CE mark opens door to Europe for University spin-out
27 Ionawr 2014
Mae'r cynnwys hwn ar gael yn Saesneg yn unig.
University spin-out Asalus Medical Instruments, has been awarded the CE mark for its revolutionary product UltravisionTM
Ultravision is the first product to be launched by the company established to commercialise the inventions of the Welsh Institute of Minimal Access Therapy (WIMAT). It is an innovative new technology that clears surgical smoke produced during laparoscopic surgery.
The system rapidly clears the operative visual field of surgical smoke and simultaneously prevents its release into the operating theatre. This addresses a significant problem during laparoscopic surgery for both surgeons and nurses.
Based on a proven industrial technology that is a highly effective means of removing airborne particulates from the atmosphere, Ultravision was first conceived by Dr Neil Warren, a specialist at the forefront of minimally invasive surgery training. It was developed with support from the University's Proof of Concept fund, the Cardiff Partnership Fund.
Dr Warren, founding director of WIMAT and Asalus' Chief Scientific Officer, said: "Surgical smoke is a significant issue during laparoscopic surgery. Smoke rapidly builds up in the abdominal cavity, severely impairing the quality of the visual field and slowing down the procedure. The subsequent release of surgical smoke into the operating theatre is also unpleasant for the surgical team and there is a potential risk that chronic exposure may have long-term health implications.
"We have developed Ultravision because we know that the current solutions used in surgery are largely ineffective in meeting the needs of the surgical team. Ultravision silently, effortlessly and unobtrusively clears the visual field of surgical smoke and prevents its release in to the operating theatre to allow best practise in laparoscopic surgery."
Securing the CE mark is a significant milestone for Asalus, allowing it to appoint distributors and launch Ultravision in the EU over coming months.
With approximately six million laparoscopic procedures performed annually worldwide, the award of the CE mark allows hospitals to use the system on patients undergoing laparoscopic surgery in the European Union member states.
In parallel to being awarded the CE for Ultravision, the Company has also been awarded ISO13485 and ISO9001 quality management certification. This allows the Company to further develop Ultravision for other minimal access surgery applications and establish a product pipeline.
Dominic Griffiths, Managing Director of Asalus, said: "This is a significant achievement in the evolution of Ultravision and is crucial to our launch plans. We have already received overwhelming interest in Ultravision from both the surgical community and global distributors and we're excited about bringing Ultravision to market.
"This is the first of several innovative devices we hope to launch to improve the safety and efficiency of laparoscopic surgery. Our vision is to become a world leader in the development of new devices for advanced minimal access surgery, working with leading surgeons to identify and resolve issues commonly experienced when performing complex surgical procedures. Addressing these issues will make procedures easier and faster for the surgical team, safer for the patient and more cost-effective for the healthcare provider."