China's First Domestically Developed Balloon-Expandable Transcatheter Aortic Valve System Prizvalve® Approved for Market Launch by NMPA

Aug 16, 2024 09:51 CST Updated 09:51

NewMed

Artificial Heart Valve System Developer

Source of the article: Siyu MedTech; Editor: Seven Kite

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Recently,Shanghai NewMed Medical Co., Ltd. ("NewMed")Independently DevelopedPrizvalve Transcatheter Aortic Valve System (“Prizvalve”)Approved for marketing by the National Medical Products Administration (NMPA) of China。

This product, asThe First Self-Developed Balloon-Expandable Valve in China to Hit the Market, applicable to patients with symptomatic, calcified, severe degenerative native aortic valve stenosis who, after assessment by the cardiac team in conjunction with a scoring system, are considered unsuitable for conventional surgical valve replacement.

# Prizvalve® Valve System

Prizvalve^®The system isChina's First Balloon-Expandable Transcatheter Aortic Valve with Independent Intellectual Property Rights, is a product successfully developed after years of joint technical efforts by Shanghai NewMed Medical, the team of Academician Xingdong Zhang from the National Engineering Research Center for Biomaterials, Huaxi Hospital, Xijing Hospital, and other medical teams.

The Prizvalve valve system features bovine pericardial leaflets and a skirt design with a lower stent height, whichEffectively Reduce Pacemaker Implantation Rate, improve hemodynamics, and better adapt to vascular morphology,Reduce the Risk of Post-implantation Complications。

The product is available in four models, with specifications of 20 mm, 23 mm, 26 mm, and 29 mm.Product Features：

Using cobalt-chromium alloy with good biocompatibility as the valve frame material, the inner and outer edges of the frame are sewn with PET fabric skirts.Effectively reduce the occurrence of paravalvular leakage.
The bioprosthetic leaflets are made from bovine pericardial material, processed through a uniqueAnti-calcification Treatment，Durable usability。
Short stent design with strong radial support, the delivery system is via transapical or transfemoral artery, femoral vein access with atrial septal puncture.
The steerable delivery system can adjust coaxiality during valve deployment., which can effectively solve the problem of valve coaxiality.
Prizvalve® can be used not only for aortic and mitral stenosis but also for the degeneration of bioprosthetic valves in the aortic, mitral, and tricuspid positions.Treatment of Related Heart Valve Diseases。

Among the 120 patients enrolled in the clinical trial, the average age was 74.7 years.Clinical follow-up results at 1 year post-operation showed an all-cause mortality rate of 2.5%., indicating that the application of the Prizvalve valve system canEffectively improve the valve function of patients with severe aortic stenosis and achieve good prognostic outcomes.。One-Year Follow-Up DataFirst Proven Long-term Performance and Stability of the Prizvalve Valve System, which can provide patients with better treatment options.

# Clinical Research

Patient Details

The patient is a 62-year-old male who reports bilateral lower limb edema and shortness of breath for 40 days, following tricuspid valve bioprosthetic replacement surgery 8 years ago.

Echocardiography Indicates: Reduced concentric motion of the biventricular walls, enlarged biatrial and left ventricular chambers, severe tricuspid regurgitation, EF 30%.

The diagnosis result is: Valvular heart disease, moderate to severe tricuspid regurgitation, postoperative tricuspid valve replacement, degeneration of tricuspid bioprosthetic valve, mild mitral regurgitation, arrhythmia, atrial fibrillation, heart failure (NYHA Class IV).

Surgical Plan and Implementation

Due to the patient's advanced age, both the patient and their family refused another surgical operation.Hope to solve the problem through interventional surgery.The patient had a Perimount 29-size bovine pericardial surgical bioprosthetic valve implanted 8 years ago. After an extensive discussion by Professor Sun Yingxian and Professor Guo Liang's team, combined with CT evaluation,Decision to use Prizvalve China-made balloon-expandable valve, planning to implant 29mm valve., Implementation of Transcatheter Tricuspid Valve Replacement (TTVR) After Surgical Bioprosthetic Valve Degeneration.

The patient lies in a supine position. After successful general anesthesia, transesophageal ultrasound is placed, and routine disinfection and draping are performed.Puncture of the right femoral vein under ultrasound guidance as the access routeUsing a catheter and guidewire to perform transvalvular operation on the tricuspid surgical valve, then exchanging to a stiff guidewire into the right pulmonary artery to establish a track. The balloon-expandable valve system is advanced along the stiff guidewire.Successfully complete the system transcatheter。

Precise positioning of the balloon-expandable valve is achieved with the help of the surgical valve imaging frame and the imaging points of the delivery system. Since it is the right heart system, the pressure is inherently below 50mmHg, thus rapid pacing is not required.Slowly inflate the balloon to fully release the valve., and finally complete the valve deployment with the coaxial self-adjustment during the balloon-expandable valve deployment process.

▲Balloon inflation releases the valve.

After deployment, the valve position can be further expanded by re-inflating the balloon. Intraoperative ultrasound showed,No regurgitation in the perivalvular and intravalvular areas.After the surgery, the catheter and guidewire were removed, the sheath was pulled out, and the right femoral vein was sutured with pressure applied to stop bleeding. The patient returned to the CCU after waking up from general anesthesia, and postoperative vital signs were stable.

# Overview of the Balloon-Expandable Valve Track

In terms of the expansion mechanism of heart valves, the mainstream TAVR products currently approved globally are mainly self-expanding (self-expandable valves) and balloon-expandable (balloon-expandable valves).Compared with self-expanding valves, balloon-expandable valves generally have higher radial force.。

In 1999, Edwards Lifesciences internally launched the transcatheter valve program, codenamed "Patriot." In 2004, Edwards Lifesciences successfully acquired PVT, and since then...The commercial era of TAVR balloon-expandable valves has begun.。

From 2007 to 2010,Edward Life Sciences' SAPIEN valve and SAPIEN XT valve, two balloon-expandable TAVR products, have received CE certification in Europe., used to treat patients with heart valve disease who are at high risk for surgical open-heart procedures. In 2014,Edward Life Sciences' Another Groundbreaking Achievement in the TAVR Field—SAPIEN 3 ValveIt obtained CE certification in Europe and received market approval from Japan and the United States in 2016 and 2017, respectively. In 2018, the SAPIEN 3 Ultra valve (an upgraded version of the SAPIEN 3 valve) gained market approval in both the U.S. and Europe.

Subsequently, Edwards Lifesciences launched the ALTERRA stent, which is used in conjunction with the SAPIEN 3 valve to treat patients with severe pulmonary regurgitation. This product received FDA approval for market release in December 2021. The approved product combination also provides a transcatheter treatment option for patients with congenital pulmonary valve disease.

Since the launch of the world's first balloon-expandable valve, the SAPIEN valve, Edwards Lifesciences has continuously optimized its design and improved safety and efficacy. To date, four to five generations of balloon-expandable valves have been approved for marketing. Since 2007,After Edwards Lifesciences' SAPIEN valve and Medtronic's CoreValve obtained CE certification successively, evidence-based medicine began to be carried out in the TAVR field.。

Balloon-expandable TAVR has become one of the main treatment methods in the field of interventional treatment for heart valve diseases internationally.China's First Balloon-Expandable Valve System——Edwards Lifesciences SAPIEN 3 was approved for registration by the National Medical Products Administration (NMPA) in June 2020.With its "advanced balloon-expandable technology" and "low frame, outer skirt design," the SAPIEN 3 valve significantly enhances surgical safety and long-term prognosis for patients.

On December 14, 2022, Shanghai NewMed Medical Co., Ltd. ("NewMed") independently developedPrizballoon® Aortic Valve Balloon Dilation Catheter Approved for Marketing by the National Medical Products Administration (NMPA), this isNewMed Obtains the First Class III Medical Device Product Registration Certificate。It is expected to provide clinicians with a more reliable, integrated solution synchronized with international standards in the near future, combined with the Prizvalve® valve system.

March 2023,Venus MedtechFully Release and Fully Retrieval Dry Valve Product Venus-PowerX Transcatheter Aortic Valve SystemFIM Study Successfully Achieves Primary Endpoint. The all-cause mortality rate at 30 days post-operation was "0," with significant improvement in hemodynamics.The preliminary results demonstrated that Venus-PowerX has the potential to provide a more durable clinical solution with superior paravalvular leak resistance for patients with aortic valve stenosis.

AboutNewMed

Shanghai NewMed Medical Co., Ltd. was established in 2015 as a high-tech medical innovation enterprise with independent intellectual property rights. The company focuses on advanced international standards.Development and Industrialization of Transcatheter Heart Valve Systems。

The company's projects have received support from multiple research and development funds, including the 13th Five-Year Plan project of the National Ministry of Science and Technology and the science and technology support projects of the Shanghai Science and Technology Commission. To date, the companyHas applied for more than 300 patents domestically and internationally, owns 16 products under development, and has 3 products approved to enter the "Green Channel" for special review of innovative medical devices.。

The company focuses on innovative technology research and development, academic promotion, and treatment popularization. It has built a management team that integrates industry, academia, research, and medicine. It has established good cooperative relationships with well-known hospitals and universities in China, developing multiple innovative medical products for cardiac valve interventional treatment, filling the gap in products and technologies in China.