JUNE Medical’s Galaxy II® self-retaining surgical retractor receives MDR certification for its high quality and safety
JUNE Medical is proud to announce that its Galaxy II® self-retaining surgical retractor has received Medical Device Regulation (MDR – Regulation (EU) 2017/745) certification from BSI Group for its use in the European Union. This accreditation is testament to the value that this innovative self-retaining retractor brings to improving patient safety and the overall quality of healthcare across all surgical specialisms, including ENT, pediatrics, dentistry, vascular surgeries and many more.
The game-changing Galaxy II retractor’s self-retaining cam lock system transforms the comfort, quality and ease of wound visualization in surgeries, allowing single-handed adjustments and removing the reliance on theatre assistants to optimize staff time and patient safety. The newest addition to the range, the Galaxy II Slider, is the most versatile surgical retractor on the market, featuring a unique mechanism to adjust retraction tension in situ, allowing the device to be adopted in all surgical disciplines. It is available in multiple frames with various hooks – from sharp to semi-blunt and blunt – and flexible options to suit any patient and any procedure.
Receiving MDR certification for the Galaxy II self-retaining retractor is an exciting development for JUNE Medical in our pursuit to revolutionize surgical comfort. MDR certification requires a high burden of evidence to prove that a product is safe, effective and performs as intended, so obtaining this certification reflects the benefits that our retractor can bring to operating theatres. This new accreditation – along with an existing FDA approval – will allow more surgeons across the world to unlock the full potential of the Galaxy II.”
Angela Spang, Founder and Owner, JUNE Medical
The Galaxy II is currently being sold in 36 countries across Europe and the US, where it is improving the quality of surgeries for patients. Professor Bijayendra Singh, Consultant Orthopaedic Surgeon Medway NHS Foundation Trust, UK, explained his experience: “As surgeons, we always strive to improve outcomes for our patients. For me, that involves improving every aspect of my procedure, and one important part is access. I can’t have too many assistants in hand surgery as they are in the way of me operating. Using the Galaxy II self-retaining retractor gives me better access and allows me to finish the procedure faster, with excellent stability and control. We must continuously strive towards excellence in surgery, using the best possible solutions for our patients.”
