Privately held, commercial-stage medical device company IlluminOss Medical has launched the IlluminOss bone stabilization system in the US for use in the treatment of traumatic and fragility fractures.
Image: IlluminOss Medical launches IlluminOssÒ. Photo: Courtesy of stockdevil/FreeDigitalPhotos.net.
The IlluminOss bone stabilization system can be used in skeletally mature patients in the treatment of traumatic and fragility fractures of the humerus, radius and ulna.
IlluminOss recently secured approval from the US Food and Drug Administration (FDA) for its bone stabilization system, which was previously used solely for treating pathological and impending pathological fractures associated with metastatic disease in the US.
IlluminOss stated that the new product uses an expandable balloon implant that is delivered in a minimally invasive manner through a small incision to support poor quality, compromised bone. When the implant is infused with a monomer, it will conform to the shape of the patient’s intramedullary bone canal.
A visible blue light will cure the implant rapidly and immediately stabilizes the fracture. IlluminOss claims that the use of the new system results in reduced hospital stays, shorter procedure times, less post-operative pain, less use of pain medications and patients returning to their daily living activities faster.
IlluminOss Medical CEO Jeff Bailey said: “We are thrilled to announce the commercial launch of the IlluminOss System. IlluminOss is truly an innovative addition to fragility fracture treatment and we have been receiving outstanding feedback from our orthopedic surgeon customers regarding its potential to make a difference for patients with poor quality bone. Entry into the multi-billion dollar U.S. trauma market marks a significant milestone for our company.”
The IlluminOss System secured its initial de novo FDA clearance in December 2017 for fractures associated with metastatic bone. The clearance for traumatic and fragility fractures was received last August.
The system has been commercially available in international markets and has been in clinical use since 2010.
Last September, the company received additional clinical clearance from FDA for using the bone stabilization system in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius and ulna.