Innovation that’s getting to the heart of the matter

Graham Wardlow and Paul Lyon were prepared to take a decade-long journey in order to achieve a breakthrough product that has been enthusiastically received in the life sciences industry
Graham Wardlow and Paul Lyon were prepared to take a decade-long journey in order to achieve a breakthrough product that has been enthusiastically received in the life sciences industry

Magnesium Elektron has developed a unique alloy for devices that are revolutionising the treatment of difficult conditions such as coronary heart disease

By Mile Cowley

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When Graham Wardlow and Paul Lyon made their way to the stage to receive the Product of the Year Award on behalf of their company, Magnesium Elektron, at the Bionow Life Science Industry dinner – the ultimate accolade in what are the Oscars for the sector – for them it was not only a punch the air moment but also the final endorsement for a relatively high-risk, decade-long breakthrough project.

The revolutionary SynerMag® alloy developed by Magnesium Elektron, which carried off the top prize, is now set to make the company a leading supplier to the global bioresorbable metallic implant market because it dissolves safely in the human body.

It is currently being used as the key structural material in Magmaris, the world’s first clinically proven, bioresorbable metallic cardiovascular scaffold, which is manufactured by Berlin-based Biotronik, a leading international manufacturer of implants.

Because it is made of magnesium, which occurs naturally in the body, the Magmaris scaffold has key advantages over conventional permanent stents that can develop complications. These are caused by the risk of activating the immune system, which can lead in turn to conditions known as late stent thrombosis and restricted coronary vasomotion, which are both as unpleasant as they sound. When the Magmaris device is used to repair an artery, the scaffold resorbs naturally up to 12 months after the procedure. It simply disappears after it has done the job.

The fact that one of Magnesium Elektron’s SynerMag alloys is now used in a CE-approved device opens the door for this and further developments to be evaluated and potentially applied in a vast range of other medical implant procedures in which the implant is required only on a temporary basis. In fact, its full potential will only be exploited once the medical world has become fully aware of its capability and headed to Magnesium Elektron at its 35-acre plant in Swinton, Greater Manchester, to work out a joint solution.

Yet it is in the treatment of coronary heart disease where the benefits of SynerMag will first be realised. Since the early 1970s, major operations were performed to treat coronary heart disease. The move towards minimally invasive procedures and the implantation of stents to reopen clogged arteries has been a successful and positive step forwards. In more recent years, the desire to avoid restrictions and potential risks of permanent implants has led to the development of a product which will achieve the repair function of a stent, but then disappear.

That’s why Biotronik’s Vascular Intervention Division first approached Magnesium Elektron 10 years ago. The reason was obvious. Magnesium Elektron was already the established world leader in magnesium alloy production, holding more global patents on specialised magnesium alloys than any other company – and magnesium, because it is already present in the body and bioresorbable, was on the medical radar as a potential solution.

SynerMag alloys are made in a $2.5m dedicated manufacturing facility that is unlike any other in the world
SynerMag alloys are made in a $2.5m dedicated manufacturing facility that is unlike any other in the world

Magnesium Elektron was also known to have charted new metallurgical boundaries of magnesium alloy technology to take full advantage of magnesium’s unique chemical and physical properties, including its strength and its high specific stiffness. And the company was already a household name in global industries including aerospace, its lightweight corrosion-resistant and flame resistant products having set an innovation standard.

The end result is that the range of products in which the company’s solutions can be found appears endless – and possibly is – ranging from Apache helicopters to Rolls-Royce engines. It is currently working on a new range of lightweight seating alloys for airlines to help them meet their mantra of lower fuel costs and emissions.

It was the ability to apply the technology from its existing marketplaces to create the new platform technology for the life sciences arena which – according to Dr Liz Mear, Chief Executive of the Innovation Agency, which sponsored the Product of the Year Award – saw Magnesium Elektron get the nod against tough competition from other products, including those used to treat cystic fibrosis and iron deficiency anaemia in patients with IBS.
However, when Biotronik first came knocking in terms of finding a bioresobable magnesium implants, the life science arena was an entirely new and untried market for the British supplier. And as with any solution that involves patient health, it proved no easy ride.

With a significant track record in R&D – some 15% of Magnesium Elektron’s 150-strong workforce in Swinton is dedicated to core research – the original thought was that it would take around five years to develop.

To find a solution, in addition to the core R&D that was undertaken by Elektron, the company invested US$2.5m in establishing a dedicated manufacturing facility, incorporating state-of-the-art laboratories, casting, extrusion and heat treatment facilities, and named it the SynerMag Technology Centre. No other comparable facility can be found anywhere in the world. This has enabled Biotronik to produce scaffold struts just 150 microns thick, around the thickness of a piece of paper.

During the life of the project, the company achieved ISO 13485 certification, an internationally recognised quality standard for medical devices – so ensuring partner Biotronik conformed to the required regulations.

Patients have already been treated using Magmaris scaffolds as far afield as Australasia, but as yet it is not available in the UK. Early last year, 55-year-old Trevor Fairhurst received a Magmaris bioresorbable magnesium alloy stent in his native New Zealand. The operation was urgent as 90% of one of his heart vessels had become blocked, causing ongoing angina and chest pain.

“Since the procedure, I have felt over the moon, because the energy has returned, everything is coming back,” he said in a subsequent interview after returning to work.
Meanwhile, the success of SynerMag has also fulfilled the vision of both Graham Wardlow, who took over as managing director for the company shortly after it diversified into the bioscience arena, and Paul Lyon, who heads up the programmes technology team.

When the two put together the team to run with the Biotronik programme, they set out a vision to become the world’s leading supplier of bioresorbable metallic materials for the medical industry. With a unique capability to carry out core R&D in collaborative partnerships and then scale this up to full commercialisation, it is a vision that has been achieved.

“We have an amazing group of talented individuals who have a real desire to make something happen,” says Graham Wardlow. “While we are very proud of our industrial heritage, in more recent years we have created a culture where we think of ourselves as a fresh, agile, technology company that is totally focused on the needs of our customers and capable of bringing new platform technologies to market.“