Safety and Efficacy of New Class of Orthopedic Implant for Intramedullary Biologic Stabilization of Fractured Long Bones Studied Out to 1 Year

This Week’s News in Review

This Week's News in Review! Medical Device News Magazine keeps our readers up-to-date on breaking industry news! Learn how Medical Device News Magazine can help...

New Research Shows Nearly Half of Elderly Suffer Decreased Mobility During Lockdown

In a survey of UK adults with parents over the age of 75, while over half (52%) of respondents remain worried about their parents catching Covid, 48 percent are concerned about parental loneliness, and 46 percent about their parents falling alone and not being able to get up or get help. This figure remained high even among those whose parents are in care homes, with 37% of respondents still most concerned about parents falling over.

American College of Cardiology Names Ravee Kurian COO/CFO

Kurian comes to ACC following a 20-year stint at Publicis Sapient, a leading technology and communications consultancy, where he led critical and sensitive digital transformation initiatives for Fortune 500 and U.S. federal clients.

CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, announced today it has published safety and efficacy data at one year showing that percutaneous intramedullary fixation can provide for stabilization of bone fractures while avoiding the need for open surgery. Results of this study have been published in the Journal of Orthopaedic Research.

“Our study further evaluates the percutaneous application of the IlluminOss System, which is a light-curable photodynamic bone stabilization device developed by IlluminOss Medical as a safe and biocompatible treatment for fracture stabilization and repair in load-bearing bones, such as the long bones of the leg,” said co-investigator Brett G. Zani, Ph.D., Director of Applied Sciences, CBSET.

“Local biocompatibility evaluations comparing the IlluminOss System to standard K-wire implants showed no significant long-term local tissue reactions associated with either implant, and good systemic biocompatibility of the IlluminOss System over the course of a year,” added co-investigator and CBSET scientist Amanda L. McSweeney.

The IlluminOss System is commercially available in international markets under a CE Mark for approved clinical applications through both a direct sales force and distribution networks. It combines the use of proven medical polymers and traditional balloon catheter technology to provide a completely new technology for patient-specific, percutaneous orthopedic implants. The implant begins as a liquid monomer that is completely contained within a Dacron or PET balloon. Once inside a patient’s bone, it conforms to the geometry of that patient’s intramedullary canal, whereas traditional rigid intramedullary rods have only small discrete contact points. Now, international surgeons have the option to use the IlluminOss product alone or in conjunction with traditional hardware and screws for multiple types of fractures.

“CBSET’s high-quality preclinical evaluation continues to substantiate the application of our bone stabilization system and its potential to be a truly disruptive alternative to traditional fracture repair,” said Robert Rabiner, Chief Technical Officer & Founder of IlluminOss Medical.

“CBSET strives to help innovative companies such as IlluminOss to develop new and disruptive technologies that foster paradigm-shifting improvements in patient care. In this case, for patients requiring fracture-fixation in an orthopedic trauma care unit, access to a new solution that is metal-free and can be performed in a minimally invasive manner, and not open surgery, is exciting, and our organization is proud to have contributed,” said Peter Markham, President, CEO and a co-founder of CBSET.

To learn more about these results and the services provided by CBSET, please contact: Michael Naimark, Director, Business Development: +1-970-988-5273, mnaimark@cbset.org.

* The IluminOss™ System is approved for sale in Europe and for investigational use in the U.S.

spot_img

DON'T MISS

Dr Jonathan Slotkin Appointed to Peer Well Board of Directors

Alongside the appointment, PeerWell is launching its new clinical practice, PeerWell Health.

Zimmer Biomet Announces New Appointments to Executive Leadership Team

Wilfred van Zuilen Appointed as President of Europe, Middle East and Africa. Nitin Goyal, M.D. Appointed to Newly Created Role of Chief Science, Technology and Innovation Officer.

Subscribe to Medical Device News Magazine here.

Related Articles