Title：Zhang Ji: Bringing J-Valve valve technology to the world
Attention丨Zhang Ji: Bringing J-Valve valve technology to the world
The 11th G20 Leaders' Summit will be held in Hangzhou, Zhejiang Province in September this year, and technical cooperation and exchange among G20 countries has become an internationally anticipated highlight of the meeting. It is understood that J-Valve heart valve technology in the medical field is expected to be a representative project for technology exchange between China's science and technology sector and G20 countries.
On August 1, in the WeChat circle of friends, Wei Wei, deputy general manager of Suzhou J-valve Medical Technology Co., Ltd. shared a timely message: J-valve Medical's official website is officially online!
A month ago in Beijing, the State Food and Drug Administration organized a special approval meeting for innovative medical devices, 13 top experts in the industry almost "critical" evaluation of the J-Valve valve replacement technology products, which is the "last mile" before the market.
"I have been a cardiac surgeon for nearly 30 years, and it took me 10 years to successfully implement the patented technology, and now it has taken me 6 years to successfully complete the promotion and clinical trials in China." Dr. Zhang Ji, chairman and general manager of Suzhou Jiecheng Medical Technology Co., Ltd. and inventor of J-Valve heart valve technology, said, "Now that this technology has been perfected and matured, it can be widely used in the clinic once the relevant national regulatory authorities approve it for the real benefit of heart valve patients in China and the world."
Blossoming inside the walls
In February 2016, a minimally invasive heart valve replacement was successfully performed for a patient with severe aortic closure insufficiency at St. Paul's Hospital in Vancouver, Canada's largest cardiac surgery center. He was operated on by Canadian medical staff, and the medical device used was "specially approved" from China - Zhang Ji's entrepreneurial research and development team.
The open-heart surgery, which used to take several hours or even more than ten hours, was successfully completed in a very short time without opening the chest and without the heart beating, and the patient regained his life. After the surgery, the patient sat up and ate within 6 hours and was discharged from the hospital in 3 days. Up to now, the hospital follow-up shows that the patient is recovering well.
News of the successful surgery sent shockwaves through the world of cardiac surgery, and Chinese Consul General in Vancouver Liu Fei met with Zhang Ji, "This is the first time that China's independent intellectual property medical technology has entered a developed country." Liu Fei, Chinese Consul General in Vancouver, publicly noted in a media interview.
In 2009, Zhang Ji established Suzhou Jie Cheng Medical Technology Co., Ltd. and settled in Suzhou Wujiang Economic and Technological Development Zone Technology Venture Park.
In August 2010, Dr. Zhang Ji, the inventor of the product, was awarded the "Wujiang Science and Technology Leader" award. In June 2011, Dr. Zhang Ji was selected as one of the "Gusu Innovation and Entrepreneurship Leaders"; In October 2013, Dr. Zhang Ji was selected as one of the tenth batch of "National Thousand Talents Program"; In June 2014, Dr. Zhang Ji was selected as one of the "National Thousand Talents Program". "In June 2014, the company was awarded "Suzhou Science and Technology Small and Medium-sized Enterprises"; in January 2015, Dr. Zhang Ji was awarded "Suzhou Top Ten Charming Technology People".
Compared with the traditional medical technology, J-Valve valve replacement technology product is a "precise movable positioning device heart valve implantation system". This is a minimally invasive surgical technique and product. Compared with traditional heart valve treatment methods, it does not require opening the chest, does not require extracorporeal blood circulation, can significantly reduce the trauma of surgery, shorten the recovery time, reduce patient pain, and reduce the requirements of the patient's physical condition, thus expanding the scope of application, improving the treatment effect, and reducing the cost of surgery, so that most patients who need to replace their heart valves can be treated.
Since early 2014, the J-Valve Valve Replacement System has been in clinical trials at three large and well-known hospitals in China: West China Hospital of Sichuan University, Zhongshan Hospital of Fudan University in Shanghai, and Fu Wai Cardiovascular Hospital of the Chinese Academy of Medical Sciences. To date, more than 100 clinical trials have been successfully completed.
The Chinese clinical cases were published in the Journal of the American College of Cardiology (JACC), the world's leading cardiology research journal where only large, clinically significant studies can be published. This was an important reason why Canada "granted" approval for the first surgery using a medical product from China.
Recognition from experts
"I haven't seen a domestic high-end medical device that is as original as J-Valve." Wei Lai, deputy director of cardiac surgery at Zhongshan Hospital of Fudan University in Shanghai, highly recognized, "This is arguably the most advanced valve disease treatment technology in the world today, and the technical product developed by Zhangji has solved a world-class problem."
In layman's terms, the valve is the door to the heart. Only when the gate opens and closes smoothly and unobstructed can the heart supply blood healthily and effectively; once the valve is narrowed or incompletely closed, the heart will be underpowered and cause heart failure.
Authoritative data shows that heart failure has become the number one cause of death in humans, and heart valve stenosis and insufficiency is one of the most important causes of heart failure. China is a country with a high prevalence of heart valve disease, with more than 2 million patients, and more than 200,000 patients needing surgery each year, but less than 1/3 of patients in China can actually receive surgical treatment.
"This is because of the difficulty and high risk of traditional heart surgery." According to Guo Yingqiang, deputy director of cardiothoracic surgery at West China Hospital of Sichuan University, "There are two methods of traditional heart valve surgery, one is open-heart and the other is extracorporeal circulation."
Guo Yingqiang introduced that open-heart surgery requires a 30-centimeter-long incision below the patient's neck and chest, as well as manual valve replacement by virtue of the doctor's skill, which generally takes up to three to four hours, and the patient needs to endure great trauma and blood loss, as well as a long recovery period after surgery.
"Extracorporeal circulation is the introduction of blood from the whole body into an extracorporeal circulation machine, which replaces the function of the heart. Extracorporeal circulation does not completely mimic heart function and can cause harm to the patient, especially to other organs of the patient, such as the brain, liver, kidneys and lungs," Guo Yingqiang continued to explain, "For patients in their 70s and 80s, due to the decline of multiple organs, and after such extreme non-physiological intervention, it is extremely easy to develop multi-organ complications and even lead to patient death."
J-Valve technology will revolutionize traditional surgery, making it easier to perform and master, simplifying the heart valve replacement process and reducing the demands on the surgeon, relying entirely on the implant system's own positioning device to complete the valve replacement procedure.
The J-Valve system developed by Zhang Ji is the only heart valve system with intelligent three-dimensional positioning, according to Wang Wei, director of the Surgical System Management Committee of Fu Wai Cardiovascular Hospital, Chinese Academy of Medical Sciences, who said that minimally invasive heart valve implantation systems are also being developed in Europe and the United States, but none of them have comprehensive positioning devices.
The J-Valve system is the only heart valve system with intelligent three-dimensional positioning," Zhang explained by analogy. But J-Valve's technology system can be easily operated even by an ordinary heart surgeon. "It's like the old days of professional cameras, where the number of people skilled in them was extremely small; but now with dumb cameras, ordinary people can easily take good pictures."
According to the introduction, there are two manifestations of heart valve disease, one is dominated by stenosis and one is dominated by incomplete closure. Previous minimally invasive heart valve technology products can only be used for patients with stenosis, which requires a "calcified point" as a hard support, while the J-Valve valve does not.
"J-Valve can extend the coverage to the other 50% of patients, and all patients can be covered." Wang Wei told reporters.
"It was a groundbreaking day in the clinical process." Guo Yingqiang recalled that on March 26, 2014, two patients were successfully treated on the first day of the clinic; the first patient was a patient with valve closure insufficiency, and the second patient was a patient with valve stenosis.
To date, West China Hospital of Sichuan University has cumulatively completed clinical procedures on more than 60 patients, "with no case deaths and up to 97% of patients successfully cured." Guo Yingqiang revealed that "other current minimally invasive heart valve techniques are not suitable for closure insufficiency, and although some foreign products have made attempts, overall they are less successful."
Compared to other minimally invasive heart valve technologies, the J-Valve heart valve technology has a very special feature in that it can treat insufficiency. While conventional treatments can only treat stenosis, the J-Valve Heart Valve Technology has a very good feature and function because of its unique design, the split-positioning key - the ability to treat incomplete closure.
Looking forward to an early launch
The relevant experimental report shows that as of the end of July 2015, J-Valve technology has successfully completed the established number of clinical trials, proving that J-Valve is far superior to existing interventional valves at home and abroad, while overcoming the world problem that traditional interventional valve technology cannot treat simple aortic valve insufficiency; breaking the situation that minimally invasive heart valve replacement surgery is completely monopolized by foreign products.
At present, J-Valve technology has initially formed a new treatment standard in the field of valve surgery in China. According to clinical practice, aortic valve replacement with J-Valve technology takes only 7-10 minutes. It is worth mentioning that the clinical trial subjects were all high-risk, elderly patients with an average age of 74 years or more and a maximum age of 87 years.
"I received an Email from the former president of the International Society for Minimally Invasive Cardiothoracic Surgery, who said that he congratulated us on a new breakthrough in this field." Wei Lai told reporters that after the article was published, the world's top experts in cardiac surgery called and emailed to congratulate the Chinese research team.
"Minimally invasive valve technology has mostly been used abroad before. the success of the J-Valve clinical trial marks that China has caught up in this field and is on par with the international scene." Wang Chunsheng, director of cardiac surgery at Zhongshan Hospital of Fudan University in Shanghai, commented, "Previously, we were waiting for others to use it before introducing it. Now it is we have completely independent intellectual property rights, and it has been completely recognized by international counterparts."
According to the report, the U.S. FDA has specifically allowed the J-Valve valve to enter pivotal clinical trials directly in the United States without first going through preliminary feasibility clinical trials. Similarly, Health Canada (Health Canada) approved the J-Valve Valve Replacement System as a humane medical device for the life-saving treatment of aortic valve patients.
"We have closely followed up on more than 40 patients who underwent clinical trial surgery at Zhongshan Hospital, with the first case in May 2014 and the latest one being six months old," Wei said, "We were originally concerned that the new valve would shift after a period of use and other problems that the patient would need a secondary intervention, which has not occurred so far."
"In the case of strict procedures, the country should properly speed up the approval process, now that the clinical trial has ended, many patients hope that the technology can be promoted and used one day earlier," appealed a domestic tertiary hospital director who did not want to be named, "I can only tell patients now to wait patiently for another I can only tell patients now to be patient and wait a little longer, and this product will be officially approved soon."
"We expect to popularize heart valve replacement surgery in the future as a simple outpatient procedure that can be done in county hospitals," said Wei Wei, the company's vice president, who has just become a medical expert, "We expect the current production capacity to be 10,000 sets a year, and after the product is officially launched, we will first push the product to the Chinese market and further to the international market, for the benefit of the world's majority of heart valve patients."
"At the end of June, the State Food and Drug Administration commissioned the Jiangsu side to carry out the inspection and acceptance," Gu Hua, deputy director of the Science and Technology Bureau of Wujiang Economic and Technological Development Zone, told Minsheng Weekly, "Our development zone has also reserved a piece of land for the company in case it needs to expand its operation in the future. "