Medtronic Receives NMPA Approval for SimuForm™ Dynamic Mitral Annuloplasty Ring

May 05, 2024 10:40 CST Updated 10:40

Medtronic

Chronic Disease Medical Device and Therapy Developer

Source: Heart Future (partially referenced from Yi Xin); Editor: Bai Xiaofei

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart to the Future

Recently, according toMedtronic（NYSE：MDT）Claimed that its mitral valve repair productSimuForm Mitral Valve Annuloplasty RingAlreadyApproved for marketing by NMPA(Registration Certificate No.: China Medical Device Registration Approval 20243130214).

SimuForm™ Semi-Rigid Ring, AdoptingDynamic Design, showing a saddle shape during cardiac systole and an O-shape during diastole after implantation,Maximally conform to the physiological characteristics of mitral valve motion, significantly improving the therapeutic effect of valve repair.。

# Mitral Annuloplasty

In terms of mitral valve repair, transcatheter mitral valve repair has become a future development trend. Among these, the edge-to-edge repair technique based on the mitral valve leaflets is the most mature and represents the current mainstream repair approach.

However,Although the "edge-to-edge" repair of the mitral valve leaflets has achieved great clinical success, this technique is not without its imperfections., other different mitral valve repair techniques continue to emerge. Transcatheter mitral annuloplasty is a technique that competes with the "edge-to-edge" repair of the mitral valve leaflets. Unlike transcatheter edge-to-edge repair of the mitral valve,Annuloplasty interventional products have high technical barriers, are difficult to operate, and have a long learning curve.，It is one of the most technically challenging procedures, and its development has also been relatively slow.。

Compared with mitral valve replacement, mitral valve repair has two advantages.：

(1) Avoid anticoagulation

For young patients, valve repair does not require anticoagulation, whereas replacement with a mechanical valve necessitates it. Mechanical valves may lead to thromboembolic complications (causing stroke and valve failure) and spontaneous bleeding (due to anticoagulation), which are not associated with valve repair.

(2) Preservation of Cardiac Function

Many clinical and laboratory studies have demonstrated that valvuloplasty preserves cardiac function, while valve replacement results in a 15%-20% reduction in left ventricular function. Valvuloplasty maintains the interaction of ventricular muscle structures and the pulley mechanism of the valve, whereas both are disrupted during valve replacement.

According to different working mechanisms, annuloplasty can be divided into direct annuloplasty and indirect annuloplasty.。

(1) Indirect shaping

Indirect annuloplasty involves placing a device between the coronary sinus ostium and the distal coronary sinus, then using a connector to tighten the coronary sinus, thereby reducing the mitral annulus. However, due to the risk of compressing the circumflex artery and causing coronary artery obstruction, it was not further promoted clinically after being approved in 2009.

(2) Direct Forming

Direct annuloplasty, on the other hand, reduces mitral regurgitation by implanting a device within the heart chamber that can reduce the annulus or by directly implanting a shaping ring.

Currently, both types of annuloplasty are only used for patients with functional mitral regurgitation.

# SimuForm Mitral Valve Annuloplasty Ring

▲SourceCompany Official Website

The mitral annulus presents different shapes at different stages of the cardiac cycle.Systolic phase shows a saddle shape, while diastolic phase is "O" shaped.. According to Medtronic,SimuForm™ Shaping Ring is not fixed in a saddle shape; instead, it can change its shape during contraction and relaxation.。Due to the anterior portion of the forming ring being movable, the saddle shape during systole can enhance leaflet coaptation and curvature, reducing stress on the leaflets and chordae tendineae. During diastole, it assumes an O-shape, adapting to the hemodynamics of diastolic filling.

The size range of the SimuForm™ shaping ring is 24-40mm.。

# Comparison of Products in the Same Track

Carillon System

The Carillon system (Cardiac Dimensions, USA) consists of proximal and distal self-expanding anchors, which are connected by formed bands made of nickel-titanium alloy. It is delivered through a 9F catheter from the internal jugular vein to the high-riding coronary sinus, partially encircling the posterior mitral valve annulus, thereby reducing its diameter.The system received CE certification in 2011.。

The Carillon device is designed for patients with symptomatic heart failure, dilated cardiomyopathy, and moderate to severe secondary mitral regurgitation.Since the device does not affect the mitral valve leaflets, it can be considered for use in combination with other mitral valve repair devices.。

The clinical trial REDUCE-FMR related to the Carillon system enrolled 83 patients with severe MR.The inclusion criteria were obvious mitral regurgitation symptoms (MR grade ≥2+) with left ventricular ejection fraction <50% and left ventricular end-diastolic diameter >55 mm. The experimental group consisted of patients treated with the Carillon device (62 cases), while the control group received sham surgery (21 cases). There was no statistically significant difference in baseline characteristics between the two groups.All clinical data at the 1-year postoperative follow-up showed that the experimental group was superior to the control group.。

Cardioband System

The Cardioband system (Edwards Lifesciences, USA) is advanced into the left atrium via a femoral vein-transseptal approach after puncture, and following deployment, the internal annuloplasty ring is cinched by rotating the terminal coil to shorten the wire within the annulus, thereby reducing the annular size.The device received CE certification in 2015.。

The Cardioband system is suitable for patients with secondary functional regurgitation who have LVEDD ≤70 mm, Charpentier Type I (annular dilation/deformation), and Type IIIB.

A multicenter study involving 60 patients evaluated the performance and safety of the Cardioband system.The immediate technical success rate was 97%, and postoperative 30-day follow-up data showed 2 cases (4.9%) of death., and one patient requires elective reoperation. Among them, the degree of MR in over 90% of patients decreased to ≤2+.

Millipede IRIS System

Millipede IRIS (Boston Scientific, USA) is aSemi-Rigid Percutaneous Atrial Septal Occluder SystemThe system consists of eight stainless steel anchors, each of which can be reversibly fixed to the mitral valve tissue, allowing the mitral annulus to contract and reshape.

The first clinical trial of the Millipede IRIS system enrolled 7 patients, 4 of whom were implanted through surgical procedures.A success rate of 100% with no device-related complications.At 30 days post-operation, all patients' reflux levels decreased from preoperative 3+~4+ to 0~1+, with improvement in NYHA classification and significant reverse remodeling of the left ventricle.

Mitralign System

The Mitralign system (Mitralign, USA) is aTranscatheter Direct Mitral Valve Plasty System, the catheter enters the left atrium through the femoral artery approach, then orients towards the posterior leaflet of the mitral valve, and anchors at the P2/P3 fold of the posterior leaflet. The suture is then tightened to reduce the diameter of the mitral valve annulus.

The Mitralign system is suitable for patients with LVEF≤25%, regurgitation degree 2-4+, and symptomatic functional mitral regurgitation.

The first-in-human study and a follow-up study of 71 patients with moderate to severe MR both indicated that,Mitralign is feasible and safe in high-risk patients with functional MR. The device success rate was 70.4%.，With the use of the second-generation device, the success rate has improved.The all-cause mortality rates at 30 days and 6 months were 2 cases (4.4%) and 5 cases (11.6%), respectively.50% of patients showed a significant reduction in reflux at 6 months.The 6-minute walk test improved, and the percentage of patients with NYHA Class III-IV symptoms decreased from 53.3% to 23.3%. Major adverse events included death, stroke, and cardiac tamponade.

MVRx ARTO System

MVRx ARTO (Ample Medical Inc., USA) is aIncomplete Indirect Annuloplasty SystemThe system consists of two magnets (MagneCath). They pass through the cardiac cavity and anchor in the interventricular septum and the lateral wall of the myocardium. By adjusting the length, they displace inward, shorten the minor axis of the mitral valve, directly remodel the mitral valve annulus, and improve leaflet coaptation.

The ARTO system treats heart failure by reducing the backflow of blood through the mitral valve, thereby increasing blood flow to other parts of the body.The system shortens the mitral valve minor axis through inward displacement of the interventricular septum and lateral wall, directly reshaping the mitral valve annulus and improving leaflet coaptation. This reconstructs the normal anatomical relationship and reduces regurgitation.

The MAVERRIC clinical study enrolled a total of 45 patients., all of whom had MR severity ≥2+ (including 32 cases with MR severity ≥3+), NYHA cardiac function classification ≥Class II, and were unresponsive to drug therapy.Clinical data at 30 days post-operation showed that the reflux orifice area of the included patients decreased from 30.3 mm.²Reduced to 13.5 mm², reflux volume decreased from 45.4 ml to 19.5 mlThe diameter of the mitral valve annulus decreased from 45.0 mm to 38.7 mm;Two-year follow-up results showed no device-related deaths.Among the 31 patients who participated in the follow-up, 21 (67.7%) had MR severity still ≤2+. This demonstrates that the treatment effect of the MVRx ARTO system is relatively ideal.

Valcare Amend SystemUnified

Valcare Amend System (Valcare Medical, Israel) is aComplete, Semi-Rigid "D"-Shaped Transcatheter Annuloplasty System, which can be performed via a transseptal or transapical approach. The ring is available in three sizes to accommodate various mitral annulus dimensions (29~50 mm). The Valcare Amend annuloplasty system has been used in combination with other interventional mitral valvuloplasty devices in different scenarios and has undergone clinical trials.

AMEND can also be used as part of the Valcare mitral valve replacement system and tricuspid valve repair solutions.AMEND allows for the preservation of the original valve anatomy and function, and can be implanted without stopping the heart during surgery.。

In 2022, a case of a 78-year-old patient was reported, with preoperative NYHA class III heart function, and echocardiography showed severe MR caused by mitral annulus dilation.Recovering Well After Valcare Amend System Plasty Treatment, pre-discharge echocardiography and CT both indicated stable position of the mitral valve annuloplasty ring. At the 3-month postoperative follow-up, the patient was classified as NYHA functional class II,MR has decreased to mild-moderate.。

Mitral Valve Annuloplasty Ring (BalRen Medical)

This product is based on the clinical practice experience of Balloon Medical's original valve annuloplasty ring products and adoptsSemi-rigid physiological ring structure design and elastic alloy materialsManufacturing, aligning with the latest generation of imported mitral valve annuloplasty rings,Not only can better mitral valve repair results be achieved, but also the concept of whole life cycle management for valvular disease patients is taken into account., is developed to meet the potential future need for subsequent reintervention treatment in the mitral valve.Product Upgrade。

CompanyThe valve annuloplasty ring product was first approved for registration and market launch in January 2005., filling the gap in valve repair products in China.Since its launch nearly 19 years ago, the product has been implanted in approximately 100,000 patients., restoring valve function and avoiding valve replacement, promoted the development and popularization of valvuloplasty in China.

Thus, the upgraded mitral annuloplasty ring, together with the new tricuspid annuloplasty ring registered by the company last year,Completed the upgrade of domestically produced mitral and tricuspid valve repair products., High-end products have reached a new level in achieving full domestic substitution.

# About Medtronic

Medtronic (Medtronic, NYSE: MDT) was founded in 1949, with its headquarters in Minneapolis, Minnesota, USA. It is a global leading medical technology company, employing over 95,000 people.

Medtronic's innovative solutions have expanded to more than 70 key disease areas, committing to provide lifelong treatment options for patients with chronic conditions. Every second, two patients worldwide benefit from Medtronic's medical technology or therapies.

Medtronic's main businesses includeCardiovascular, Medical Surgery, Neuroscience, and DiabetesFour business blocks, includingCardiovascular accounts for the highest proportion。What Does Medtronic Sell? A Comprehensive Overview of the Cardiovascular Product Line

Taking the 2023 financial report as an example, the company's total revenue was $31.227 billion, ranking first in revenue among global medical device companies. Among this, the cardiovascular business revenue was $11.573 billion, accounting for 37.06%, includingCardiac Rhythm and Heart Failure (CRHF), Structural Heart and Aortic (SHA), and Coronary and Peripheral Vascular (CPV)Three departments.

▲2023 Annual Report (Source: Company Official Website)

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