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Innovation that’s getting to the heart of the matter

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.

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.“