A home device for treating peripheral arterial disease Peripheral arterial disease (PAD) affects millions of people worldwide and is projected to rise due to the increasing incidence of diabetes. An innovative medical device comes to revolutionise PAD treatment at home, offering improved blood circulation in lower limbs and healing of associated wounds. Health © Otivio PAD is caused by lipid deposition on the walls of peripheral arteries, causing reduced blood circulation to muscles and skin. To reduce impact and risk, individuals must stop smoking, follow healthy nutrition and exercise. As the condition worsens, patients lose their ability to walk and suffer great pain, while the likelihood of limb ischaemia, vascular surgery or amputation increases. Proprietary technology allows PAD care at home Current non-surgical solutions are uncomfortable to use, and the treatment has a long duration, with negative impact on patients’ quality of life. To address gaps in PAD care, the EU-funded FlowOx project has developed a cost-effective and clinically promising home treatment solution that doesn’t require surgery. “Our goal was to provide clinical evidence for the manufacture and commercialisation of the FlowOx™ system which halts or reverses the progression of PAD to the benefit of patients,” outlines project coordinator Iacob Mathiesen. The FlowOx™ medical device provides pulsating negative pressure therapy (PNPT) in the lower limbs, which improves blood circulation and oxygenation. Within seconds, PNPT increases the transmural pressure therefore increasing micro- and macro-circulation. Patients are advised to use the device 2 hours per day, split into smaller time slots to suit their normal daily routine. Results to date demonstrate that when applied consistently, PNPT functions like exercise in a way, revitalising the natural endothelial function of even the smallest blood vessels. This reduces PAD-associated pain and leads to visual changes in wound status within 2-3 weeks of use. After 8-10 weeks of continuous treatment, there is a significant increase in the rate of wound healing in patients. Project activities and future prospects The University of Salford, a FlowOx project partner, designed a randomised control trial to obtain compelling clinical evidence for the efficacy of the FlowOx™ device. More than 20 devices were used on patients for more than 6 weeks. “We had to redesign our trial and focus on selected patient cases as we experienced challenges associated with very advanced disease,” emphasises Mathiesen. Clinical trial observations and feedback from market introduction have also suggested further optimisation to overcome certain shortcomings and increase device usability. Partners updated system requirements specifications, performed risk analysis and incorporated several important new technical features into the new device. The overall design was modernised while maintaining a similar manufacturing cost. PAD-related healthcare costs are estimated to be between USD 210 and 380 billion per year. Through FlowOx™, project coordinator Otivio and project partner Innokas Medical have the opportunity to enter the PAD market and gain a strong market position for PAD home treatment. Efforts so far to introduce the device in Germany, Ireland, Scandinavia and the United Kingdom through a distributor network have proved promising. Device evaluation has taken place in 15 hospitals to date, and early sales in Ireland and Norway provide an indication of device acceptance. With a view to the future, Mathiesen is confident that, “while existing treatments fail, FlowOx™ offers a baseline intervention that works well in conjunction with current gold standard and first-line treatments, increasing our belief in the overall concept.” The next step is to apply for market approval in the United States. Keywords FlowOx, blood circulation, peripheral arterial disease, home treatment, diabetes, pulsating negative pressure therapy, wound healing
