Medical Device News Magazine

Bioventus Updates Indications for Use of Their EXOGEN Ultrasound Bone Healing System

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

Summation

  • In addition, EXOGEN will heal fractures in the presence of infection at the fracture site and also serve as an important adjunctive therapy when stabilizing fractures with instrumented fixation.

Bioventus has updated the indications for use for its EXOGEN Ultrasound Bone Healing System. EXOGEN uses process and promote fracture healing. It has an 86% heal rate for fractures not healing on their own1 and provides 38% faster healing of indicated fresh fractures.2, 3

The updated label now prominently features indications for using EXOGEN as an adjunctive non-invasive treatment of established nonunions in patients:

  • With internal or external fracture fixation hardware present
  • Undergoing treatment for infection at the fracture site
  • Believed to have diminished bone quality

“This label update underscores important usage scenarios where fracture management protocol may have limited consideration. Now, EXOGEN may be confidently prescribed in these indications,” said Peter Shaw, MBBS DRCOG, Chief Medical Officer, Bioventus. “Patients with comorbidities such as osteoporosis and bone infection can benefit from use of EXOGEN by helping to progress fracture healing and resolve nonunion. In addition, EXOGEN will heal fractures in the presence of infection at the fracture site and also serve as an important adjunctive therapy when stabilizing fractures with instrumented fixation.”

Summary of Indications for Use

EXOGEN is indicated for the non-invasive treatment of established nonunions† excluding skull and vertebra. The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions† in patients:

o With internal or external fracture fixation hardware present. EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware.

o Undergoing treatment for infection at the fracture site. EXOGEN is not intended to treat the infection.

o Believed to have diminished bone quality. EXOGEN is not intended to treat diminished bone quality.

EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures. There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling at exogen.com or by calling Bioventus Customer Service at 800-836- 4080.


References

† A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

1. Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH Low-intensity pulsed ultrasound in the treatment of non- unions. J Trauma. 2001; 51(4):693−703.
2. Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surge [Am].1994; 76(1):26−34.

3. Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR Accelerated healing of distal radial fractures with the use of specific, low- intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg [Am]. 1997; 79(7):961−973.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease

The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.

Ultrahuman Announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals.

VisionAir Solutions Celebrates Milestone and New Collaboration

This achievement marks VisionAir Solutions commitment to bringing technological innovation to pulmonary medicine. Since its acquisition by Theken Companies last year, VAS has over doubled its growth and continues to demonstrate industry adoption and the advantages of personalized healthcare.