Media Release 08 Aug 2007

World First Australian ‘blood pump’ prevents amputations

In a major breakthrough for those at risk of vascular disease, researchers have saved a man’s leg from amputation by stimulating the growth of blood vessels.
“This treatment offers hope to patients and their doctors when amputation appears to be the only option,” explains Dr Rodney Lane, Royal North Shore Hospital vascular surgeon and Executive Director of Research at AllVascular.

This is a significant advance for the 340,000 patients in the Western World who lose a leg to surgical amputation every year due to peripheral vascular disease.
Vascular disease is most commonly caused by diabetes and rates are likely to continue to rise with the increasing rates of diabetes and obesity in the community.

First patient – a Newcastle father of two

Newcastle father of two, Malcolm Brown developed peripheral vascular disease in late 2005 from a clot in the artery near his knee. This severely restricted the blood supply to his leg below the knee.

Malcolm’s foot lost sensation and became cold and white. Gangrenous ulcers formed on his feet and toes as the flesh started to die.

Three vascular surgeons examined Malcolm and, based on the extent of his disease, concluded that the only treatment option was a major lower limb amputation.

Fortunately for Malcolm, AllVascular had initiated a research project three years ago to see if amputation in patients with conditions like Malcolm’s could be prevented by tricking the body into creating a new blood supply.
In a world first, the team devised a treatment where a Peripheral Access Device (PAD™) was implanted into the femoral artery located in the thigh.

“The device was connected to a blood pump outside the body. It allowed simple, repeatable access to the femoral artery. This, in turn, increased the pressure of the blood flow above the blockage caused by the clot,” explained AllVascular’s Dr Mark Phillips

The resulting increase in blood pressure caused a 250% increase in the blood flow to the foot whilst stimulating new vessels to grow.

“After 50 hours on the pump over a five day period, Malcolm’s foot became warm and pink with marked improved sensation and notable healing of the ulcers on his feet and toes,” Dr Lane said.

Malcolm’s leg was saved by stimulating the growth of his own blood vessels which ultimately restored the blood flow to his leg.

It has been twelve months since Malcolm’s operation and by all accounts, it has been very successful. The future for Malcolm looks bright and it is unlikely he will require future intervention. Malcolm lives with his wife and children and hopes that one day he may be able to return to work.

Trials with five more patients

Royal North Shore Hospital, North Shore Private Hospital and Dalcross Private Hospital are continuing the device trials to prove its effectiveness and patient suitability. The initial pilot trial has five patients and the success of
Malcolm’s treatment, as the first patient, has been very exciting.

“The worst part of my job as a Vascular Surgeon is amputations. Often there is no choice, as saving the life of the patient is of course paramount. I am very pleased to see the work we have been doing at AllVascular could give hope to those facing a lower limb amputation” said Dr Lane.

“We are extremely proud of this device and its potential to help the hundreds of thousands of patients who, each year, face lower limb amputation. We will shortly be adding this to the suite of innovative products developed and manufactured by Advanced Surgical Design and Manufacture (ASDM) for the world and we’re confident it can achieve singular global success.” A/Prof Greg Roger,
ASDM’s Managing Director concluded.

All-Australian innovation and design team

This innovative procedure was part of the HELP trial (Hypertensive Extracorporeal Limb Perfusion) and is an excellent example of high quality, corporate-based clinical research, with researchers from AllVascular Pty and ASDM working with Royal North Shore Hospital

The Peripheral Access Device was developed by AllVascular and co-designed and manufactured by ASDM.

The project was funded by AllVascular and ASDM with support from AusIndustry in the form of a Biotechnology Innovation Fund grant and a Proof of Concept grant from the NSW Department of State and Regional Development.

Facts & Figures
• Worldwide there is one lower limb amputation every 30 seconds
• In the Western world there are 340,000 major lower limb amputations every year due to arterial disease alone
• Each amputation costs ~US$60,000 in direct costs and ~US$160,000 in indirect costs
• In the US alone US$500 million per annum is spent on amputations for diabetes
• Only about 30% of all amputees will ever walk again – despite the use of prostheses

Further trials
Patients will be required for further trials of the device.
People interested in being part of the further trials can register online at www.allvascular.com or by phone on 1300 767 902

Media Conference:
WHEN: Wednesday 8th August at 10am
WHERE: Vanderfield Building, Reserve Road,
Royal North Shore Hospital
WHO: Malcolm Brown, First patient
Dr Rodney Lane, RNSH Vascular Surgeon, Executive Director of Research, AllVascular
Dr Mark Phillips, General Manager, AllVascular and
A/Prof Greg Roger, Managing Director ASDM

Following the media conference, you are invited to tour and film at ASDM, the working laboratory where the device was manufactured. ASDM is located behind RNSH at Unit 2 / 12 Frederick St, St Leonards.

Media Contact RNSH: Penelope Little, Corporate Communications 0413 025 742 / 9926 7199

Media Contact AllVascular: Lindsay Beaton, Radar Investor
Relations
0412 702 860 / 02 82563317

Media Contact ASDM: Tracy Pendergast
9415 4528 / 0411 034 868

About All Vascular
AllVascular is an innovative Australian-owned and based company, whose corporate focus is on researching, developing, commercialising, marketing and selling restorative/reconstructive medical devices, including for the treatment of arterial and venous disease into global markets.
www.allvascular.com

About ASDM
ASDM is committed to excellence in every aspect of the surgical design and manufacturing business.In addition to Australia, ASDM supplies products, technology and advice to customers throughout the United States, Europe, and Asia.
www.asdm.com.au

About Royal North Shore
Royal North Shore Hospital has built an impressive record of medical research that ensures their patients receive the best clinical treatment. They have a commitment to take research from the “bench top to the bedside”.
http://www.nsccahs.health.nsw.gov.au/rnsh/

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