JC Medical announced the successful treatment of the first U.S. patient with the company’s transfemoral TAVR device, the J-Valve TF System. The patient was treated at The Christ Hospital – Cincinnati, Ohio. The U.S. Food and Drug Administration (FDA) approved the use of the J-Valve for patients with aortic regurgitation through the agency’s expanded access (“compassionate use”) regulatory pathway.
The investigational J-Valve TF system is intended as a new catheter-based option for the treatment of patients who suffer from aortic regurgitation. Failing aortic valves make up a significant portion of patients with heart failure, a major public health problem with a prevalence of over 1.5 million in the U.S. and over 18 million worldwide. Aortic regurgitation is the primary indication for more than 20 percent of surgical heart valve replacements, but there are no transcatheter aortic valves that are approved in the U.S. or Europe to treat aortic regurgitation patients too sick to undergo open surgical repair.
“The J-Valve TF system has specific attributes that differentiate it from all other currently available TAVR systems, which I believe will enhance the safety and efficacy of TAVR for the indications of aortic valvular insufficiency (regurgitation) and possibly valve-in valve replacement of failing surgically implanted bioprosthetic valves,” said Dr. Kereiakes.
JC Medical’s J-Valve System is designed to restore normal blood flow out of the heart and into the body, which may improve symptoms of heart failure such as shortness of breath, fatigue and chest pain. The J-Valve features a proprietary anchor mechanism that is flexibly linked to a self-expanding stent frame to uniquely attach to the failing native heart valve. The J-Valve does not require calcification of the native valve for fixation.
“We developed the J-Valve to be reliable and suitable for treating a broad range of heart valve diseases,” said Ji Zhang, M.D., founder and Chief Technical Officer of JC Medical. “Heart failure due to a defective aortic valve leads to a significant decrease in the quality of life, the loss of life for many, and costs the healthcare system billions of dollars annually. We look forward to further exploring the promise of J-Valve and its role in treating failing aortic heart valves.”
The company plans to initiate a U.S. clinical trial of the J-Valve in 2019