The first US patient has been successfully treated with JC Medical’s transfemoral transcatheter aortic valve implantation (TAVI) device, the J-Valve TF system. The patient was treated at The Christ Hospital (Cincinnati, USA) by Dean Kereiakes, medical co-director of the Lindner Research Center, working with Joseph Choo and Geoffrey Answini.
The US 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 USA and over 18 million worldwide.
Aortic regurgitation is the primary indication for more than 20% of surgical heart valve replacements, but there are no transcatheter aortic valves that are approved in the USA or Europe to treat aortic regurgitation patients too sick to undergo open surgical repair.
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.
The world’s first J-Valve TF implant was performed earlier this year by John Webb and Jian Ye at St Paul’s Hospital in Vancouver, Canada. This case was recently published online ahead of print in EuroIntervention (20 November, 2018).
The company plans to initiate a US clinical trial of the J-Valve in 2019.