Home Medizin Der selbsthaltende chirurgische Retraktor Galaxy II® von JUNE Medical erhält die MDR-Zertifizierung für seine hohe Qualität und Sicherheit

Der selbsthaltende chirurgische Retraktor Galaxy II® von JUNE Medical erhält die MDR-Zertifizierung für seine hohe Qualität und Sicherheit

von NFI Redaktion

JUNE Medical is proud to announce that its Galaxy II® self-retaining surgical retractor has received certification under the Medical Devices Regulation (MDR – Regulation (EU) 2017/745) for use in the European Union from the BSI Group. This accreditation is evidence of the value that this innovative self-retaining retractor offers in improving patient safety and overall quality of healthcare in all surgical specialties, including ENT, pediatrics, dentistry, vascular surgery, and many more.

The groundbreaking Galaxy II retractor’s self-retaining cam locking system enhances comfort, quality, and ease of wound visualization in medical practices by allowing one-handed adjustments and eliminating the dependence on OR assistants, optimizing staff time and patient safety. The latest addition to the product line, the Galaxy II Slider, is the most versatile surgical retractor on the market, featuring a unique on-site retraction tension adjustment mechanism, allowing the device to be used in all surgical disciplines. It is available in multiple frames with different hooks – from sharp to half-blunt and blunt – and flexible options to meet the needs of every patient and procedure.

Receiving MDR certification for the Galaxy II self-retaining retractor is an exciting development for JUNE Medical in our mission to revolutionize surgical comfort. MDR certification requires a high burden of proof to demonstrate that a product is safe and effective and functions as intended. Therefore, obtaining this certification reflects the benefits our retractor can bring to operating rooms. This new accreditation, alongside existing FDA approval, will enable more surgeons worldwide to realize the full potential of the Galaxy II.“

Angela Spang, Founder and CEO, JUNE Medical

The Galaxy II is currently sold in 36 countries across Europe and the USA, where it enhances the quality of operations for patients. Professor Bijayendra Singh, Consultant Orthopedic Surgeon, Medway NHS Foundation Trust, UK, shared his experience: „As surgeons, we are always striving to improve outcomes for our patients. For me, that means improving every aspect of my procedure, and an important part is access. I cannot have too many assistants in hand surgery as they hinder my operation. By using the Galaxy II self-retaining retractor, I have better access and can complete the procedure more quickly, with excellent stability and control. We must continuously strive for excellence in surgery and utilize the best possible solutions for our patients.“

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