Source: Heart Future; Editor: Sophia
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently，MitrAssist Lifesciences LimitedIndependently DevelopedChina's FirstTranscatheter Mitral Valve Replacement Products via Apical ApproachMitraFix® SystemOfResults of the First Phase of NMPA Registered Clinical TrialsOfficially published inJACC: Cardiovascular Interventions In the magazine.The study was conducted at four centers in China and enrolled a total of 10 patients who were unable to undergo traditional surgical treatment due to high surgical risk.These patients exhibited excellent clinical outcomes after being treated with the MitraFix system.。MitraFix® Transapical Mitral Valve System isThe World's FirstAchieve clinicallyThe entire process only requires full ultrasound guidance.The transcatheter mitral valve interventional replacement system,No contrast or radiation required during the procedure, completely radiation-free., The operation time is only twenty minutes,Doctors have a short learning curve and can be quickly promoted.。January 4, 2023, MitrAssist Lifesciences Transapical Mitral Valve SystemApproved by the National Medical Products Administration (NMPA)Application for Special Approval of Innovative Medical Devices("Green Channel")。 
The MitraFix system is uniquely designed to stabilize the anterior leaflet of the mitral valve and shorten the ventricular portion of the stent.Effectively avoids left ventricular outflow tract (LVOT) obstruction. In addition, the system alsoBuilt-in ultrasound markers, enhancing the precision during the surgical process and providing a higher level of safety assurance for high-risk patients.One-year follow-up results showed:• All patients were successfully implanted with the MitraFix valve,The success rate of the surgery has reached 100%.。• 90% of patients achieved complete elimination of mitral regurgitation after the surgery., the remaining patients' regurgitation decreased to mild (1+).• Two of the ten patients died, with one death attributed to cardiovascular causes.• 75% of surviving patients improved to NYHA functional class I or II.。• No complications such as left ventricular outflow tract obstruction (LVOT) or mitral stenosis were observed during the follow-up period.The quality of life of the patients has also been significantly improved, with a notable increase in the 6-minute walking distance compared to pre-operation., demonstrating the great potential of the MitraFix system in improving patients' cardiac function and quality of life.MitraFix consists of a transcatheter artificial mitral valve, delivery system, and loading tool.，It is the world's only transcatheter mitral valve replacement product that can be delivered via both transapical and transfemoral approaches.It delivers the artificial mitral valve to the mitral valve annulus position via a transapical or transfemoral delivery system.High implantation success rate, easy to operate and master; isOnly ultrasound-guidedA green, radiation-free surgery that can be completed immediately.The product has a unique valve frame design:Single-layer self-expanding valve frame，Double-row blunt anchor fixation mechanism, which can achieve firm fixation and ensure precise leaflet coaptation,High fault tolerance for implantation procedures; The small protrusion in the left ventricular outflow tract can anchor the anterior leaflet with an anchoring claw design, providing both fixation and sealing functions.Making the LVOT risk smaller and able to prevent the valve from moving forward during cardiac systole.(SAM phenomenon). Among similar products,Minimum outer diameter, which can minimize the damage to the myocardium to the greatest extent. Its unique strong echo direction marker and height marker,Can achieve valve implantation with ultrasound guidance only。MitraFix®The delivery system has two ultrasound markers embedded to indicate the direction of rotation and the depth of insertion, which can clearly show the relative positional relationship with the valve annulus in the ultrasound image.The entire release process does not require precise capture of the leaflets or subvalvular structures., thus allowing for a greater tolerance in operational and positioning accuracy. This is also the main reason why this product can complete the implantation process with only ultrasound image guidance.
Unlike interventional mitral valve repair, MitraFix®The transcatheter mitral valve replacement system is not limited by the anatomy of valve disease.Compatible with primary mitral regurgitation (DMR) and secondary mitral regurgitation (FMR), the implantation procedure is more straightforward, offering broad market application prospects and representing a research and development hotspot in the field of international interventional mitral valve devices.。# Mitral Regurgitation Market Size
The prevalence of moderate to severe mitral regurgitation globally was 1.25% in 2017, and it reached 1.28% in 2021. It is projected that...By 2027, the global prevalence of moderate to severe mitral regurgitation will further increase to 1.37%.。
The number of patients with moderate to severe mitral regurgitation worldwide increased from 93.5 million in 2017 to 99.9 million in 2021, with a compound annual growth rate of 1.7% from 2017 to 2021. This patient population is expected to continue expanding.It is expected to reach 114 million patients by 2027., with a projected compound annual growth rate of 2.2% from 2021 to 2027.
▲ SourceFromFrost & Sullivan
The global number of transcatheter mitral valve repair surgeries increased from 15,300 in 2017 to 27,700 in 2021, with a compound annual growth rate of 16.0% from 2017 to 2021. It is expected that...By 2027, the global volume of transcatheter mitral valve repair procedures will reach 104,300., with a compound annual growth rate of 24.7% from 2021 to 2027.
▲Source:Frost & Sullivan
In China, the prevalence of moderate to severe mitral regurgitation in the population aged 35 and above increased from 1.31% in 2017 to 1.37% in 2021.It is estimated that by 2027, the prevalence will increase to 1.42%.。
The number of patients with moderate to severe mitral regurgitation in China increased from 10 million in 2017 to 11.1 million in 2021, with a compound annual growth rate of 2.6% from 2017 to 2021. This patient population is expected to continue expanding.It is expected to reach 12.6 million people by 2027., with a compound annual growth rate of 2.1% from 2021 to 2027.
▲Source:Frost & Sullivan
In 2021, the number of transcatheter mitral valve repair surgeries in China was approximately 200.ExpectedWill reach 20,000 units by 2027, with a compound annual growth rate of 117.3% from 2021 to 2027。
▲SourceFrost & Sullivan
# MitrAssist LifesciencesMitrAssist Lifesciences was founded in 2017 as an innovative platform-based medical device enterprise in the cardiovascular field, with products involvingStructural Heart, Heart Failure, Coronary ArteryIn multiple significant fields, with a rich product line.Currently, it has research and development centers in China, Israel, and Germany, an independent sales team established in the United States, and a mature distributor system set up in multiple overseas countries.On July 6, 2022, MitrAssist Lifesciences independently developedWorld's First Polymer Valve Polymer TAVR Product SIKELIA™The world's first clinical implantation was successfully completed by the team of Academician Ge Junbo at Zhongshan Hospital, Fudan University in Shanghai, marking the entry of interventional treatment for valvular heart disease into a new polymer era. Currently, the product has completed the FIM clinical trial, with multiple patients having post-operative follow-ups exceeding one year, and the longest follow-up reaching 21 months, demonstrating its feasibility, safety, and effectiveness. The project also won the highest award, the "Outstanding Award," in the 2022 National Ministry of Science and Technology's Disruptive Technology Innovation Competition.MitraFix, the first transapical mitral valve interventional replacement product independently developed by MitrAssist Lifesciences in China.®Has entered the special review for innovative medical devices by the National Medical Products Administration (NMPA). This product is not only safe and reliable, but also easy to use and convenient to promote, with the entire surgery requiring only full ultrasound guidance.MitrAssist Lifesciences' Non-Invasive Heart Failure Management Device ReDS™Pro, Following Its Launch in the U.S., Europe, India, and Japan, Has Now Been Approved for Marketing in China.ReDS Device is Currently the World's Only Non-Invasive 5A Principle Heart Failure Management Device。Coronary Products"Paclitaxel-Coated Coronary Balloon Dilatation Catheter" — XunNiao®Has been approved for marketing in China, the first approved product in China to use 4th-generation paclitaxel drug-coating technology for its type.As of the date of this report, the company's financing history is as follows:
