited by JCI (Joint Commission International), Na Homolce Hospital is one of the top hospitals in Europe and focuses on the treatment of cardiovascular and neurological/neurosurgical diseases. Within the cardiovascular specialization, NHH offers the largest range of modern and clinically verified diagnostics and treatments, including conservative treatment, minimally-invasive techniques and surgical procedures on the heart and blood vessels. Its cardiology centers include those for the treatment of cardiac rhythm disorders, chronic heart failure, congenital heart defects, aortic disease and valvular heart disease, as well as robotic cardiac and vascular surgery.
 
Southlake Regional Health Centre is a full-service hospital with a regional, clinically advanced focus, located in Newmarket, Ontario, Canada. Southlake offers 426 patient beds and accommodates more than 113,000 visits to the Emergency Department, 24,000 in-patient admissions and 530,000 out-patient visits each year. As a regionally designated site, Southlake is responsible for developing and providing advanced levels of care to the more than one million people. Advanced, specialty services include: arthritis care, cancer care, cardiac care, child and adolescent eating disorders and mental health services for children.
 
Headquartered in California’s Silicon Valley, Vytronus Inc. was formed in 2006 to harness the imaging and therapeutic capabilities of ultrasound energy to treat cardiac arrhythmias, starting with atrial fibrillation.

Reference
¹ AFL = atrial flutter  AT = atrial tachycardia  AF = atrial fibrillation