JUNE Medical is proud to announce that its Galaxy II® self-retaining surgical retractor has obtained Medical Machine Regulation (MDR – Regulation (EU) 2017/745) certification from BSI Group for its use within the European Union. This accreditation is testomony to the worth that this progressive self-retaining retractor brings to enhancing affected person security and the general high quality of healthcare throughout all surgical specialisms, together with ENT, pediatrics, dentistry, vascular surgical procedures and plenty of extra.
The sport-changing Galaxy II retractor’s self-retaining cam lock system transforms the consolation, high quality and ease of wound visualization in surgical procedures, permitting single-handed changes and eradicating the reliance on theatre assistants to optimize employees time and affected person security. The latest addition to the vary, the Galaxy II Slider, is essentially the most versatile surgical retractor in the marketplace, that includes a singular mechanism to regulate retraction stress in situ, permitting the machine to be adopted in all surgical disciplines. It’s accessible in a number of frames with numerous hooks – from sharp to semi-blunt and blunt – and versatile choices to go well with any affected person and any process.
Receiving MDR certification for the Galaxy II self-retaining retractor is an thrilling improvement for JUNE Medical in our pursuit to revolutionize surgical consolation. MDR certification requires a excessive burden of proof to show {that a} product is secure, efficient and performs as meant, so acquiring this certification displays the advantages that our retractor can carry to working theatres. This new accreditation – together with an current FDA approval – will permit extra surgeons the world over to unlock the complete potential of the Galaxy II.”
Angela Spang, Founder and Proprietor, JUNE Medical
The Galaxy II is at present being offered in 36 nations throughout Europe and the US, the place it’s enhancing the standard of surgical procedures for sufferers. Professor Bijayendra Singh, Advisor Orthopaedic Surgeon Medway NHS Basis Belief, UK, defined his expertise: “As surgeons, we at all times try to enhance outcomes for our sufferers. For me, that entails enhancing each side of my process, and one essential half is entry. I am unable to have too many assistants in hand surgical procedure as they’re in the way in which of me working. Utilizing the Galaxy II self-retaining retractor provides me higher entry and permits me to complete the process quicker, with wonderful stability and management. We should constantly try in the direction of excellence in surgical procedure, utilizing the absolute best options for our sufferers.”
