The Association of British Healthcare Industries (ABHI) has launched an Industry Recommendations document to help the Government improve the commercial climate for the medical technologies industry.

Enhancing Patient Care in the NHS: The Role of Medical Devices outlines a number of measures that the UK Government should take to support the NHS innovation agenda and stop excessive bureaucracy stifling the contribution of medtech companies.

The ABHI recommends that the Government should:

• maintain the current regulatory regime

• do more to include clinicians in procurement processes

• help the NHS to plan ahead for uptake of new technologies

• develop more flexible payment systems

• include the medtech sector in official economic strategies

• encourage healthcare professionals to work with industry, ensuring their better understanding of the ABHI Code of Business Practice.

Richard Phillips, Chairman of the ABHI's Public Affairs Policy Group, said: "This document is an important step in helping policy makers to understand the needs of our industry. It comes at a crucial time, with the NHS budget set to drop in the coming years.

"Our Industry Recommendations document not only demonstrates the benefits of medical technology, but also points out the measures necessary in order to help the British medical technology sector continue to thrive.

"Now is the time for industry to seize the initiative and work with the NHS to show that early and broad uptake of medical technologies can reduce patient pathway costs and improve patient care, whereas making short-term spending cuts on medical technology will lead to long-term costs and poorer patient outcomes."

UK companies exhibiting products to assist mobility and independence reached customers from across the world at Rehacare 2009 in Düsseldorf.

The four-day show is the world's leading exhibition for assistive technology and rehabilitiation products.

Companies in the UK pavilion were visited by distributors and health professionals from Europe, the Middle East, Australia, China, the USA and elsewhere.

Charlotte Fraser, International Manager at Medilink Y&H, regional sector specialist for UKTI, noted: "As the population in the UK and Europe increasingly ages, attention is focusing on the need to provide innovative support through products and services that enable people to live more independently and reduce the time they spend in hospital or in care. This is an area that the UK specialises in, and it was great to see how much international interest there were in UK products at the show."

Some of the UK companies showcasing their products were:

• Specialised Orthotic Services Ltd, which manufactures bespoke seating solutions for people with complex postural requirements.

• Therapy World, which showcased its range of hydrotherapy and aquatic therapy products for use after orthopaedic surgery or injury.

• Care and Independence, whose range of slings and harnesses included the high-comfort Glove Slings, made with computer-aided laser technology.

• Nomad, whose wheelchairs are made to order and submitted to rigorous quality assurance checks.

Gordon McQuilton MBE, Managing Director of Specialised Orthotic Services Ltd, said: "Rehacare was a great platform for showcasing UK innovation, and as such we had exceptional interest from a number of countries including Europe, Australia, Iceland, the US and China. Specialised Orthotic Services is already established as a market leader across the UK and we are now looking to expand globally."

The UK Pavilion at Rehacare 2009

Novartis’ biological medicine Ilaris (canakinumab) has become the first drug approved in the EU for patients as young as four years old with cryopyrin-associated periodic syndrome (CAPS).

The approval of Ilaris as an orphan drug is based on trial evidence that it produced rapid and sustained remission of CAPS symptoms in up to 97% of patients.

CAPS is a rare lifelong auto-inflammatory disease with debilitating symptoms and few treatment options. Monoclonal antibody Ilaris selectively targets and blocks interleukin-1 beta (IL-1ß), the trigger for inflammation and tissue damage in CAPS patients.

Ilaris is the only medicine approved in the EU for CAPS patients as young as four years old, and for patients with the most debilitating form of CAPS, neonatal-onset multisystem inflammatory disease (NOMID).

“We are excited by the latest approval because Ilaris represents a significant therapeutic advance for patients with this debilitating and sometimes fatal disease,” said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. “Ilaris is the outcome of our pathways-driven search for innovative medicines that are tailored to the needs of patients.

“Initially we studied Ilaris in a very rare disease with a well-understood genetic profile, and now that its efficacy has been proven, we are able to move ahead rapidly with development in other diseases characterised by the same inflammatory process.”

The regulatory submission was supported by data showing that Ilaris produced rapid and sustained remission of symptoms in up to 97% of CAPS patients, with most of them responding within hours of the first injection.

“In CAPS studies, symptoms improved within 24 hours after patients received a single dose of Ilaris. The disease was barely detectable in the blood after two weeks and the remission of symptoms was sustained for six months,” said Helen J. Lachmann, MD of the UK National Amyloidosis Centre at the Royal Free and University College Medical School in London. “By effectively turning off the disease activity, Ilaris has the potential to transform patients’ lives by offering long-term control of their disease.”

The accelerated EU decision follows approvals in the US and Switzerland, where Ilaris was granted priority review in view of the significant unmet medical need.

Studies with Ilaris are ongoing in other diseases in which IL-1ß plays an important role, such as chronic obstructive pulmonary disease (COPD), type 2 diabetes, systemic juvenile idiopathic arthritis (SJIA), and gout.

New data show that patients have higher overall treatment satisfaction with one daily injection of Victoza (liraglutide, 1.8mg dose) than they do with two daily injections of exenatide (10μg dose).

The data from the LEAD6 trial was recently presented at the 20th World Diabetes Congress (International Diabetes Federation).

Specifically, among the 379 patients who completed the Diabetes Treatment Satisfaction Questionnaires (DTSQ) during the trial, those taking once-daily Victoza perceived less hypoglycaemia (abnormally low blood sugar levels) or hyperglycaemia (abnormally high blood sugar levels) compared to those on twice-daily exenatide.

“The study shows Victoza is associated with higher patient satisfaction compared to exenatide,” said Professor Bain, Chair in Medicine (Diabetes) at Swansea University and Diabetes Lead Clinician for the ABM University Health Board.

“It is important to consider patient-reported outcomes data, because if a patient is satisfied with his or her treatment they are more likely to comply with the treatment over the long term, which is necessary in type 2 diabetes management,” he added.

Treatment satisfaction was also evaluated in patients who were either switched from twice-daily exenatide to once-daily Victoza or continued on once-daily Victoza for another 14 weeks. In these cases, switched patients had improved satisfaction compared to those who continued on Victoza from weeks 26-40.

Medtech innovation is the effective application of new technology to improve healthcare. Stefano Di Lullo of Sorin Group looks at a crucial new example: the power of intelligent remote monitoring to break down barriers between the clinician and the patient's everyday life.

Healthcare was transformed in the first half of the 20th century by the invention of a number of medical devices that enabled physicians to collect data about diseases in a way that had not been possible before. Inventions such as the thermometer, stethoscope, microscope, ophthalmoscope, laryngoscope and X-ray enabled doctors to understand in far greater detail how various diseases change the human body and affect health. With an ever-expanding database, healthcare professionals were able to specialise and develop a detailed understanding of diseases.

Developments in medical technology and in healthcare delivery have always gone hand in hand. Now, remote monitoring - which promises to deliver more data than ever before for chronic diseases - has the potential to shape the future of patient care.

Keeping in touch

The role of telecommunications in medical technology has greatly increased in the last decade. It is now possible to collect patient information without the patient attending a hospital or doctor's surgery or office. This represents a breakthrough in terms of the amount of data that can be collected, and the number of people that can be treated by a healthcare delivery system. Current telemedicine systems range from patients self-reporting via telephone to implanted devices communicating data to healthcare professionals via secure servers.

Remote monitoring - the collection of patient data at a site where the patient is not present - is most valuable for chronic diseases such as diabetes and heart disease: these conditions require frequent monitoring to control symptoms and ensure the patient's well-being while the patient gets on with life outside of the clinical setting.

In the treatment of diabetes, remote monitoring enables physicians and patients to track blood sugar levels and changes in activity, diet and medication, providing the healthcare professional with a clear picture of the condition and its impact on the patient. The data can also help patients to self-administer appropriate amounts of medication in response to dietary and activity changes. In the treatment of heart disease, remote monitoring has the capability to assist the 1.7 million people in the UK diagnosed with arrhythmia - a condition that can have fatal consequences if not managed properly.

Basic remote monitoring systems involve the patient reporting self-assessments of symptoms over the telephone and then receiving verbal advice and education. While this form of remote monitoring certainly has benefits for healthcare delivery, its usefulness is constrained by the fact that the patient needs to support the process actively and input the information. If the patient is away from home, loses interest or becomes confused by the equipment, then the system may break down.

A more sophisticated alternative is remote monitoring based on information from a medical device - for example, an implantable cardiac rhythm management device. In this model, the physician is able to collect data from the device and establish its functional effectiveness in a completely non-invasive way. This works by the implanted device 'communicating' with a piece of hardware in the patient's home, typically the bedroom. However, this type of remote monitoring presents healthcare professionals with a new challenge: how do they identify the data that are most relevant to patient management?

Handling the data

For remote monitoring of implantable cardiac rhythm management devices, marrying the device to a state-of-the-art data management system will be a key future requirement.

Some recent implantable cardiac rhythm management devices adjust automatically and continually to changes in arrhythmia. This is possible because the devices use algorithms that accurately predict the course of cardiac diseases such as atrial arrhythmia and heart failure. These intelligent implantable devices are a natural candidate for incorporation into a remote monitoring system, as they have the potential to empower healthcare professionals to understand the individual patient's disease experience without the patient leaving their home. In addition, such technology goes beyond providing warning alerts about potential disease deterioration, and can be termed an 'intelligent remote monitoring system.'

Sorin Group is currently developing a system of this kind. The data will be transferred securely from the implanted device to a Sorin Group data hosting system using technology from Orange. The implanted devices will draw on highly specific algorithms that adapt to the natural functions of the heart, measuring vibrations generated by heart contraction. Data provided by the algorithms could enable physicians to monitor the development of acute cardiac decompensation based on patient activity and breathing, as well as predict the course of the disease. It is believed that this technology will benefit the medical community through time savings and early intervention. Being able to undertake preemptive action could save healthcare delivery systems money, since complex surgical procedures and long hospital stays (as well as readmissions) may be avoided.

Intelligent remote monitoring promises a system that is better for the patient on two levels. Firstly, the patient will not be required to attend routine appointments to check on the state of the implanted device: instead, face-to-face consultations with their doctor can be spent discussing their condition in detail. Secondly, the patient will benefit from reassurance that they are being continually supported and their health is being proactively monitored.

From the healthcare professional's perspective, remote monitoring provides time benefits. Research has shown that with the assistance of remote monitoring, in-office visits can be scheduled at yearly intervals without compromising patient safety; indeed, patient safety is generally enhanced by the use of remote monitoring. The literature also reports that existing telemonitoring solutions reduce physician time per patient by approximately 40% - so imagine what could be achieved with intelligent remote monitoring systems!

The remote monitoring paradigm

Building an intelligent NHS

Professor John Morgan of Southampton University, a key opinion leader in remote monitoring technology, has pointed out that for the past decade there has been a high level of expectation about the use of new technology to manage chronic diseases - an excitement sparked when telemedicine was first introduced. However, the excitement has not necessarily led to changes in clinical practice.

The main sticking point has been the requirement for clinical evidence in a real-world setting. NHS decision makers need to see that embracing new technology will offer benefits to patients, physicians and the healthcare system, and that such technology can be effectively integrated into clinical practice.

To this end, Professor Morgan is currently working on developing a multi-centre study of remote disease management processes to evaluate this approach. He is focusing on remote monitoring in cardiology, as this is the most developed area, but he also believes that remote monitoring could offer benefits for the management of renal, neurological and skeletal conditions.

Outside the UK, research is under way in Europe to solidify the database for remote monitoring, and randomised clinical trials are being conducted to build a robust case for its health benefits.

The next steps

As technology evolves, people and institutions reform their behaviour and practices to incorporate it. The management of health has, until now, been based on face-to-face encounters between a patient and a doctor where information is conveyed and examinations are conducted. Remote monitoring allows the patient to be managed via the monitoring of data and further assessment during consultations. Intelligent systems will provide an array of detailed data that enhance the patient consultation instead of replacing it. This technology has the potential for smooth integration within our healthcare system.

The medtech community continues to innovate and provide new tools for managing patients. Intelligent remote monitoring will propel the patient into an environment in which their cardiac health, and other aspects of their wellbeing, can be cared for continuously. Healthcare professionals, helped by intelligent algorithms, will be armed with a powerful tool to develop tailored treatment approaches that are more effective for the patient and for the NHS.

Implemented within our healthcare system, this technology could represent a true example of innovation. It has the potential to help specialists further understand chronic diseases, save resources, see more patients, and deliver the best possible standards of care.

Stefano Di Lullo is President of the CRM Business Unit of Sorin Group. Sorin Group and Orange Business Solutions are developing an intelligent remote monitoring solution for patients implanted with cardiac rhythm management (CRM) devices. For more details, visit www.sorin-crm.com.

   

Healthcare professionals will be armed with a powerful tool to develop tailored treatment approaches that are more effective for the patient and for the NHS.

NICE has recommended the use of antidepressants to treat patients with moderate or severe depression, or for those with mild symptoms when other interventions have not been successful.

However, the Institute has urged against the routine use of antidepressants to treat patients with only mild symptoms.

These recommendations form part of updated guidance, produced for NICE by the National Collaborating Centre for Mental Health, on the identification, treatment and management of depression in adults in both primary and secondary care.

The guidance states that drug treatment should be considered for patients with a past history of moderate or severe depression, for those with sub-threshold depressive symptoms that have been present for at least 2 years, or for patients with mild depression that persists after other interventions.

For those with mild symptoms, the guidelines recommend initial treatment with either individual guided self-help based on the principles of cognitive behavioural therapy (CBT), computerised cognitive behavioural therapy (CCBT) or a structured group physical activity programme.

For the treatment of moderate or severe depression, NICE encourages a combination of antidepressant medication and a high-intensity psychological intervention such as CBT.

The guidance also adds that patients who have benefited from antidepressant treatment should be supported to continue treatment for at least six months after symptoms have improved, to reduce the risk of relapse.

Professor Ian Anderson, Professor of Psychiatry, University of Manchester and Chair of the Guidance Development Group (GDG), said: “The treatment of depression can be difficult. Everyone who has depression has their own story and their treatment needs to be individually tailored for them.

“These guidelines offer choice and will support doctors and those with depression to find the best treatment for them. Good communication between doctors and their patients is essential and the decision as to which treatments to use should be a decision made in partnership.”

NICE has published final guidance recommending the use of Lilly’s Effient (prasugrel) in combination with aspirin as an option for preventing blood clots in the arteries of people with acute coronary syndromes.

Acute coronary syndromes are a group of heart problems which occur due to narrowed coronary arteries. These heart problems cause chest pain and specific types of heart attack.

Prasugrel is a drug that can reduce or prevent the formation of blood clots in arteries by reducing the clumping together of platelets in the blood.

The guidance recommends prasugrel in the above indication, but only when immediate primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction (a specific type of heart attack) is necessary or a blood clot blocking a stent has occurred during treatment with clopidogrel.

It is also approved for patients with acute coronary syndromes who have diabetes mellitus.

Dr Carole Longson, Director at NICE, said: “There are a range of heart problems classed as acute coronary syndromes – these conditions have a huge impact on the individuals affected. This new guidance recommending prasugrel in combination with aspirin will offer an additional treatment option for these specific individuals at risk of blood clots.”

Shire’s phosphate binder Fosrenol (lanthanum carbonate) has gained approval in the EU for an extension of indication through the European Mutual Recognition Procedure.

This approval paves the way for Fosrenol’s use to control hyperphosphataemia in chronic kidney disease (CKD) patients who are not on dialysis, with a serum phosphorus level greater than or equal to 1.78mmol/L (5.5mg/dL).

The extension was sanctioned by the Swedish Medicines Products Agency as reference member state.

“Failure to control phosphate in the earlier stages of chronic kidney disease carries well-documented risks, and is associated with reduced bone health and poor cardiovascular outcomes,” said Dr Alastair Hutchison, Manchester Royal Infirmary.

“The extension to the existing indication for Fosrenol provides nephrologists in the EU with an important additional option to help tackle the challenge of uncontrolled phosphate at an earlier stage in the progression of kidney disease, before the need for dialysis treatment.”

“This is an important development in helping CKD patients better manage their elevated phosphate and we are pleased that Fosrenol is now approved as a treatment option for these patients in the EU,” added Gian Piero Reverberi, Senior Vice President, International Specialty Pharmaceuticals, Shire. “We are firmly committed to serving the needs of renal patients and ensuring that Fosrenol is available to the prescribers and patients who can benefit from it.”

A unique wearable sticking plaster from a Scottish company for the treatment of non-malign skin cancers has received CE Mark approval.

The Ambulight PDT plaster from Ambicare Health Ltd is the world's first skin cancer treatment using a small disposable light-emitting plaster.

This therapy enables healthcare providers to shift treatment of skin cancer from hospitals to GP surgeries or outreach clinics.

The plaster delivers photodynamic therapy treatment (PDT) directly to the skin lesion site. It is used together with a prescribed pharmaceutical for the treatment of non-melanoma skin cancer.

Pilot clinical trials have indicated that the therapy is as effective as conventional techniques while offering less pain and greater convenience.

PDT is regularly the first line of treatment in Europe for non-melanoma skin cancer. It involves a day-patient appointment at the hospital, where a large static PDT light source is used. The alternative treatment methods are surgery, topical creams and cryotherapy, which can cause pain and scarring.

Dr Ian Muirhead, CEO of Ambicare, said: "This is a key milestone and a significant achievement for the company. We are now actively engaging with potential partners for the distribution of this revolutionary product in Europe. We will also be taking Ambulight PDT through regulatory approvals in additional countries, such as USA and Australia. This will allow us to bring the benefits of our technology to patients in the wider global market."

The number of skin cancer lesions requiring treatment is doubling every 10 years; by 2015, that would give Ambulight a total addressable market approaching £1 billion.

Ambicare also plans to use Ambulight technology in applications for the treatment of cosmetic skin conditions, including acne and wrinkles.

Based in St Andrews, Ambicare Health Ltd is a leading developer of wearable light sources for medical and consumer healthcare.

Ambulight PDT

A new low-cost technology offers a patient-focused platform for managing health information at home.

Cambridge Consultants has launched VenaHub, a wireless data collection and online data aggregation system that enables patients to manage chronic conditions and interact with their healthcare network.

VenaHub employs a small pocket device to capture data from a user's ecosystem of wireless medical devices, which it integrates into a customisable online health information portal.

"Current solutions in the telehealth space are expensive, which means none of the parties involved want to pay for them," said Mike Dunkley, Vice President of Cambridge Consultants. "But the novel, compact, and portable VenaHub is cheap and can plug into the USB port of any PC. Critically, it can also collect data from devices even when it's not plugged into a computer.

"This technology could not only disrupt the current medical home market, but could overcome the reimbursement barrier that has prevented connected health solutions from being widely deployed."

VenaHub's web interface enables users to select applications to suit their own needs and conditions. For example, an asthma patient could tailor their portal to see charts of their inhaler use, reminders of prescriptions or appointments, lung function data and the pollen forecast.

The technology is based on Cambridge Consultants' Vena wireless healthcare device platform, which incorporates the Bluetooth Health Device Profile for the secure transport of medical data.

"We believe VenaHub brings functionality that could accelerate widespread adoption of home health practices," said Paul Williamson, Head of Wireless Medical at Cambridge Consultants. "We have created a low-cost solution that could be brought to market quickly while targeting the move to mobile platforms in the medium term."

Cambridge Consultants, based in Cambridge (UK) and Boston (US), is a member of the Continua Health Alliance.

VenaHub