First-in-Human Implant Success: PulveClip™, a Novel Chinese-Developed Transcatheter Mitral Valve Repair System, Enters Pivotal Clinical Trial

Mar 09, 2024 11:13 CST Updated 11:13

PushMed

Supplier of Cardiovascular and Cerebrovascular Interventional Medical Devices

Source of the article:Heart NotCome;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 Future

Recently, the cardiology department of the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), led by Professors Guo Zhifu and Qin Yongwen,Interventional Treatment Team for Valvular Heart Disease, under the cooperation of Professor Wang Jiafeng from the Department of Anesthesiology, applied byShanghai Push Medical Devices Co., Ltd.Developed byTranscatheter Mitral Valve "Edge-to-Edge" Repair System (PulveClip™)Successfully Completed NationwideFirst Surgical Procedure in Pre-Market Clinical Study。

This isFirst ProductLed by Professor Qin Yongwen in its developmentTransfemoral Mitral Valve Repair Products, from "concept birth" to "clinical implantation"In just over three years。

The surgical procedure went smoothly this time.The patient's mitral regurgitation significantly improved.. This marksClinical Trial of PulveClip System Officially Launched, will further explore the safety, efficacy, and unique clinical advantages of this original device.

# Patient Details

The patient is a 70-year-old woman who was transferred to Changhai Hospital from another city due to recurrent chest tightness and shortness of breath, making it impossible for her to lie flat. After being seen by Associate Professor Bai Yuan from the Cardiovascular Medicine Department, she was diagnosed withSevere Regurgitation Caused by Mitral Valve Prolapse, and the patient simultaneouslyWith multiple comorbidities such as atrial fibrillation and coronary heart disease。

In December 2023, after being seen by Professor Bai Yuan from the Cardiology Department of Changhai Hospital, the patient first underwent coronary angiography + PTCA + PCI surgery, and was simultaneously treated with optimized GDMT medications; however, the patientRepeated episodes of chest tightness, shortness of breath accompanied by palpitations and fatigue after discharge, with dyspnea on exertion.After a comprehensive evaluation by Director Guo Zhifu's team, the patient was admitted for treatment.

After evaluation,The patient's STS score for surgical valve replacement is 8.81%, indicating a high-risk surgical patient.。

# Surgical Strategy and Procedure

After evaluation by the cardiac center team, it was considered that the patient had a high risk of undergoing open-chest cardiac surgery, and therefore, it was recommended to adoptVia the Femoral Vein PathwayProceedMitral Valve "Edge-to-Edge" RepairIs the best surgical method for this patient, and the final decision is to choosePulveClip™ Transcatheter Mitral Valve Clip System Performs "Edge-to-Edge" Repair Surgery。

Preoperative Strategy ForecastFirst, use two mitral valve clips., the first mitral valve clip selects the PulveClip long and wide clip to clamp zone 3 first, then chooses either the PulveClip long and wide clip or the PulveClip long and narrow clip based on the remaining valve orifice condition, clamping the leaflets towards the outer side.

After the patient was under general anesthesia, a right femoral vein approach was established. Under the guidance of transesophageal echocardiography, the atrial septum was punctured precisely at a height of 4.5 cm, thenAdvance the steerable guiding catheter and PulveClip mitral valve clip delivery system into the left atrium.。The operation time of intraoperative instruments is about 60 minutes.`, Patient`Patients can get out of bed and move independently on the second day after surgery, with significant improvement in clinical symptoms.Good.

▲Final reflux (left) and disappearance of pulmonary vein retrograde flow (right)

# PulveClip Transcatheter Mitral Valve Edge-to-Edge Repair System

▲PulveClip Transcatheter Mitral Valve Edge-to-Edge Repair System

PulveClip Transcatheter Mitral Valve Edge-to-Edge Repair System byPushMed Collaborates with Professors Qin Yongwen and Pan XiangbinJointly developed and adoptedMechanical self-locking structure, instant stop and clamp, which is safe and reliable, possesses both the firm mechanical locking of MitraClip and the self-locking function of the PASCAL system, eliminating any concern about locking failure.

A slide-track opening and closing structure can achieve a longer clamping arm length while maintaining a smaller implant size.PulveClip One-Touch Release Solution, significantly improving the safety and convenience of clinical operations; the capture arm can independently capture, suitable for more anatomical structures.。

# Global Market Overview of Mitral Regurgitation

Mitral regurgitation (MR) accounts for 65% of the prevalence of all mitral valve diseases.The incidence rate increases progressively with age, and in Western countries, about 10% of the population aged over 75 are affected. In terms of the number of surgeries, the United States...Only 2% of MR patients undergo surgical procedures., 49% of MR patients did not receive surgery due to factors such as low cardiac function, multiple comorbidities, and advanced age leading to high surgical risk, and another 49% of MR patients did not receive treatment because they did not visit the hospital.

Currently, the treatment for mitral regurgitation disease focuses onTranscatheter Mitral Regurgitation Intervention as the Main Treatment, mainly including: transcatheter mitral valve repair (edge-to-edge repair, annuloplasty, chordae repair, ventricular remodeling) and transcatheter mitral valve replacement. Among them,Transcatheter edge-to-edge repair is currently the transcatheter mitral valve repair method with the most clinical evidence internationally.。

In 2023, the global implantation volume of transcatheter mitral valve edge-to-edge repair (M-TEER) increased rapidly,A total of 220,400 cases were implanted throughout China.. It took 16 years from the first implant to exceeding 100,000 implants, and only 3 years to exceed 200,000 implants, which can be seenOutM-TEER has experienced explosive growth., presenting a situation of leapfrog development.

Due to the high technical barriers in transcatheter mitral valve (TMV) interventions, there are currently only a few manufacturing enterprises globally, mainlyAbbott, Edwards, Cardiac Dimensions, Mitralign, NeoChord, etc., are all American companies.Currently, in the M-TEER field,Globally, there are 2 products that have received certification from the U.S. Food and Drug Administration (FDA) and European CE, respectively.MitraClip and PASCAL。

MitraClip is in the TEER fieldThe only product approved for marketing by China's National Medical Products Administration (NMPA)products since MitraClip was launched in China in 2020,In China, more than 2,000 TEER procedures have been cumulatively performed, and over 150 centers have implemented TEER technology.。

▲MitraClipTranscatheter Mitral Valve Clip and Steerable Guide Catheter

MitraClip G4 is its latest generation product, and the 1-year results of Expand G4 announced at the TCT conference in October 2023 showed,A study was conducted on 1,164 patients in the real-world application of the MitraClip G4.92.6% of patients had MR ≤ Grade 1 one year after surgery., significantly improving patients' cardiac function and quality of life, and setting a new standard for TEER therapy.

Another relatively mature TEER device is PASCAL,Currently, the global cumulative implantation has reached 4,170 cases., the randomized controlled trial CLASP IID study comparing it with MitraClip is currently underway, whileSome registration studies have shown its good efficacy and safety., as well as non-inferior efficacy compared to MitraClip.

▲PASCAL Precision Transcatheter Valve Repair System

Since the first successful use of the MitraClip system for TEER technology to treat mitral regurgitation (MR) in 2003, with the continuous updates of devices and the ongoing release of evidence-based research,TEER technology has become the most mature transcatheter MR interventional treatment method currently available.. At the same time, TEER technology is also continuously expanding to patients with tricuspid regurgitation (TR).

# Overview of the Mitral Regurgitation Market in China

The intervention rate for mitral regurgitation in China is the lowest among all isolated VHDs, with an average annual mortality rate of 7.2%.From this, it can be seen that the high incidence of mitral regurgitation, low intervention rate, and poor prognosis are the main problems currently faced, which urgently need to be resolved.As can be seen from the clinical application data, in 2021, only 182 cases of TEER were completed in China.This number has grown to 1,274 cases in 2023, achieving a breakthrough development.。

In terms of the provinces where TEER (MitraClip) was performed in 2023, Guangdong Province ranked first with 197 cases, followed by Beijing with 162 cases, and Zhejiang with 119 cases. In addition, provinces such as Sichuan, Shandong, Liaoning, Fujian, Henan, Jiangsu, and Shaanxi have also been gradually carrying out the procedure.TEER is gradually showing a trend of blooming in multiple places in China.。

In 2023, two domestically produced devices were approved for marketing in China: Valveclamp by捍宇医疗 and Dragon fly-M by德普医疗.. At the same time, the self-developed TEER devices produced in China are just beginning to emerge, mainly includingPulveClip、NovoClasp, Valveclasp, SQ-Krine, ValveClip, Neonova, Kokaclip, Jensclip, etc.

In September 2023, ValveClamp was successfully approved for marketing.ForChina's First Minimally Invasive Interventional Device for Mitral Regurgitation Manufactured in China。

ValveClamp is alsoThe World's FirstTranscatheter Mitral Valve Clip, already inApplied in more than 50 hospitals nationwide, with over 400 patient cases, achieving satisfactory results. The results of the CLAMP-2 study, a national multi-center pre-market clinical trial in China, indicate that,Immediate surgery success rate as high as 97%, 88% of patients need to implant one clipping device to achieve the treatment goal; one year after the surgery,87.3% of patients reached the effective endpoint.(MR≤2+, and no death or surgical intervention).

Moreover, ValveClamp has already gone beyond China's borders, embarking on a "Belt and Road" heart-protection journey. On November 10, 2023, inIndonesia Conducts First Implantation。

▲ValveClamp® Mitral Valve Clip System

Dragonfly is the first Chinese-made transvenous edge-to-edge repair device., led by Professor Wang Jian'an's team in the development. The DragonFly NMPA registration clinical trial is a prospective, single-arm, multi-center study, enrolling patients with moderate to severe or severe MR, and conducting trials separately in DMR and FMR groups.

The results of the DMR group study published in June 2023 showed,The success rate of patient surgery is 99.2%.，The patient's reflux severity significantly improved.At 1 year, 92% of patients had a reflux degree ≤2+, 93.8% of patients were in NYHA class I/II, with significant improvements in KCCQ scores and left ventricular volume. Relevant trials for the FMR patient group are currently ongoing.

November 2023,Dragonfly Officially Approved for Marketing by NMPA. The current research results are close to the latest results of MitraClip and PASCAL,Indicates its good efficacy。At the same time, in 2023, DragonFly continuously appeared at major domestic and international conferences such as EuroPCR, TCT, CSI, AP Valve, and international journals like JACC, gaining recognition from experts both in China and abroad.

▲DragonFly™ Transcatheter Mitral Valve Clip System

In addition, other TEER devices in China includeDeveloped by Shanghai Push Medical Devices Co., Ltd.Transcatheter Mitral Valve "Edge-to-Edge" Repair System PulveClip, alreadySuccessfully Completed the First Surgery of the Pre-Market Clinical Study in China。Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Xiamen University Affiliated Cardiovascular Hospital jointly initiatedNeoNova Transcatheter Mitral Valve Edge-to-Edge Repair Device, has been in January 2023Passed the NMPA Special Review Application for Innovative Medical Devices; and the General Hospital of the Northern Theater Command taking the leadSQ-Kyrin-M, for the treatment of moderate to severe or severe functional mitral regurgitationIdeal 1-Month Follow-Up Results from the Confirmatory Clinical Trial。

AboutPushMed

Shanghai Push Medical Devices Co., Ltd. was established in 2012.Integrated with R&D, manufacturing, and salesCardiovascular and Cerebrovascular Interventional Medical DevicesSupplier.The company has a variety of cardiovascular medical devices for promotion.Covering 850+ hospitals across 31 provinces in China, the core product, the left atrial appendage occluder, leads in market share in China.

Based on the micro-needle integrated processing technology, the company'sLACbes Left Atrial Appendage Occluder was granted the "Special Approval for Innovative Medical Devices" by the China Food and Drug Administration in 2017 and was approved for marketing in 2019.In addition, the developed Patent Ductus Arteriosus Occluder (PDAO), Atrial Septal Defect Occluder (ASDO), Ventricular Septal Defect Occluder (VSDO), occluder interventional delivery system (Delivery System), and Snare have been widely used in major hospitals across China.

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