First United States Procedure Performed With JC Medical's J-Valve TF System
January 7, 2019—JC Medical announced the successful treatment of the first United States patient with the J-Valve TF (transfemoral) system, the company’s transfemoral transcatheter aortic valve replacement (TAVR) device. The patient was treated by Dean Kereiakes, MD, with Joseph Choo, MD, and Geoffrey Answini, MD, at The Christ Hospital in Cincinnati, Ohio.
The investigational J-Valve TF system is intended for the treatment of patients with aortic regurgitation. The FDA approved the use of the J-Valve for patients with aortic regurgitation through the agency’s expanded access (compassionate use) regulatory pathway. The company plans to initiate a United States clinical trial of the J-Valve in 2019.
In the company's announcement, Dr. Kereiakes commented, “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. J-Valve was clearly the best treatment option for our patient.”
JC Medical advised that the J-Valve TF system is currently under clinical development and is for investigational use only. In April 2017, the J-Valve transapical system received approval in China, where it is commercially available.
The first J-Valve TF implant was performed in 2018 by John Webb, MD, and Jian Ye, MD at St. Paul’s Hospital in Vancouver, British Columbia, whose report of the case was published online ahead of print in EuroIntervention.