JC Medical said today that the company’s first U.S.-based patient was treated with its transfemoral transcatheter aortic valve implant system, J-Valve TF.
The FDA approved the use of J-Valve for people with aortic regurgitation through its “compassionate use” pathway. JC Medical also noted that it’s gearing up for a clinical trial of the investigational device in the U.S. this year.
The first U.S. patient to use JC Medical’s J-Valve TF system was treated at The Christ Hospital in Cincinnati, Ohio by Dr. Dean Kereiakes, who serves as the medical co-director of the Lindner Research Center.
“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,” Dr. Kereiakes said in prepared remarks. “J-Valve was clearly the best treatment option for our patient.”
“We are very pleased that our J-Valve could help this patient. We developed the J-Valve to be reliable and suitable for treating a broad range of heart valve diseases,” Dr. Ji Zhang, founder & chief technical officer at JC Medical, added. “We thank the physician group who has recognized this unique clinical solution. 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.”
JC Medical’s investigational system is designed to restore normal blood flow out of the heart and into the body for people suffering from heart failure. The device includes an anchor mechanism that is linked to a self-expanding stent frame, which attaches to the failing native heart valve. The J-Valve also doesn’t necessitate calcification of the native valve, JC Medical noted.
In May last year, doctors in Vancouver performed the first clinical procedure using JC Medical’s J-Valve TF implant.