OrthoDynamix' ArthroSteer 3.5mm Ablator for general surgical use receives FDA clearance

NewsGuard 100/100 Score

OrthoDynamix announced today that it has received FDA clearance for its new device, ArthroSteer 3.5mm Ablator, a mono polar electrosurgical device, for general surgical use, including the orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulating soft tissue in, but not limited to the knee, shoulder, and primarily the hip.

Approximately 40 million Americans are affected by joint pain due to multifactorial causes.  There are over 1 million annual surgical interventions of the knee with over 300,000 shoulder and hip procedures.

ArthroSteer's patent pending technology improves triangulation and or orientation of its instruments in tight joint capsules enabling the surgeon greater access to damaged tissue.  The 3.5mm and/or its 5mm high dexterity instruments have surgeon controlled 180 degree bend of the distal shaft while the tip can rotate 360 degrees on its axis, independent of the shaft.

"ArthroSteer's 3.5mm Ablator FDA clearance is an important step for increased sales opportunity in the US," said Bill Dennis, CEO of OrthoDynamix.  "This product complements our unique sports medicine portfolio of steerable ArthroSteer Punch, Grasper and Biter that are currently marketed in the US.  This product portfolio is also being readied for the global market upon receipt of their CE mark."

Advanced and differentiated products for sports medicine, the ArthroSteer's 3.5mm Ablator is designed to withstand the rigors of arthroscopy.  It is also designed for cost savings since it interfaces with many of the hospital's current mono polar electrosurgical generators, thus additional capital equipment is not required.  

Source:

OrthoDynamix LLC

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Renaissance of "food as medicine" in modern clinical trials