Whiteparish, UK, 3rd March 2011: One year on from the commercial launch of the ground-breaking PlasmaJet® surgical system for cutting and coagulating tissue in surgery, both Plasma Surgical and development partner MLE Creative Electronics have both achieved dramatic company growth. As the first device to harness the power of a pure plasma for surgery, the PlasmaJet system has seen outstanding early clinical success in the hands of key opinion leader surgeons as a very safe alternative to electrosurgery. Following this growth, both MLE and Plasma Surgical now collectively employ 110 personnel, with both companies recently opening new facilities within the UK and US respectively.
MLE’s technical expertise in medical Power Supply design, as well as extensive capabilities in embedded processors and control made this electronics design company the ideal partner to co-develop the PlasmaJet with the technology’s originator, Plasma Surgical. The capability of the PlasmaJet system today has moved beyond the original concept, having evolved greatly under MLE’s expert engineering development team who responded immediately and intelligently to meet and optimise Plasma Surgical’s final product objectives cost effectively.
The PlasmaJet system uses a pure plasma controlled by novel electronics to cut and simultaneously coagulate all tissues, including bone, with minimal damage to the surrounding structures. The electrically neutral nature of this plasma scalpel provides a very safe alternative to the use of electrosurgery, and eliminates the risks associated with exposure to high voltages and passing electrical current through the patient’s body. Used in both conventional open and laparoscopic or keyhole surgical procedures it can greatly reduce the risk and duration of complex surgical procedures, and in some cases reduce a patient’s hospital stay.
“As the first device to use a pure plasma for surgical purposes, the requirements for both the power supply and the control electronics of the PlasmaJet system are technically very complex,” explained Nigel Harley, Director of Strategic Development, MLE. “Understanding both the underlying scientific principles behind this device as well as the medical needs, such as a low EMC emissions profile and a regulatory compliant universal power supply, was key to our successful development of the console for this highly innovative surgical tool.”
MLE’s use of specialised techniques to create an ingenious medical power supply means that the PlasmaJet system can be plugged in and ready to use anywhere in the world, since it is fully compliant with the latest regulations and international specifications. The PlasmaJet console contains three embedded processors; the largest controlling the graphical user interface, controls, indicators, as well as plasma generation. The power supply requires two smaller processors to control mains side sequencing and temperature with plasma ignition.
Following the initial experience with a device designed for coagulation, MLE has continued to work with Plasma Surgical in the development of the present system that combines both cutting and coagulation capability, and supports the company in the manufacture of the console. Due to the complexity of the design of the PlasmaJet system, MLE will continue to be responsible for nurturing future design upgrades and ensuring an uninterrupted global supply of this exciting product.
“Within MLE we have found a true partner who has exceeded all of our expectations when it comes to developing an innovative medical device, both in terms of technical ability and understanding of our brief,” concludes Peter Gibson, CEO of Plasma Surgical. “We look forward to many more successful years of design and manufacturing partnership with MLE.”
ABOUT MLE Creative Electronics:
www.ml-electronics.co.uk
MLE is a highly approachable UK-based technology and product development company specialising in electronic product design, development and bespoke assembly services. Working in partnership with its customers MLE has helped to bring many novel products to market across a wide range of market sectors for companies such as Ferrari and QinetiQ, through to Wound Solutions and Plasma Surgical Ltd.
MLE holds 15 years of experience in designing for the highly specialised, regulatory controlled, safety-critical medical and healthcare market places. For medical device design and healthcare product development MLE designs electronic products that would require typically FDA 510k approval, ISO13485 and also IEC60601, the UK/European medical device directive. Within these standards there are many stringent validation and verification requirements, for example ultra-low leakage current requirements for surgical laparoscopic devices. MLE understands these regulatory obligations.
The expertise of its strong engineering team spans analogue and digital design, including embedded systems, DSP, power supply technology, motor drives, instrumentation and software. Adopting a five-stage design process accompanied by a creative consultative approach to product development, MLE ensures intelligent, friendly and cost effective technology and product commercialisation for its customers.
ABOUT Plasma Surgical:
www.plasmasurgical.com
Plasma Surgical was formed in 2000 by technology leaders inspired by the potential to transfer the principles of plasma physics from the engines used to position satellites in space and apply these in medicine. From this, a new standard in surgery was born – plasma surgery – and with it PlasmaJet, the first true plasma surgery system. This important advancement is helping surgeons perform better surgery and maximize clinical benefits for their patients.
The PlasmaJet system generates a pure plasma – a new energy source for use in surgery that offers a more safe and effective means of cutting and coagulating a wide range of tissues without the use of any external electrical current. Patients benefit from a much reduced depth of tissue damage and the elimination of alternate site burns, as seen with the current standard of electrosurgery techniques.
Plasma Surgical continues to develop and advance the unique applications of plasma surgery for a variety of surgical specialties with an executive team of highly-experienced professionals with proven backgrounds in the medical device industry and surgical equipment technology.
