JUNE Medical’s Galaxy II self-retaining surgical retractor receives MDR certification
JUNE Medical’s 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 selfretaining retractor brings to improving patient safety and the overall quality of healthcare across all surgical specialties.
Angela Spang, founder and owner of JUNE Medical, commented: “Receiving MDR certification for the Galaxy II self-retaining retractor is an exciting development for JUNE Medical in our pursuit to revolutionise 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.”
Professor Bijayendra Singh holds a Galaxy II self-retaining surgical retractor
The Galaxy II retractor’s self-retaining cam lock system transforms the comfort, quality and ease of wound visualisation in surgeries, allowing single-handed adjustments and removing the reliance on theatre assistants to optimise 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.
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 at 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.”
For more information, visit: https://junemedical.com/galaxy-ii-overview/
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