Trice Medical breaks surgical boundaries with the world's first FDA-cleared single-use 25° needle arthroscope - giving surgeons the tools they need to see more pathology
The Trice Medical 25-degree mi-eye 3 needlescope™ with one-of-a-kind horizon leveling technology has received FDA 510(k) Clearance, clearing the way for surgeons to improve minimally invasive outcomes for patients in care settings in or out of the operating room. The single-use, fully integrated percutaneous device provides unparalleled maneuverability and expanded views into small joints that are inaccessible to other disposable or even reusable arthroscopes currently available in the market.
MALVERN, Pa., Oct. 26, 2021 /PRNewswire-PRWeb/ -- Trice Medical has received FDA 510(k) Clearance for 25-degree mi-eye 3 needlescope™ with distinctive horizon leveling technology, clearing the way for unparalleled views and maneuverability in arthroscopic and endoscopic procedures from a single-use, single-hand device. Used with the proprietary high-resolution mi-tablet™ 3, the technology takes minimally invasive operative and diagnostic capabilities in small joints and patient outcomes to a new level.
"The 25-degree mi-eye 3 needlescope™ is a huge win for medicine. It allows physicians to expand the field of view and access areas of joints as no arthroscope has done before," said Mark Foster, President and CEO of Trice Medical. "For decades, using an angled camera over a 0-degree camera has been the standard of care in arthroscopy. No physician would ever use a 0-degree reusable arthroscope in the operating room and now they don't have to take a step back in quality just to use a disposable camera either. Our early data shows the potential to see over 16x more information with our angled camera vs. a 0-degree camera. This is another in a long list of worlds' first innovations from Trice Medical."
"I can clearly see all aspects of the joint space and visualize areas that are difficult to see with a traditional arthroscope," said Richard Ferkel, M.D., Orthopedic Surgeon and Director of the Sports Medicine Fellowship of Southern California Orthopedic Institute. "This 25-degree camera is easy to maneuver all over the ankle and other small joints, and the image quality is comparable to reusable operating room equipment."
The 25-degree mi-eye 3 needlescope™ and the high-resolution mi-tablet™ 3 platform integrates the latest technology with 8-in-1 capabilities: image horizon leveling, high-resolution image sensor, integrated camera with LED illumination, single-hand operation, image management, seamless workflow with hospital information management systems, the ability to manipulate the viewing angle with horizon preferences, and portability.
"The 25-degree scope allows me to visualize a joint as I would with a traditional arthroscope at a fraction of the size. This landmark advancement enables me to perform surgery the way I've been trained, while enabling me to provide the patient with the expected excellent outcome in a more minimally invasive way. No other needle arthroscope on the market affords me that treatment option," said Sean McMillan, D.O., Sports Medicine Orthopedic Surgeon.
The new mi-eye 3 needlescope™ camera performs the same as a reusable but in a small disposable form. Its streamlined design eliminates undesirable aspects of existing reusable arthroscopes, including the two-handed light source and angle rotation requirements and multiple accident-prone cables. It also removes costly equipment, sterile processing, and other expenses.
Trice Medical is excited to provide surgeons and facilities access to this game-changing technology. The company recently received a strategic investment from Bioventus (Nasdaq: BVS), a global leader in innovations for active healing, advancing the sale and distribution of Trice products outside of the US.
About Trice Medical:
Trice Medical, headquartered in Malvern, PA, is a global leader in medical technologies with the purpose of building a great company that enhances quality of life. The company offers minimally invasive and portable solutions for diagnosing and treating distal extremities that can be performed in any care setting: the operating room, a procedure room, or the office. Trice Medical's portfolio includes mi-eye™ High-Resolution Imaging Platform; mi-ultra™; Seg-WAY™ Endoscopic Release Systems; and Tenex Health TX® for treating chronic tendinopathy and bony prominences, including diabetic foot ulcers. More information is available at http://www.tricemedical.com.
Media Contact
Lyly Hoang Wight, Sr. Director, Global Marketing, Trice Medical, +1 (610) 989-8080, [email protected]
SOURCE Trice Medical
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