CardioFuture at TCT 2025: Global Innovations in Cardiovascular Therapies and Chinese Breakthroughs
Medtronic
Medical Device Manufacturer
ReCor Medical
Developer of Renal Denervation Devices
Heart Future
Recently,The 37th Annual Scientific Session of the American Transcatheter Cardiovascular Therapeutics Conference（TCT 2025`)` was successfully held in San Francisco, USA.
AsThe "Barometer" of the Global Cardiovascular Intervention Field, This conference, hosted by the Cardiovascular Research Foundation (CRF), has attracted top global medical technology companies, clinical experts, and researchers to participate. It released 28 Late-Breaking Clinical Trials (LBCT) and several significant clinical research findings, coveringCoronary Intervention, Structural Heart Disease, Hypertension TreatmentCore tracks such as these. Chinese companies and research teams have made a brilliant appearance with original devices and clinical data, injecting Chinese momentum into the global cardiovascular treatment landscape.
# Core Progress of the Conference: Clinical Evidence and Technological Innovation Lead Treatment Transformation
(1) Hypertension Treatment:RDN Long-term verification of technical durability and safety
MedtronicSymplicity Spyral RDN System
▲Symplicity Spyral Renal Denervation Catheter Expands and Ablates Vessel Wall Nerves Within the Renal Artery
PublicationSPYRAL HTN-ON MED Test3 Annual follow-up data andSPYRAL AFFIRM Study First Results of High-Risk Cohort.
This system releases radiofrequency energy to the nerves around the renal artery during minimally invasive surgery, blocking the rise in blood pressure caused by excessive nerve excitement, and has been globally...80 Approved for marketing in multiple countries,2023 Year11 Monthly AcquisitionFDA Approval.3 Annual follow-up shows,RDN Group24 The reduction in hourly dynamic systolic blood pressure and office systolic blood pressure was significantly better than that in the sham operation group, renal artery stenosis.> 70% The proportion is0；SPYRAL AFFIRM The study confirmed that6 Significant blood pressure reduction, safety, and no increase in the use of antihypertensive drugs within months.
Recor Medical Paradise uRDN Platform
▲ParadiseWorking Principle of Renal Denervation Catheter System
As the world's first to receiveFDA ApprovedRDN Equipment, which utilizes high-frequency focused ultrasound for directional ablation of sympathetic nerves around the renal artery, has been successfully developed.CE Certification.
This conference announced globallyGPS Registration Research Data andRADIANCE Global clinical trial summary analysis confirms its sustained blood pressure-lowering effect, whileRDN Therapy Successfully Included in the U.S. Medicare System.
(II) Structural Heart Disease: Breakthroughs in Valve Treatment and Cardiac Pump Technology
EdwardSapien Cardiac Valve System
▲Sapien 3 Ultra ResiliaTranscatheter Aortic Valve Replacement System
PARTNER 3 Test7 Year follow-up data confirmed thatTAVR The system brings early and sustained treatment benefits to patients, with excellent long-term valve performance and durability.PARTNER 2 Intermediate-Risk Patient Study10 The annual results show that the valve maintains durable performance across patients of different risk levels and across generations of products.
In addition, it was also announcedENCIRCLE Single-Arm Pivotal Trial1 Annual Data andEVOQUE STS/ACC TVT Registration Study30 Follow-up results after several days.
AbbottTendyne TMVR System
For severe mitral annulus calcification (MAC) causing mitral valve dysfunction, providing a minimally invasive alternative treatment for patients at high risk for open-heart surgery.
SUMMIT-MAC Key trial (the first prospective multicenter trial adjudicated by a core laboratory) showed,12 Months without all-cause mortality and heart failure hospitalization rate60.4%，30 Timing100% The degree of mitral regurgitation in the patient has decreased.
Johnson & Johnson Heart PumpImpella CP Highly Recommended in Guidelines
Johnson & Johnson MedicalAbiomed BusinessImpella CP The system, as the world's smallest heart pump, temporarily takes over the pumping function by being implanted in the heart, providing the heart with an opportunity to rest and recover.
DanGer Shock Research10 The annual follow-up data showed that, compared with standard treatment, the absolute mortality rate was reduced.16.3%, the average survival period of patients was extended by approximately600 Day. Based on this evidence, the United StatesACC/AHA The latest guidelines from multiple societies have been elevated.Impella Recommended Level of Treatment: Treatment Options for Patients with Cardiogenic Shock
(III) Coronary Intervention:DCB Technology and Calcified Lesion Treatment Gain New Evidence
Boston ScientificAgent Drug-Coated Balloon (DCB）
2024 Year3 Monthly AcquisitionFDA Approved, this conference announces two sets of real-world research data.
First, relying onCathPCI Registration System,2024 Year4 Month to2025 Year6 Monthly Enrollment Exceeds12000 An observational, prospective, multicenter registry study of example patients;
Second, JapanALLIANCE Registration Study, Evaluation1800 Example: Patient used aloneDCB or "Drug-Eluting Stent+ DCB" Mixed Strategy inPCI Safety and Effectiveness in Treatment.
FastWave HealthcareSola LaserIVL System
▲FastWave MedicalMarketing Animation Screenshot, Showcasing ItsSolaSingle-Emitter Design of Coronary Artery Laser Intravascular Lithotripsy System
Using a streamlined anti-rupture balloon catheter, circumferential acoustic pressure waves are generated through a customized laser energy source to precisely address cardiovascular calcified lesions.
First-in-human study shows that the previous9 Example of Patient Stent Delivery Success Rate100%, the average diameter stenosis from pre-operation57.1% Postoperative Reduction8.6%，30 Main adverse cardiac events (MACE) The incidence rate meets safety expectations.
Comparison of Calcified Lesion Preprocessing Techniques: Two Randomized Controlled Trials Show That Traditional Techniques andIVL The efficacy is equivalent.Short-Cut Test (413 Example patient) confirmed that the cutting balloon withIVL In terms of the minimum stent area post-operation, degree of stent expansion, procedural success rate, and30 DayMACCE Incidence rate (all2.9%) with no significant difference, andIVL High cost of group surgery3632 USD;VICTORY Test (282 Example patient) shows that ultra-high pressure balloons withIVL The stent expansion rate reaches non-inferiority, with acute procedural success and strategic success rates being similar, and no significant difference in safety.
(IV)Pulsed Electric Field Ablation：Pulse BiosciencesClinicalThe first patient enrolled in the trial
In the field of atrial fibrillation ablation, pulsed field ablation (PFA) The competition in technology has entered a white-hot stage.
Following Medtronic and Boston Scientific,Pulse BiosciencesAt this sessionTCTAnnouncing itsNANOCLAMP AFThe trial has completed the enrollment of its first patient, bringing new possibilities to surgical atrial fibrillation ablation with its differentiated "nano-clamp" technology.
CellFXNanosecond Pulsed Field Ablation (nsPFA) The core of the system lies in applying electrical pulses with extremely high voltage and nanosecond-level width to the cell membrane. The resulting electric field effect can selectively create nanoscale irreversible electroporation on the cell membrane, leading to apoptosis or elimination of target cells (such as lesion cells), while maximizing the protection of surrounding non-cellular structures like blood vessels and nerves.
Unique Clamp Ablation Design: The system utilizes nano-clamp electrodes, enabling continuous linear transmural ablation during concurrent cardiac surgeries. Particularly effective for pulmonary vein leakage points that are difficult to address with traditional ablation methods, it achieves results through mechanical clamping.+The dual action of pulsed electric fields ensures ablation integrity, addressing the key clinical pain point of recurrence.
Non-thermal Ablation is Safer: Based on Nanosecond Pulsed Electric Field (nsPFA) technology, the ablation process does not generate high temperatures, which can avoid serious complications such as esophageal injury and phrenic nerve paralysis. Its safety has been confirmed throughFDA Initial Validation of Breakthrough Device Designation.
International Trial Layout: The first surgery completed at St. Helena Hospital in California, with plans to cover multiple countries and centers, including2An overseas site in the United States aimed at verifying the effectiveness of technology across different populations.
（Five) Other Core Areas: Non-implantablePCI Breakthrough in Pulmonary Embolism Treatment
No ImplantPCI Strategy Validation
SELUTION DeNovo Research1 The annual results showed that sirolimusDCB + Target vessel failure rate of the provisional stenting strategy (5.3%) Non-inferior to conventionalDES Strategy (4.4%), and80% The lesion does not require stent implantation.DCB Using micro-reservoir controlled release technology, it can maintain90 Effective drug concentration in days.
Advantages of Mechanical Thrombectomy for Pulmonary Embolism Become Prominent
Penumbra 16Fr Lightning Flash SystematicSTORM-PE The experiment showed that computer-assisted vacuum thrombectomy (CAVT`) Combined anticoagulation therapy,`48 HoursRV/LV The ratio decreased on average.0.52, relatively reduced29.7%, The positive treatment response rate reached78.3%, significantly better than anticoagulation therapy alone (respectively0.24、13.1%、51.9%), Technical Success Rate100%`, Median thrombectomy time`25 Minute.
（Six) New Highlights of the Meeting:AI Integration and Acute Intervention Session
This conference launched for the first time“TCT AI Laboratory", byCRF WithJon DeHaan Jointly created by the foundation, providingAI Immersive Course in Cardiovascular Diagnosis and Treatment, CoveringECG Analysis, diagnosis of coronary artery disease, etc., promoteAI Clinical Implementation of Tools; Meanwhile, an "Acute Intervention" Special Session is Set Up, Focusing on Emergency MedicinePCI, Valve/ Peripheral Interventional Emergency Techniques and Innovative Devices: Emphasizing Rapid Response and Improved Patient Outcomes.
# China Power: Original Devices and Clinical Research Debut on International Stage
Chinese Enterprises and Research Teams at This Year'sTCT2025 Achieve comprehensive breakthroughs.
Heart Future This Time Introduced This7Local Innovative Enterprises in China (CoreLink Medical, United Imaging Healthcare, Huihe Medical, MicroPort CardioFlow, Weiguang Medical, Dejin Medical, Qiwei Medical) with original devices and significant clinical data making a concentrated appearance, covering core tracks such as coronary intervention, structural heart disease, imaging technology, and mechanical circulatory support, comprehensively showcasing China's self-research and development strength and international level in the cardiovascular medical device field from technological innovation to clinical validation.
(1) Coronary Intervention Field: Breakthroughs in Bioresorbable Stents and Precision Treatment Technologies
Core Medical Technology
▲IBS® IIPeriod&IIITwo-Year Clinical Research PhaseTLFPost Hoc Analysis
Self-developedIBS® The Absorbable Drug-Eluting Coronary Stent System (World's First Fully Degradable Iron-Based Absorbable Stent) Becomes the Focus of the Conference, with Three Core Research Achievements Featured in the Core Special Session.
II Phase Clinical Study (IRONMAN-II): Prospective, multicenter, single-blind randomized controlled trial, in China36 Home-based Enrollment518 Subject,1:1 Compared with mainstream drug-eluting metal stents. Two-year follow-up shows clinical success rate in the test group.99.6%(Control Group98.8%), Late lumen loss within the diseased segment0.28±0.52mm`, not inferior to the control group (`0.23±0.43mm), and no stent thrombosis events occurred; complex lesions in the trial group (B2/C Lesion) Proportion71.6%, higher than the control group63.4%, applicable lesion length ≤33mm(Longest Stent38mm), Reference Vessel Diameter2.5-4.0mm(Minimum implantable blood vessel1.84mm), with a wider range of applications.
III Phase Clinical Study (IRONMAN-III): A prospective, multicenter, single-group objective performance criterion trial, enrolling1060 Number of patients, follow-up rate99%. Two-year follow-up target lesion failure rate (TLF）5.5%, with permanent drug-eluting metal stents (3.0%-11.9%) and other absorbable stents (1.7%-11.2%) Equivalent; the incidence of thrombotic events is only0.5%, Proportion of complex lesions74.9%，33mm/38mm Long Stent Utilization Rate24.4%`, Minimum Implantable Vessel Diameter`1.39mm, further verifying its safety and effectiveness in complex scenarios.
Technological Innovation: Stent Strut Thickness55-65μm(Thinner than mainstream permanent stents), strong radial support, animal experiments show7 Endothelialization Rate within Days80%(Far surpassing similar products30%), andMRI Compatible, operable without special screening, expected to fully replace permanent stents. Relevant data has been submitted.NMPA With the EUCE Registration Approval.
Qivimed
World's FirstArterfusion™ Infusion Catheter (World's Thinnest Infusion Microcatheter) Debuts on International Stage as Professor Mao Yi from Fuwai Hospital, National Center for Cardiovascular Diseases, Announces Clinical Research Findings.
The Product2025 Year9 Monthly AcquisitionNMPA Approval, available48 Safe placement in the body for hours, with intravascular positioning and placement achieved through pre-shaped design, sheathless placement, uniform intra-arterial drug delivery, and significantly improved drug diffusion efficiency.
The study confirmed that it continuously pumps in a low dose through intracoronary indwelling.IIb/IIIa Receptor antagonist, which can locally prevent platelet aggregation to avoid stent thrombosis without causing systemic coagulation disorders, providing a bridging treatment option for patients at high risk of severe bleeding, and is expected to expand in the future.STEMI Thrombolysis,HAIC And other fields.
(II) Structural Heart Disease Field: Valve Repair/ Replacement Instruments Become Core Highlights
Huihe Medical
The First Approved and Fully Self-Developed in ChinaK-Clip® Transcatheter Tricuspid Annuloplasty System, Announces World's First Randomized Controlled Trial of an Interventional Valve ProductTriStar-RCT) One-year follow-up results.
The study included109 Example of Symptomatic Severe Tricuspid Regurgitation (TR≥4+) Patient,55 Example included in the experimental group,54 Example included in the drug control group. One-year follow-up showed: experimental group84% PatientTR≤2+，96% PatientTR Reduce1 + Above,86% PatientTR Reduce2 + Above;NYHA III-IV Percentage of grade patients from baseline72.72% Decrease to9.26%，80% The patient's cardiac function has improved at least.1 Level; Quality of Life (KCCQ Score) significantly improved, and the heart failure readmission rate was significantly lower than that of the control group, fully verifying its effectiveness and superiority. The product adopts18Fr The sheath tube enters through vascular puncture, with operations and reversible steps on the atrial surface, a short learning curve, and no damage to the native valve leaflets, advancing China's transcatheter tricuspid valve treatment to an internationally advanced level.
Dejin Medical
InDragonFly Dual System (Mitral Valve+ Tricuspid Valve) Achieves Dual-Track Breakthrough, Academician Wang Jian'an's Team Delivers Special Lecture, Drawing International Attention.
DragonFly-M Mitral Valve Repair System: For Mitral Regurgitation (MR), using "free-angle locking+ "Central Occlusion Network" Design,120 Example: Key Study on Chinese Patients3 Annual follow-up data shows,82.5% TheDMR Patients achieve "no mortality, no mitral valve re-intervention,MR≤2+Composite Endpoint; All-Cause Mortality9.2%, Cardiac-related mortality7.6%, Stroke Incidence5.0%, without severe adverse events such as device-related embolism, and its safety is superior to some internationally similar products.
DragonFly-T Tricuspid Valve Repair System: The second-generation product features a dual-curved guiding sheath design, compatible with complex anatomical structures.52 Example feasibility study shows the success rate of device implantation96.2%, Success Rate of Surgery84.6%; Average Instrument Operation Time102.0±40.4 Minutes, Total Operation Time118.8±41.6 Minutes (shorter than international similar studies10%-20%）；6 Months ago83.3% PatientTR≤2+，97.2% PatientTR At least reduce1 Level,86.1% The patient's cardiac function has reachedNYHA I-II Level. Currently conducting the first-ever in ChinaT-TEER Randomized Controlled Trial (236 Example patients), filling the gap in evidence-based data for Chinese patients.
MicroPort CardioFlow
VitaFlow® Two Major Study Results of the Transcatheter Aortic Valve System Series Released, Focusing on Treatment for High-Risk Patients with Complex Anatomy.
VitaFlow® Ⅲ Controllable Bend Delivery System: The World's First 3D Adjustable Bend, RetrievableTAVI Delivery System, First-in-Human Study (6 Example: High-risk and ComplexAS Patient)30 The follow-up showed that the success rate of the surgery was100%, without complications such as vascular injury or coronary artery obstruction; the transvalvular pressure gradient decreased from75.5±12.3mmHg Reduce to7.9±2.1mmHg, effective orifice area from0.61±0.15cm² Increased to2.26±0.34cm²（P<0.001), without moderate or severe paravalvular leakage,30 No deaths or strokes occurred, and all patients achieved cardiac function.NYHA I/II Level.
VitaFlow® System Long-term Outcomes (VITAL Test):8 Annual follow-up data shows,110 Severe High Surgical RiskAS Patient (BAV 42 Example,TAV 68 Example) All-cause mortality39.1%, Cardiovascular Mortality20.6%`, Aortic Valve Reintervention Rate`2.3%; Structural valve degeneration (SVD) Incidence Rate1.41%, Bioprosthetic valve dysfunction (BVD) Incidence Rate14.04%，BAV WithTAV No significant difference in clinical outcomes and valve durability, validating its long-term safety and efficacy.
(III) Imaging and Auxiliary Technology:AI Empowerment and Safety Protection Innovation
United Imaging Healthcare
PublishAI Coronary Enhancement Technology and "Zero Noise"DSA Technology systematically addresses the two major pain points of "contrast-induced nephropathy" and "radiation exposure" in interventional treatments. Relevant research was jointly published by teams from Fuwai Hospital, Zhongshan Hospital Affiliated to Fudan University, and others.
AI Coronary Enhancement Technology: Integrated into United ImagingDSA uAngio AVIVA AnduAngio 960, through an end-to-end neural network model, only requires50% Concentration Contrast Agent, Imaging Quality Close100% Concentration Effect. A Prospective Single-Center Trial (38 Example patients) showed a consistent rate of vascular diameter stenosis judgment.94.75%（R=0.97，P<0.01), The consistency rates of the minimum lumen diameter, lesion length, and reference vessel diameter all exceeded92%, providing a safe alternative for patients with kidney disease, advanced age, and complex conditions.
"Zero Noise"DSA Technology: Drawing on Computational PhotographyBurst Denoise Technology, Improved Spatial Resolution57%, Signal-to-noise ratio improvement4.6 Times, radiation dose reduced70%. Phantom Study (126 The results of the recent collection showed that the overall radiation dose of the staff was reduced.71.8%, The First Surgeon Reduction78%`, Technician`73%, Second Surgeon70%`, Anesthesiologist`66%, the maximum reduction in liver position projection angle is81.84%; Real-world Study (382 Example patient) confirmed that, inCAG, SimplePCI Reduced Radiation Dose48%-62%, ComplexCTO Intraoperative Reduction60%-74%, and the image quality score was significantly better than that of traditional technology (3 Pointsvs 2 Points,P<0.01）。
MicroLight Medical
First ExhibitionTCT 2025, DisplayP80 OCT System and "one-stop diagnosis" clinical solutions, becoming the first in China to achieve coronary arteryOCT System Overseas Enterprises.
The product has been in China for nearly300 Clinical application in hospitals,2023 Entering overseas markets since the year,Currently has been8 Sales and installation in countries and regions;2025 Year4 Monthly Acquisition: United StatesFDA 510 (k) Approval, product performance aligned with international standards, simplifying the global market access process. During the exhibition, its integrationAI FunctionalOCT The system attracts international top experts to exchange ideas, and deeply discusses clinical applications and technical cooperation, gradually establishing the international brand influence of "China Imaging".
(4) Chinese Research Team: Leading in Clinical Translation and Evidence-Based Research
China's top scientific research teams become the core driving force for the clinical transformation of original devices:
Academician Gao Runlin Leads Yuanxin TechnologyIBS® Stent Series Clinical Trials, Organized Nearly Across China40 Home-based participation, with a large sample size and a high proportion of complex lesion enrollment, lays the evidence-based foundation for global product registration;
Academician Ge Junbo's Team Leads Huihe MedicalK-Clip® TriStar-RCT Trial, Minimally Invasive Cardiac AccessVITAL The trial pushes China's interventional valve research to reach international standards;
Academician Wang Jian'an Team Leads Dejin MedicalDragonFly Dual-system clinical study leads innovation in mitral and tricuspid valve repair technology;
Professor Song Lei, Professor Wu Yongjian, Professor Mao Yi, etc. respectively represent the team to release United Imaging HealthcareAI Technology, Minimally Invasive Heart AccessVitaFlow® System and Qiyi Medical Perfusion Catheter Clinical Data Highlight Chinese Experts' Voice on International Academic Stage.
This conference features over a hundred research reports led or participated in by Chinese experts, covering all areas of interventional cardiology. Chinese innovation has made its mark through..."A closed-loop model driven by clinical needs and supported by evidence-based data for market entry," continuously delivering "China solutions" to the world.
# Heart Future · Observation
TCT2025 The results show that the global cardiovascular intervention field is moving towards the direction of "precisization, long-term effectiveness, and minimally invasive procedures."RDN The long-term clinical evidence for technology, valve intervention, calcified lesion treatment, and other fields is continuously improving, providing stronger support for clinical practice. Chinese enterprises and research teams have achieved a leap from "participation" to "having a voice" on the international stage through original device development and high-quality clinical research. The achievements of companies like Yuanxin Technology and academician Wang Jian'an's team demonstrate China's core competitiveness in the field of cardiovascular medical device innovation.
For medical device companies, collaborating with Chinese innovative enterprises can leverage their original technologies and clinical data to accelerate the globalization of product layouts; for investors, high-quality projects in China's cardiovascular innovation field (such as absorbable stents and valve interventional devices) already possess international competitiveness and are highly promising investment targets.
This SessionTCT2025 The technical breakthroughs and the rise of China's strength showcased at the conference provide vast opportunities for global cooperation in the cardiovascular field. Heart Future is willing to collaborate with...All PartiesJoin hands, focus on innovation, deepen cooperation, and jointly promote the advancement of cardiovascular medical technology, bringing benefits to more patients.
GCC2025
Cardiovascular Device Full Disease Solution
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