Koka Life Sciences' Self-Expanding Transcatheter Aortic Valve System Enters China's Innovative Medical Device Review Pathway

The company has developed a number of cardiovascular interventional products with independent intellectual property rights, among whichFirst Interventional Product——Mitral Valve Repair System LIFECLIPAs of July 2021Entering the formal registration clinical trial phase, and has demonstrated good safety and efficacy in preliminary clinical applications.

In addition, the company also focused on buildingTransfemoral Mitral Valve Repair System KokaClip and Transfemoral Replacement Valve KokaValve, these products all have unique technical advantages and characteristics,Has passed ethical review and is about to enter the clinical stage.。

• World's FirstThe 3D bending systemDemonstrates excellent operational stability, capable of precisely delivering the valve to the designated position;
• Unique 3 Controllable Positioning Components, significantly reducing coronary risk and precisely adapting to the anatomical structures of different patients;
• High Molecular Skirt Edge, effectively reducing paravalvular leakage;
• Micro-barb Design, which can prevent valve displacement and significantly reduce the stent diameter oversizing rate.

Professor Guo YingqiangFrom a clinical perspective, the current products for aortic regurgitationThe core challenge lies in the complete coaxiality of the valve, the rotatability and maneuverability of the anchoring system.Kokai Life Sciences' PIONEER TAVR Aortic Regurgitation System3D Spatial Adjustment Bending is a World-First Innovation, creatively solved the coaxiality problem of treating pure aortic regurgitation via the femoral artery. The valve positioning device is retrievable, and the anchoring device can rotate independently.Significantly Enhance Surgical Safety, and the valve implantation position is precise and controllable,Significantly Reduces the Risk of Pacemaker Implantation for Patients。

# FIM Clinical Trial

FIM First Case Enrollment：

On January 18, 2023, the West China Minimally Invasive Valve Team led by Professor Guo Yingqiang from West China Hospital of Sichuan University successfully applied the Kokai Life Sciences PIONEER TAVR Aortic Regurgitation System.Transfemoral Aortic Valve Replacement Performed on a High-Risk Surgical Patient with Severe Aortic Regurgitation. This surgery utilized the PIONEER TAVR Aortic Regurgitation System.First Patient Enrolled in FIM Clinical Trial，Catheter operation only takes 15 minutes, The surgery was very successful.

Postoperative Group Photo of Professor Guo Yingqiang's Team from West China Hospital, Sichuan University

Patient Details：

Female, 81 years old, presented with dizziness, chest tightness, shortness of breath, visual blackout, headache, nausea, and vomiting after activity without obvious cause more than 3 years ago; echocardiography suggestedAortic regurgitation (severe), mitral regurgitation (mild to moderate), left ventricular systolic dysfunctionSTS score 18.809%.

Preoperative CT showed:The patient's aortic valve is tricuspid, with a slightly enlarged non-coronary sinus. The valve leaflets show no significant thickening or calcification. The perimeter of the patient's aortic valve annulus is 85.1mm, equivalent to a diameter of approximately 27.1mm, and the left iliac artery is slightly tortuous.

Surgical Procedure：

After multidisciplinary discussion, Professor Guo YingqiangDecision to implant 29mm PIONEER TAVR valve。

A 29mm PIONEER TAVR valve was successfully implanted in the patient during the surgery.No reflux and paravalvular leakage after surgery. The patient's preoperative aortic pressure was 109/32 mmHg, and the postoperative aortic pressure was 108/63 mmHg.

Postoperative DSA angiography and TEE ultrasound of the patient showedThe interventional aortic valve is in good position, with no paravalvular leakage.Postoperative monitoring,Normal heart rate and ECG, no conduction block。

Good postoperative effect

Complete FIM Study：

FIM Study Completed by Valve Team Led by Professor Guo Yingqiang from Huaxi Hospital，All 10 patients included successfully completed the surgery., without transfer to surgery or death,30-day follow-up shows stable valve hemodynamics, low transvalvular pressure gradient, no residual AR, and significant clinical outcomes.. This technological breakthrough has been published in the internationally authoritative cardiovascular journal, the "Journal of the American College of Cardiology" (JACC).

FIM study results demonstrate that this novel TAVR system'sImplantation is feasible and safe.，Significant Short-term Results. This study enrolled 10 patients (40.0% male, mean age 72.5±1.6 years, mean STS score 9.7%±1.4%).100% Pure Severe AR), using the PIONEER TAVR Aortic Regurgitation System (respectively25#, 29#, and 31# with 2 cases each, 27# with 4 cases），Average operation time 42.0±3.0 minutes, with an average contrast agent dose of 127±7.0 mL.

Based on preoperative CT evaluation of the annulus diameter, the average oversize rate was 6.0% ± 1.1%. The average length of stay in the intensive care unit was 1.3 ± 0.2 days, and the hospital stay was 8.8 ± 1.3 days. Ultrasound follow-up at 30 days postoperatively showed,The mean transvalvular pressure gradient of the 10 patients was 10.5 ± 0.9 mm Hg, and only one patient had mild paravalvular leakage (PVL).。

# AboutKokai Life Sciences

Kokai (Nantong) Life Sciences Co., Ltd. was established in September 2018 and is aFocus on the field of structural heart diseaseA high-end biopharmaceutical technology enterprise integrating the research and development, production, and sales of medical devices，Development forValvular Diseases in Different Populations, with Different Needs, in Different ScenariosSystem solution.