TaurusOne® is a transcatheter aortic valve replacement system that includes a PAV, a DCS and a LS.
The PAV is manufactured by suturing three valve leaflets and a sealing skirt onto a self-expanding, radiopaque frame made of nickel-titanium alloy, which is designed to replace and serve the physiological function of the patient’s native aortic heart valve without the need for an open-heart surgery.
l Self-expanding, radiopaque frame made of nickel-titanium alloy
l Imported bovine pericardium leaflets with even thickness that have no delamination
l Low valve position on frame
Leaflets positioned low on the frame.
l Sealing skirt
The sealing skirt is made of polyethylene terephthalate and seamlessly attached to the frame.
The DCS includes an integral delivery catheter device used to deliver and release the PAV. It includes a tip, a sheath tube, a catheter and a handle.
l Sheath tube
The sheath tube has an outer diameter of 18Fr and is compatible with an 18Fr introducer sheath and a 0.035-inch guidewire.
The sheath tube is connected to a catheter that has an outer diameter of 14Fr and is designed with multiple sections.
Once the PAV reaches the target position, the physician can turn the DCS’ handle counterclockwise to deploy the PAV.
Clinical Trial Results
TaurusOne® has been recognized as an “innovative medical device” by the NMPA in February 2017, and is therefore eligible for an expedited approval process. The Company was approved by the NMPA to conduct a single-center feasibility clinical trial and a multi-center confirmatory clinical trial for TaurusOne®. According to Frost & Sullivan, among all the players in the TAVR product market in China, the Company is the only one that has conducted both feasibility and confirmatory clinical trials for the first generation TAVR product whose clinical trial protocols have been approved by the NMPA.
In August 2017, the Company completed a single-center feasibility clinical trial in China for TaurusOne® in accordance with the principles set forth in the “Principles for Clinical Trial Review for Transcatheter Aortic Valve Implantation” (the Draft TAVR Clinical Trial Principles) to principally evaluate the safety of TaurusOne®. Physicians at Beijing Fuwai Hospital conducted TAVR procedures on ten trial subjects using TaurusOne®. The primary safety endpoint was the all-cause mortality rate of the trial subjects within 30 days post interventional procedure. Throughout the follow-up period, among all the ten subjects, the Company observed nil all-cause mortality, nil stroke, one atrioventricular block, one cardiovascular surgical intervention during procedure, one permanent pacemaker implantation before discharge and one moderate paravalvular leak, and the subjects’ cardiac functions improved significantly after the procedures.
In September 2017, the Company started the multi-center confirmatory clinical trial in China for TaurusOne® to confirm its safety and efficacy. Physicians conducted TAVR procedures using TaurusOne® in six hospitals, with Beijing Fuwai Hospital as the principal investigator institution. The primary endpoint was the all-cause mortality rate of the trial subjects within 12 months post interventional procedure. In April 2020, the Company had completed the 30-day, six-month, and 12month follow-ups for all the trial subjects, and are in the process of conducting data analysis and preparing the clinical trial report. Throughout the 12-month follow-up period, the Company observed ten all-cause mortalities among the 125 trial participants. Among the 125 trial subjects, the procedural success rate was 97.6%. The all-cause mortality rate for the 125 subjects was 1.6% at 30 days, 3.2% at six months and 8.0% at 12 months.