Source: Heart Future; Editor: Bai Xiaofei
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Recently,Abbott (NYSE: ABT)Announce itsTranscatheter Tricuspid Valve Repair Product (TriClip G4)Approved for marketing by the FDA, becomeThe World's FirstTranscatheter Tricuspid Valve Edge-to-Edge Repair Product Approved by FDA, itsFor the treatment of tricuspid regurgitation (TR) or tricuspid leakage。This approval follows the recommendation made in February 2024 by the FDA's Medical Device Advisory Committee's Circulatory System Devices Panel.The voting result of the group was 13 votes to 1, with no abstentions.Believes that the benefits of TriClip outweigh the risks。This is another major breakthrough in the field of structural heart disease following the FDA approval of Edwards' transcatheter tricuspid valve replacement, EVOQUE.
▲Source: Company's official websiteIn the field of tricuspid valve repair,Abbott's biggest rival remainsEdward's Transcatheter Edge-to-Edge Repair Product PASCAL PrecisionPASCAL Precision received CE approval in 2022. It is a device capable ofDevices for the treatment of both mitral regurgitation and tricuspid regurgitation。Although TriClip can only treat tricuspid regurgitation, the reputation accumulated by Abbott's mitral valve repair product MitraClip (used by more than 150,000 patients) may enable TriClip to compete with PASCAL Precision in the tricuspid field.In the edge-to-edge repair field, Abbott has a first-mover advantage, but Edwards offers a more comprehensive solution., the competition between the two giants has gradually begun.The voting results of the FDA Medical Device Advisory Committee's Circulatory System Devices Panel,Based on Clinical Data and Expert Testimony from the TRILUMINATE Pivotal TrialAbbott recently reported positive results from the TCT trial in October, including significant improvements in patients' quality of life and the excellent safety of the TriClip system.Abbott previously conducted the TRILUMINATE trial at 21 medical centers in Europe and the United States to evaluate the safety and effectiveness of TriClip in reducing tricuspid regurgitation. The trial results showed,86% of patients had at least a 1-grade reduction in tricuspid regurgitation severity, reaching the pre-specified efficacy endpoint.. At the 6-month follow-up,Three (4%) of the 84 patients experienced serious adverse events, reaching the pre-specified safety endpoint.Adhesions occurred in 5 of the 72 patients (7%).No perioperative death, conversion to surgery, device embolization, myocardial infarction, or stroke occurred during the trial.. The test confirmed,The TriClip system can safely and effectively reduce the degree of tricuspid regurgitation in patients, and significant clinical improvement can be achieved 6 months after the surgery.。After reviewing the clinical data from the TRILUMINATE pivotal trial and hearing expert testimonies, the FDA's Medical Device Advisory Committee Circulatory System Devices Panel voted on the safety, effectiveness, and risk/benefit profile of the TriClip system.Regarding the question of whether there is sufficient data to support safety, the expert panel passed with a 14:0 vote.。In order to reasonably ensure effectiveness, the expert panel voted 12 to 2 in favor.。Regarding the final question on benefits and risks, the voting result was 13 to 1 in favor.。"The co-principal investigator of the TRILUMINATE pivotal trial stated: 'In the TRILUMINATE pivotal trial, we found90% of patients who underwent tricuspid valve repair using the TriClip implant experienced significant improvement in the severity of tricuspid regurgitation."The safety of the surgery is guaranteed, and the quality of life for these patients has shown continuous improvement over one year. The TriClip system ushers in a new era of structural treatment for patients with severe tricuspid regurgitation."# The Competition Between Two ProductsTriClip G4 System (Abbott)The TriClip system was developed by Abbott based on another best-selling cardiac repair device, the MitraClip.MitraClip helps treat mitral regurgitation, a condition where blood flows backward through the valve with each heartbeat. Regurgitation is one of the most common valve diseases. After the MitraClip device is implanted in the patient, it can clamp the two leaflets of the heart in between, creating two smaller openings to prevent blood backflow.TriClip G4 features four sizes of clip heads, suitable for different types of patients.。The TriClip system utilizes the same clipping technology as the MitraClip system., clinicians can fix a portion of each valve in the patient's heart together and customize the surgical procedure according to each patient's unique valve. In addition,Abbott has also specifically designed a differentiated delivery system for implantation in the tricuspid valve., allowing the surgeon to grasp individually before fixation. During the surgery,The doctor will implant the TriClip system into the patient's heart through the femoral vein., using the edge-to-edge technique to clip part of the tricuspid leaflets together, reducing blood regurgitation.The TriClip system is delivered through the leg veins,Can repair the tricuspid valve and help blood flow in the correct direction, without the need for open-heart surgery.- Transcatheter Tricuspid Valve Repair, Without Extracorporeal Circulation (Without Cardiac Arrest);
- Allow real-time positioning and repositioning;
- Via the femoral vein approach;
- Can be used in standard catheterization laboratories or hybrid rooms;
- No preoperative CT scan required;
- Various sizes of chucks, suitable for different types of patients;
PASCAL PrecisionIt is one of the many transcatheter repair therapies developed by Edwards.Aimed at treating mitral and tricuspid valve diseases。PASCAL Precision includes PASCAL and PASCAL Ace implants., with independent grasping, non-traumatic clamping and closing functions, as well as the versatility of the implant, including the ability to elongate and navigate complex anatomical structures.PASCAL Precision With an intuitive catheter and handle design,With operability and stability, enabling precise navigation and implant delivery。PASCAL Precision Compared with Abbott's MitraClip and TriClipThe biggest advantage is that one system can treat two diseases.. When using PASCAL Precision, doctors canPatients with Mitral RegurgitationAchieve predictable capture, positioning, and release. Meanwhile, PASCAL Precision aids in treating challenging tricuspid valve anatomies.Patients with tricuspid regurgitation。Advantages of PASCAL Precision:- Extensive paddle mobility and full extension capability allow for manipulation, reconfiguration, and retrieval of the implant prior to release;
- Enhanced leaflet capture through non-invasive retrieval function;
- UltraElastic nitinol structures enable passive implant closure and dynamic implant bending;
- Responsive catheter design optimizes torque transmission for ease of implant placement.
- The handle control design makes operation more intuitive and convenient, allowing users to focus on treating patients.
Comparison of Design Between Two Different Products:Comparison of the Effectiveness of Two Different Products in Intervention and Repair of Severe Tricuspid Regurgitation:# Overview of the Tricuspid Valve Repair MarketAccording to data disclosed by Sullivan, the number of patients with tricuspid regurgitation is second only to those with mitral regurgitation, and it is expected to affect more than 50 million people worldwide in the future; in terms of prevalence (based on total population statistics),The prevalence of tricuspid regurgitation is above 0.62%, second only to mitral regurgitation and surpassing that of aortic stenosis.。In domestic community surveys,The prevalence of moderate or severe tricuspid regurgitation (TR) is as high as 0.55%, and exceeds 3% after the age of 75., similar to aortic stenosis or mitral regurgitation, has become one of the burdens of global public health diseases. In addition to the high prevalence,The severity of TR is also significantly correlated with mortality., only a small number of patients with severe TR undergo surgical intervention, usually performed concurrently with left heart valve disease or other cardiac surgeries.
▲ Originated fromFrost & Sullivan
On the other hand,Patients with tricuspid regurgitation have an extremely high mortality rate with conservative treatment, and surgical intervention is the most high-risk.Combined with the epidemiology related to valvular disease, the mortality rate of conservative treatment for severe tricuspid regurgitation is generally higher than that for severe mitral regurgitation.The mortality rates of patients with severe tricuspid regurgitation at 1 to 5 years are approximately 35%, 42%, 50%, 58%, and 66%, respectively, reaching 86% at 10 years.; The mortality rates for patients with severe mitral regurgitation at 1-5 years are approximately 20%, 29%, 37%, 46%, and 50%, respectively.
▲ Originated fromFrost & Sullivan
The perioperative mortality rate of TR patients is the highest among all valve surgeries.，The perioperative mortality rate of isolated surgical tricuspid valve replacement is as high as 10.9%.，Perioperative Mortality Rate of 8.1% for Isolated Surgical Tricuspid Valve Repair, which is several times higher than the perioperative mortality rates of isolated surgical mitral valve repair (1.4%–2.6%), mitral valve replacement (3.8%), and aortic valve replacement (2.2%). Therefore, there is an urgent need to develop safer and more effective treatments for tricuspid regurgitation.
Currently, the treatment options for TR are limited.No significant benefit from surgical tricuspid valve repair or replacement, and poor response to medical treatment. Left heart valve surgery combined with tricuspid valve repair may improve the prognosis of TR patients, suggesting the necessity of timely TR treatment. Recently, studies have shownTranscatheter Tricuspid Valve Intervention Shows Better Survival Rates and Lower Heart Failure Readmission Rates Compared to Conservative Drug Therapy Alone, preliminary confirming the effectiveness of interventional treatment.
In terms of surgical volume, according to Sullivan data forecasts,The Global Volume of Transcatheter Tricuspid Valve Interventions Will Increase from 340 Cases in 2021 to 450,000 Cases by 2030; andThe number of transcatheter tricuspid valve interventions in China is expected to surge from 600 cases in 2023 to 200,000 cases by 2030.。
▲ Originated fromFrost & Sullivan
In terms of market size,From 2021 to 2030, the global market size for tricuspid valve interventional devices will grow from USD 0.1 billion to USD 112.8 billion., with a CAGR of 118.35%;From 2023 to 2030, the overall market for tricuspid valve interventional devices in China is expected to grow from 0.9 billion yuan to 203.1 billion yuan, with a CAGR of 118.44%.; It can be seen that the growth rate of the transcatheter tricuspid valve market in China is relatively consistent with the global growth rate.Will all be in a state of rapid growth。
▲ Source: Frost & SullivanCurrently,Globally, only four tricuspid valve interventional treatment devices have received CE certification, two products have been approved by the U.S. FDA, and no products have been approved for marketing by China's NMPA.。
Based on the R&D experience of mitral valve repair,CE Certification ObtainedThe 4 products include the edge-to-edge repair (T-TEER) pathway.Abbott TriClip, Edwards PASCAL, Edwards Cardioband for annuloplasty, and a heterotopic replacement option from Germany, PF TricValve.；Obtaining FDA ApprovalThe product is from Abbott.Abbott TriClip, EdwardsEVOQUE。
Similar to mitral valve, T-TEER is currently the most widely used TTVr technology internationally. The safety, availability, and usability of TriClip and PASCAL have been supported by evidence from some clinical studies.From the perspective of global product approvals, the progress of tricuspid valve replacement devices has been relatively slow, with onlyEdward's EVOQUEReceived FDA approval in February 2024,Becoming the First Approved Tricuspid Valve Replacement Device。
As of now, no tricuspid valve interventional products have been approved in China., but several leading companies have launched R&D and registration efforts around tricuspid valve interventions, among whichLuX-Valve and LuX-Valve Plus products independently developed by Jian Shi TechnologyWith unique designs in stress structure, leaflet clamping, septal anchoring, and delivery systems, it has achieved significant competitive advantages.Currently under NMPA review, with the hope of being approved in 2024 to become the first of its kind in China., enjoying a 3-year exclusivity period.
However, on March 28, 2023, Jianshi Technology revealed in a thematic exchange meeting for investors that,The company's transcatheter tricuspid valve replacement product, LuX-Valve, has not yet received NMPA registration at this stage.(NMPA) approval, the final registration results will be subject to further internal review and decision by the NMPA, which may require additional clinical evidence.
Regarding the reason why LuX-Valve was not approved, an industry insider explained that"Now the FDA requires all tricuspid valve products to be compared with drugs in control studies, but current clinical trials do not have control groups, so they will all be returned for re-clinical trials."
In addition to Jian Shi Technology,Shanghai Huihe MedicalIt is also developing a transcatheter tricuspid annuloplasty repair system, K-Clip. The company stated,K-Clip has entered the "Green Channel" for special review of innovative medical devices in China, completed registration clinical research, and submitted a registration application to the National Medical Products Administration (NMPA), with the expectation of being approved this year.。
VenusP Cardiovalve for Mitral and Tricuspid Valve ReplacementHas entered pivotal clinical trials, with over 40 patients enrolled in Canada, Europe, and other regions as of mid-2023, showing significant progress;Peijia Medical's Tricuspid Valve Replacement Product MonarQCompleted the first human implantation in the United States, expected to initiate clinical enrollment;Nuvalve Medical's Tricuspid Valve Replacement Product Prizvalve-THas entered the design phase;Hanzee Medical's Tricuspid Valve Replacement System ValveNeo-TCurrently undergoing prototype iteration;BalRen Medical's Surgical ValvesHas also begun the early first-in-human clinical trial.
# Global Products Compete FiercelyTranscatheter tricuspid valve repair mainly includes leaflet edge coaptation and annuloplasty.Leaflet edge-to-edge repair primarily helps enhance coaptation and reduce tricuspid regurgitation through edge-to-edge repair (T-TEER), reflux orifice occlusion, and chordae tendineae wrapping.T-TEER is currently the most widely used repair treatment technology. Under this technology, two products have received CE certification: TriClip (Abbott) and PASCAL (Edwards).。Reflux Port OcclusionThe representative product isFORMA (Edward), the product reduces reflux by placing a spacer at the reflux port.Due to its unsatisfactory long-term outcomes, the product pipeline has been terminated.。Tendon WrappingIt is a new technical approach aimed at enhancing coaptation by capturing the chordae tendineae of the tricuspid valve. The representative product is Mistral（Mitralix）. This product is easy to operate, not limited by the reflux hole, and only requires ultrasound imaging of the chordae tendineae before surgery. However, its long-term efficacy still needs to be verified.Transcatheter Tricuspid Annuloplasty is an interventional procedure derived from surgical methods, mainly including Ring Annuloplasty and Suture Annuloplasty.Representative products of annuloplasty mainly include Cardioband (Edwards), Millipede IRIS (Boston Scientific), and TRAIPTA.; andThere are many products under the category of sutureoplasty, mainly including: K-Clip (Huihe Medical), Trialign (Mitralign & Cardi-Tech), TriCinch (4Tech Cardio), Transcatheter Assisted Suture Tricuspid Annuloplasty (PASTA), and MIA-T Minimally Invasive Annuloplasty (Minimally Invasive Annuloplasty Technology, MIA) (Micro Interventional Devices).This type of product is mainly applicable to early secondary tricuspid regurgitation. In terms of recurrence of regurgitation, annuloplasty is superior to suture plasty.。For mid-term secondary tricuspid regurgitation, the effect of using it alone is relatively poor, and it can be combined with T-TEER for treatment.In addition, due to the anatomical position of the tricuspid annulus being close to the His bundle and the ostium of the right coronary artery, adverse reactions such as myocardial infarction, perforation of the right coronary artery, conduction block, and severe bleeding may occur after implantation.▲Overview of Characteristics of Interventional Repair ProductsAccording to the design concept, interventional replacement products can be divided into in-situ replacement and ectopic replacement.In-situ ReplacementIt is to place the artificial valve in the anatomical position of the native tricuspid valve., replacing its function, eliminating systolic regurgitation, reducing right atrial pressure and right ventricular preload, thereby improving systemic circulation congestion and reversing right ventricular remodeling,Representative products includeEVOQUE (Edwards), GATE (NaviGate), LuX-Valve (Plus) (Jian Shi Technology), Cardiovalve (Cardiovalve & Qiming Medical), and Intrepid (Medtronic)。Such products are superior to repair products when used in cases such as effective regurgitation orifice area and commissural gap being too large, significant annular dilation, severe leaflet tethering, non-central/anterior-septal commissural regurgitation, pacemaker lead directly compressing the septal leaflet, leaflet calcification or iatrogenic injury, and tricuspid stenosis.Heterotopic ReplacementThis involves implanting an artificial valve into the superior and/or inferior vena cava., reduce venous reflux, and improve systemic circulation congestion, but it may not help with right ventricular reverse remodeling and functional recovery, and is more often used as a supplementary approach to TTVr or orthotopic TTVR in palliative treatment.Representative products includeTricValve (P + F GmbH), Tricento (Bluesail Medical & New Valve Technology), and Sapien XT (Edwards)。▲Overview of Interventional Replacement Product FeaturesAbbott (NYSE: ABT) is a global healthcare company founded in 1888, with its headquarters located in Chicago, USA. After a century of development, the company has now become a Fortune 500 enterprise with diversified pharmaceutical and nutritional products.
AbbottBusiness spans across more than 160 countries and regions worldwide, with nearly 110,000 employees., with products covering the fields of nutritional products, pharmaceuticals, medical devices, diagnostic instruments, and reagents.
The Fourth Quarter of 2023,Abbott's global medical device sales reached $4.4 billion, a year-on-year increase of 15.4%.。The business's total sales for the year reached $16.9 billion, a year-on-year increase of 14.2%.Among them, the sales of diabetes, neuromodulation, structural heart disease, electrophysiology, and heart failure businesses all achieved double-digit growth in the fourth quarter.
