First Successful Vertebral Reconstruction Surgery in Taiwan with Taiwan-Made Device

News on June 17, 2019

According to the National Health Insurance, one in every four people over the age of 65 in Taiwan has a vertebral compression fracture due to osteoporosis. “Vertebral body augmentation system” is a category of surgical procedures for "vertebral reconstruction” for compression fractures, which expands the vertebral body vertically for bone cement injection to stabilize fractured vertebra with the goal of alleviating the patient’s long-term pain. The "vertebral body augmentation system" is a permanent implant medical device with a very high technical threshold. It requires multiple precision metal processing procedures and must be integrally formed with high quality requirement. Taiwan Instrument Research Institute (TIRI), of National Applied Research Laboratories (NARLabs) assists Wiltrom Medical Co. successfully developing “Tripod-Fix” Vertebral Body Augmentation System (MOHW-MD-No.006305). China Medical University Hsinchu Hospital took the lead in adopting the first Taiwan-made vertebral augmentation system for vertebral reconstruction surgery. The patient recovered well and was able to move freely and go home after an overnight hospital stay.

Taiwan independent research and development and manufacturing + TIRI/NARLabs assistance

As aging population boosts, demand for orthopedic care has also increased. According to global market research institutes, TrendForce and Research and Markets, the global medical device market is estimated to reach US$444.2 billion in 2018 and US$577.6 billion in 2023. The global market for vertebral reconstruction is estimated to be US$4.8 billion in 2026 and continues to climb at an annual growth rate of 8.25%, making it the most significant and highly developed industry in all spine surgery.

At present, the vertebral body augmentation system on Taiwan market are all imported brands. The mechanical principle of vertebral body augmentation system is similar to car jack. After placing the jack into the vertebral body, the collapsed vertebral body is expanded in a vertical manner for bone cement injection to achieve the effect of stabilizing fractured vertebra and long-term pain relief.

General Manager of Wiltrom, Huang-Chien Liang, pointed out that compared with other foreign brands, Wiltrom’s vertebral body augmentation successfully applies multifaceted propulsion power and is the first system to support in 3D for patient better recovery and reduce pain and discomfort. At the same time, Wiltrom’s vertebral body augmentation system is the only security mechanism on the market with a retractable design, which can effectively reduce the surgery risk and improve the competitive advantage in the global market.  

Wiltrom’s products are 100% independent R&D and manufactured in Taiwan, so product quality can be fully controlled. However, in addition to technology and quality, Dr. Huang-Chien Liang, expressed that it is more important that "with the assistance of the ‘TIRI/NARLabs’ Medical Device Accelerator Project’, the risk of product development is greatly reduced, and novel medical device product can be successfully launched." This new vertebral body augmentation aims to create a market value of more than NT$500 million within three years and provide domestic and foreign medical institutions the opportunity to use Taiwan's high-quality innovative medical device products and benefit more patients.


Better care for patient, China Medical University Hsinchu Hospital first adopting new innovative medical device

Mrs. Liu, 80-year-old, fell at home at the end of April this year. She was admitted to the hospital for emergency treatment because of severe back pain. She was found to have compression fractures in the third segment of the lumbar spine after X-ray in Chinese Medicine University Hsinchu Hospital. After further MRI scan, it was confirmed that surgery should be arranged. In order to provide better vertebral collapse improvement effect, doctor decided to adopt a new Taiwan-made vertebral body augmentation system which is supported in 3D with multifaceted propulsion power and features vertebral collapse reset design. Dr. Hsiang Ming Huang, director of the Department of Neurosurgery, said that Mrs. Liu recovered well after surgery on May 8 and she left the hospital after one night stay and moved freely. Her current condition is good and the back pain has relieved significantly.

Dean of the China Medical University Hsinchu Hospital, Dr. Tzu-Liang Chen, pointed out that providing intimate medical services and quality medical resources to Hsinchu is the original intention of the establishment of China Medical University Hsinchu Hospital. In order to provide a patient-friendly treatment environment, China Medical University Hsinchu Hospital cautiously reviews hardware environment and surgical evaluation with the prudent attitude of "taking patients as the respect and taking the hospital as the pride", to offer highest quality medical services to patients. In addition, they are also willing to contribute to create innovative medical environment with TIRI/NARLabs.

China Medical University Hsinchu Hospital and TIRI/NARLabs expect more manufacturers joining the industry-research-medical cooperation model in the future. Networking new innovative devices with “TIRI/NARLabs’ Medical Device Accelerator Project”, manufacturers can accelerate the progress of commercialization to provide better care quality for clinical needs and also promote Taiwan's medical brands to the world stage.

Industry-research-medical cooperation to promote Taiwan high-end medical device brands

Due to high technology requirement, most of vertebral body augmentation systems are mainly from European and American manufacturers. With the assistance of TIRI/NARLabs and China Medical University Hsinchu Hospital, Wiltrom has become the first medical device manufacturer approved by Taiwan TFDA. As a new startup company, Wiltrom has obtained the technical energy of prototyping, surgical instrument testing, surgical simulation and medical imaging under the guidance of the “TIRI/NARLabs’ Medical Device Accelerator Project", and then pass the evaluations and is able to compete with foreign brands for the international market. “Inheritance Ceremony for First Successful Vertebral Reconstruction Surgery with Taiwan Made Device” was held on June 17 in China Medical University Hsinchu Hospital to witness the hospital’s excellent medical service quality and also demonstrate the specific contribution made by “TIRI/NARLabs’ Medical Device Accelerator Program” to Taiwan medical device industry. Through the alliance cooperation with China Medical University Hsinchu Hospital, aim to create a flourishing prosperity of the Hsinchu biomedical industry. 

Deputy Minister of Ministry of Science and Technology (MOST), Dr. Dar-Bin Shieh, said in his speech during the ceremony that the biomedical industry is one of government’s key development industries. MOST is fully confident with Taiwan innovation energy and actively assists Taiwan's new teams to integrate resources at home and abroad. Wiltrom, based in Hsinchu Biomedical Park, is one of them. MOST hopes to strengthen the cluster effect of the medical device industry and accelerate the commercialization of research and development results through the mutual chain of Taiwan new startup teams.  

Dr. Kuang-Chong Wu, Vice President of NARLabs, pointed out that NARLabs has built up an integrated biomedical technology and development service platform, systematically linking innovative energy to the industry, to strengthen Taiwan's biomedical industry development and accelerate the advancement into the international market. Dr. Yao-Joe Yang, Director General of TIRI, stressed that TIRI owns a unique secret weapon, “one-stop medical device accelerator”, to assist the newly start-up teams with special experts, special projects and professional counseling to increase the medical device value and innovation, and more importantly, to significantly reduce the research and development costs and risks and increase the success rate.  

Tung-Cheng Yin, Director General of Public Health Bureau of Hsinchu County said that biomedical technology is an important piece for Hsinchu County Cultural Science and Technology Smart City development blueprint jigsaw, and is also a key factor for another 30-year new prosperity of Hsinchu County. Both Hsinchu Biomedical Park and China Medical University Hsinchu Hospital are located in Chubei City, Hsinchu County, and benefit Hsinchu County citizens a lot. It is believed that through the cooperative efforts of MOST, NARLabs, manufacturers and the Hsinchu County Government, the biomedical industry cluster effect will happen to create economic benefits and promote vigorous development of Hsinchu County.