Ostania aktualizacja 4 December 2019
The National Institute of Health and Clinical Excellence in the UK maintains its previous recommendation on the EXOGEN® ultrasound bone healing system
HOOFDDORP, The Netherlands – Bioventus, a world leader in orthobiological solutions, received a notification from the National Institute of Health and Clinical Excellence (NICE) in the United Kingdom that it updated its guidelines (MTG12) regarding the use of the EXOGEN ultrasound bone healing system to treat long bone fractures without union. EXOGEN uses low-intensity pulsed ultrasound (LIPUS) to stimulate the natural bone healing process and promote fracture healing. 1 It also has 86% healing rate for fractures that do not heal themselves 2 and provides 38% faster treatment for new fractures. 3.4
NICE reviewed a large amount of clinical evidence and based on the findings of its external assessment center (EAC), will maintain the recommended use of EXOGEN specific for the treatment of non-union long bone fractures, which NICE defines as fractures that do not heal after nine months.
In addition, EAC reviewed and updated the cost parameters in its original cost modeling and found that although the cost of the revision surgery increased by 25%, the costs associated with the use of EXOGEN in the treatment of long union fractures remained the same because the last published review in 2013 resulted in this doubles the cost savings to GBP 2,407 (formerly GBP 1,164) per patient, compared to current care management, by avoiding surgery.
“EXOGEN has for many years been a proven alternative for patients who want to treat fractures of long bone adhesions and avoid surgery,” said Tony Bihl, CEO, Bioventus. “These updated guidelines from NICE are a continuation of previous recommendations for use and highlight the cost savings achieved by patients suffering from adhesions, which provides significant economic relief for the UK healthcare system.”
“EXOGEN is also a proven supportive therapy for surgically treated fractures and has many level 1 studies that show its positive effect on fracture healing,” said Peter Shaw, MBBS DRCOG, medical director at Bioventus. “Both the updated clinical and economic evidence presented in this revised MTG12 Guide definitely supports the decision of clinicians to prescribe EXOGEN and, most importantly, provides positive results for patients.”
Bioventus is an orthobiological company that provides clinically proven, cost-effective products that help people heal quickly and safely. His mission is to make a difference, helping patients resume and enjoy an active life. Orthobiological products from Bioventus include offers for osteoarthritis, surgical and non-surgical bone healing. Based on compliance with high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for doctors around the world. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.
Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC.
EXOGEN is indicated for the non-invasive treatment of bone defects (except vertebrae and skull), which includes treatment of delayed adhesions, adhesions, * stress fractures and joint anastomosis. EXOGEN is also indicated to accelerate the healing time of a fresh fracture, repair after osteotomy, repair bone transport procedures and repair distraction osteogenesis. There are no known contraindications for EXOGEN. Safety and efficacy have not been established for persons without bone maturity, pregnant or breastfeeding women, patients with pacemakers, fractures caused by bone cancer or patients with poor blood circulation or coagulation problems. Some patients may be sensitive to ultrasonic gel. Full prescription information can be found on the product label at exogen.com or by calling Bioventus customer service on 0800 05 16 384 (UK) / 1800 552 197 (IR).
* It is considered that the connection has not been established when the fracture site does not show any apparent signs of healing.
1. Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low intensity pulsed ultrasounds accelerate the healing of rat femur fractures by acting on various cellular reactions at callus fractures. J Bone Miner Res. 2001; 16 (4): 671–680.
2. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH Low intensity pulsed ultrasound in the treatment of non-compounds. J Trauma. 2001; 51 (4): 693–703.
3. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF Acceleration of healing of tibia fractures by low-intensity non-invasive pulsed ultrasound. J Bone stroke [Am]. 1994; 76 (1): 26–34.
4. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR Accelerated healing of distal radial fractures using special low-intensity ultrasounds. A multicentre, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg [Am]. 1997; 79 (7): 961–973.