Venus Medtech | Top Cardiovascular Solution Company 2023

MedTech Outlook Magazine

Venus Medtech
Treating Structural Heart Diseases with Technical Innovation

Eric Zi, Co-founder and CEO, Venus MedtechEric Zi, Co-founder and CEO
Transcatheter valve replacements are the most viable treatment option for structural heart diseases.

Venus Medtech, a global leader in transcatheter therapy products is dedicated to developing and commercializing revolutionary medical devices for patients.

“We own over 800 patents and patent applications and more than 500 issued patents, with 300 of them being authorized invention patents and over 20 PCT international applications,” says Eric Zi, Co-founder and CEO of Venus Medtech.

Venus Medtech’s specialty in transcatheter valve replacements stems from the current situation in its home country. More than 18.9 percent of the population in China is over 60 years old, and there is an increasing demand for effective structural heart disease treatments. The team at Venus leverages its goldmine of knowledge gathered from years of experience in the MedTech sector to address this situation.

It offers comprehensive solutions for all four heart valves– TAVR, TPVR, TMVR, and TTVR.

One of its most notable achievements is a transcatheter pulmonic valve replacement device (TPVR), the VenusP-Valve, created by a talented team of engineers.

In 2019, VenusP-Valve was included by the Chinese National Medical Products Administration (NMPA) in the “Special Review and Approval Procedures for Innovative Medical Devices” In April 2022, TPVR became the first Class-III implantable cardiovascular device to receive a CE marking under the Medical Devices Regulation (MDR) in Europe.

Following its CE MDR approval, VenusP-Valve was approved by China’s NMPA in July 2022, making it the first self-expanding TPVR product approved for marketing in both China and Europe. With clinical data from Europe and China backing up its long-term safety and efficacy, VenusP-Valve has received high recognition from the international medical community.
Interventional treatments of mitral and tricuspid regurgitation have been regarded as technically difficult globally. Cardiovalve system stands as one of the best devices for interventional replacement product for patients suffering from mitral or tricuspid regurgitation. Behind this device there is a great team, and the original concept goes back almost ten years.

In January 2020, Cardiovalve received ‘Breakthrough Device Designation’ by the FDA for the treatment of tricuspid regurgitation. And its Target CE confirmatory clinical trial for tricuspid regurgitation was initiated in Nov. 2022 and has enrolled over 20 patients by April, 2023. Its treatment of mitral regurgitation has entered clinical trials in Europe and is currently undergoing early feasibility study in the U.S. A number of well-noted international cardiovascular centers were widely involved in its clinical trials.

Venus Medtech’s next-generation dry-tissue valve, Venus-Vitae and Venus-PowerX is a real game changer for TAVR. Leveraging the unique Venus-Endura tissue, the valve provides enhanced anti-calcification and hemodynamic effects, which in turn improves valve durability. In addition, the dry-tissue valve can be premounted and contains no aldehyde residue, thereby enhancing safety while facilitating clinical use and valve storage and transport. Notably, empowered with intelligent active anti-paravalvular leak (anti-PVL) technology, the devices are able to provide an effective anti-PVL solution for patients.

  • We own over 800 patents and patent applications and more than 500 issued patents, with 300 of them being authorized invention patents and over 20 PCT international applications


The Medtech R&D process is long and filled with tedious trialand- error stages. Staying innovative without sacrificing efficiency during these processes is key.

Venus Medtech leverages its relationships with industry experts leading in medical innovation from around the world, including Israel, the U.S, and Europe, to optimize its R&D process. It applies the combined knowledge and skills of these experts to fast-track the R&D process, and meet deadlines and goals without sacrificing quality and innovation. At the same time, its marketing prowess plays a significant role in bringing the devices and products to hospitals and medical institutions in record time. Venus Medtech provides training on the VenusP-Valve to physicians worldwide to ensure there are no complications during insertion.

Venus Medtech’s success in the structural heart disease field cannot be understated. It established the Venus Global Heart Valve Innovation Center in Israel to grow its global footprint and advance product innovation through the skills and knowledge of the country’s top minds.

Apart from engineering modern heart valves, its team also manufactures devices for hypertrophic cardiomyopathy, hypertensive renal denervation therapy, and relevant accessories.

A torchbearer of innovation and advancements in the medical field, Venus Medtech aims to consistently deliver nothing less than robust and revolutionary products. Committed to the development and commercialization of innovative medical devices, it plans to continue transforming the way structural heart diseases are treated worldwide.

Top 10 Cardiovascular Solution Companies - 2023

Company
Venus Medtech

Management
Eric Zi, Co-founder and CEO

Description
A global leader in transcatheter structural heart therapies, Venus Medtech is a China-based MedTech company dedicated to developing and commercializing innovative and revolutionary medical devices for patients with structural heart diseases.

Venus Medtech News

Venus Medtech VenusP-Valve transcatheter pulmonic valve replacement system granted Health Canada approval

HANGZHOU - Venus Medtech (02500. HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that, VenusP-Valve, the company's in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, cleared approval from Health Canada.
As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.
"VenusP-Valve is able to eliminate pulmonary regurgitation in a wide range of anatomies," said Prof. Lee Benson, Director of Cardiac Diagnostic and Interventional Unit at the Hospital for Sick Children in Toronto, Canada. "Available in different sizes and specifications, the product offers extensive applicability to meet the clinical needs of a larger pulmonary regurgitation patient population."
Clinical data reveals that VenusP-Valve demonstrates safety and efficacy on par with similar products, and excels in aspects such as rates of reintervention and arrhythmia. According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve is 100%. All-cause mortality and reintervention rates were zero. In addition, no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects. The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients' cardiac function.
As the company's international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022, becoming the first Class III implantable cardiovascular device approved under the new MDR. In 2023, after receiving Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA), VenusP-Valve gained its first ethical approval in the territory, setting the stage for the VenusP-Valve PROTEUS pivotal clinical trial. More recently, the U.S. Centers for Medicare & Medicaid Services (CMS) also granted coverage approval for the PROTEUS study.
"Seeking effective treatments for major diseases that pose a serious threat to human health is what we do at Venus Medtech, which makes us proud to have received this Health Canada approval,'' said Lim Hou-Sen, Chief Executive Officer of Venus Medtech. "The approval of VenusP-Valve represents a meaningful expansion of clinical options for patients in the country."
Following its first clinical implantation in 2013 by Academician Ge Junbo, Director of Cardiology at Zhongshan Hospital, Fudan University, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, and Spain, with its implantation seeing continuous growth in new hospitals and centers.