Shanghai, China —The Bipolar Easy™ Hemiarthroplasty System (Bipolar Easy™), a proprietary product developed and produced by Suzhou MicroPort® OrthoRecon Co., Ltd., a subsidiary of MPO China , recently received the registration certificate issued by the National Medical Products Administration (NMPA), making it the first domestic hemiarthroplasty system by MPO China to receive marketing approval.
Osteoporosis has become one of the major causes of fractures in the elderly population. With the accelerated aging of the Chinese population, the number of elderly patients with femoral neck fracture and partial femoral intertrochanteric fractures is expected to increase in the future. For those elderly patients with few daily activities, normal body mass index (BMI) and no severe wear or deformation of acetabular cartilage, it is possible to relieve the pain and improve the quality of life through hemiarthroplasty surgery, or artificial femoral head replacement.
Featuring a bipolar design, Bipolar Easy™ can more effectively reduce the incidence of post-operative joint pain and allow for greater range of motion for patients, as compared with using systems with unipolar hemiarthroplasty design. It is designed with a simple one-piece cup-and-liner system and bipolar locking device, allowing for shorter surgery time, less intraoperative bleeding, and increased postoperative stability. The liner is made of highly crosslinked UHMWPE, which minimizes wear, improves the service life of the prosthesis and reduces the incidence of postoperative complications.
Zixin Weng, President of MPO China, said, “Following the launch of domestic total knee replacement systems SoSuperior® and Aspiration™ last year and Goral™ Total Hip Arthroplasty System this year, the recent marketing approval of Bipolar Easy™ Hemiarthroplasty Bipolar System marks the completion of the domestic primary arthroplasty product line of MPO China. In the future, we will continue to perfect the domestic arthroplasty product line of MPO China and remain committed to the research, development and promotion of new orthopedic technologies, concepts and products to provide more high-quality medical solutions for patients and doctors.”
Repeated testing at high intensity and frequency has shown that Bipolar Easy™ provides the equivalent stability and strength as similar mainstream products, while achieving greater patient range of motion and increased postoperative satisfaction of patient. In addition, the system adopts a size configuration of 38-54mm with 1mm increment, which is more compatible with clinical needs of Chinese patients, especially those with small skeletal morphology, and provides doctors with more diversified options to better match their surgical plan.
The system is compatible with the Goral™ Total Hip Arthroplasty System independently developed and manufactured by MPO China, and it completes and supplements the line of domestic primary hip arthroplasty systems to meet the clinical needs of elderly patients with femoral neck fracture. Both systems can be combined with SuperPATH®, an exclusive supercapsular percutaneously assisted total hip arthroplasty procedure by MicroPort® Orthopedics. As the world’s first fast recovery procedure of the kind, SuperPATH® uses incisions measuring 6-8 centimeters to perform hip replacement.