Low-profile balloon catheter for PAD launched

by emma 21. September 2011 13:54

Coyote Balloon Catheter

Boston Scientific has launched its new balloon dilation catheter, Coyote, to treat patients undergoing peripheral angioplasty procedures below the knee.

The Coyote Balloon Catheter is intended to help physicians when treating patients who have challenging obstructive lesions in the lower extremities.

With an ultra-low profile of 0.0174 inches, it promises to be highly deliverable and offer rapid deflation.

Balloon catheters are often used during peripheral angioplasty and stenting procedures to open blocked arteries.

J. A. Mustapha, Director of Endovascular Intervention at Metro Health Hospital in Wyoming, Michigan, said: “Its performance gives me greater confidence in being able to effectively treat patients with difficult anatomy who suffer from peripheral artery disease.”

The device is the latest in a series of balloon catheter products developed by Boston Scientific.  In June, the company launched its Mustang PTA Balloon Catheter, a 0.035 inch percutaneous transluminal angioplasty (PTA) catheter designed to be used in a range of peripheral angioplasty procedures.

Jeff Mirviss, President of Boston Scientific's Peripheral Interventions Division, said the new product launch “builds on Boston Scientific's global leadership in low-profile peripheral balloon angioplasty”.

Up to 9 million US patients suffer from peripheral artery disease, which is associated with high rates of morbidity.

Boston Scientific has begun marketing the product in the US, Europe and other international markets.

Mobile diabetes control system approved for EU

by emma 20. September 2011 22:32

cellnovo box, pump and handset (web)

The world’s first mobile-based system for diabetes management, developed by UK company Cellnovo, has received CE Mark approval for sale in the EU.

The innovative Cellnovo system (pictured) combines an insulin patch pump with a touch-screen mobile handset that wirelessly transmits real-time patient data to a web-based portal, enabling patients to keep track of their blood glucose control without needing to keep a diary.

The integration of medication delivery and monitoring technologies, completing the circle of type 1 diabetes control, is strengthened by Cellnovo’s recent agreement with US diabetes monitoring specialist LifeScan.

The successful OneTouch monitoring technology from LifeScan will be incorporated into the Cellnovo system, enabling that a very rapid fingerprick test can be used to generate readings.

The mobile handset is similar to the iPhone, while the patch pump is the smallest and most accurate on the market.

“Cellnovo has created the first insulin pump that combines form with function, essential qualities in a device that patients have to interact with 24/7,” said Dr. Pratik Choudhary, Clinical Lecturer in Diabetes at King’s College London.

Irl B. Hirsch, Professor of Medicine at the University of Washington, Seattle, USA, commented: “Cellnovo has combined advanced mobile and medical technology, which may create a paradigm shift in diabetes care.”

William McKeon, CEO of Cellnovo, described the CE Mark approval as “Cellnovo’s first step in a journey to bring this mobile diabetes management system to the world”.

Based in London, Cellnovo is a mobile healthcare company that specialises in diabetes management.

Export market report: the UK

by emma 19. September 2011 20:29

export market report

The UK medical device market is one of the biggest in the world, with growth relying predominantly on imports. But it is also a significant exporter of medical technologies. In the second of two articles looking at the domestic market, Medtech Business in association with Espicom takes a look at the UK medtech export market.

The UK is a significant global exporter of medical devices (including medical equipment and medical supplies) and remains among the world’s top 10. But the sector has faltered in recent years. Exports peaked in 2006 at US$7,238.5 million, but have fallen every year since then. In 2009, exports dropped to US$5,394.4 million – roughly the same level seen in 2005. The orthopaedic sector was hit especially hard in 2009. (For more details, see Figures 1–3.)

Consumables

Medical consumables were the largest individual export area in 2009, valued at $1,140.0 million,* or 21.1% of total exports. This was a fall of 3.8% compared with 2008, with a 2005–09 Compound Annual Growth Rate (CAGR) of –1.8%.

Consumables are defined as wound care products (medical dressings, sutures, sterile, surgical and dental goods), syringes, needles and catheters. Within this category, catheters and cannulae amounted to $279.7 million, virtually unchanged from 2008, but significantly lower than the 2005 level of $410.6 million. Exports of medical dressings amounted to $503.7 million, a fall of 8.3% compared with 2008.

figure1exportmarketreport

figure2exportmarketreport

Diagnostic imaging

Diagnostic imaging is not historically one of the UK’s stronger sectors. In 2009, UK exports of diagnostic imaging apparatus amounted to $1,131.3 million – 21.0% of the country’s total export market. In recent years, the electrodiagnostic sector has been its biggest source of growth. The 2009 total showed a fall of 0.1% compared with 2008, with a CAGR for 2005–09 of 5.4%.

Electrodiagnostic imaging exports amounted to $575.1 million, a rise of 23.4% over 2008 due largely to a big rise in MRI exports. Radiation apparatus exports were far lower at $83.4 million, although this too represented a strong increase of 28.2% on 2008 figures. Exports of imaging parts and accessories fell sharply in 2009, by 21.4% to $472.9 million.

Orthopaedic products

Exports of orthopaedic and prosthetic products saw a sharp fall in 2009. Exports totaled $1,231.5 million in 2008, but fell by 46.7% the following year to reach $656.2 million. Artificial joints fell by 67.1% to $71.5 million, while other orthopaedic/fracture appliances fell by 49.8% to $445.2 million.

As outlined in Medtech Business’s first UK market article (July 2011), imports in this sector also saw a sharp fall in 2009. Espicom suspects that much of the reduction is due to a change or relocation of multinational manufacturing and repackaging activities.

Patient aids

Exports of patient aids amounted to $1,054.5 million in 2009, a fall of 5.2% compared with 2008.

Portable aids fell by 8.0% to $762.1 million, while therapeutic appliances rose by 2.9% to $292.4 million.

figure3and4exportmarketreport

Dental products

Exports of dental products reached US$148.2 million in 2009 – 2.7% of the total. This is an increase of 4.1% over 2008; the total fell sharply in 2007, but has since recovered a little.

Dental cements amounted to US$70.2 million in 2009, a rise of 17.7% over 2008.

Leading destinations

In 2009, the single leading destination for UK exports was the US, with $768.1 million (4.2%) of total exports. The largest shipments to the US were diagnostic imaging products, which amounted to $188.8 million, 16.7% of exports in this sector. This was followed by consumables, which amounted to $136.5 million, 12.0% of exports in this product area. The US also received 31.7% of dental product exports, valued at $47.0 million. (See Figures 4 and 5 for more details.)

More than half of UK exports went to the EU-27 countries. Shipments totaling $3,016.7 million (55.9% of total exports) left the UK for the EU-27. The principal recipient within the EU was Germany, accounting for 13.4% of exports, valued at $720.6 million. Almost a quarter (22.3%) of diagnostic imaging apparatus exports went to Germany. Belgium was the single biggest importer of UK consumables (18.6%) and UK orthopaedic and prosthetic products (17.2%) – in both cases outstripping the US. Other leading destinations within the EU were France, Ireland and the Netherlands.

Next month, Medtech Business will look at the medical technologies market in France.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence.
*All figures are in US $. For further details of the 63 markets covered, please visit
www.espicom.com/outlookm1

figure5exportmarketreport

GE Healthcare invests $1bn in cancer diagnosis

by emma 19. September 2011 16:22

MB medtech news

UK-based corporation GE Healthcare has committed $1 billion over the next five years to developing molecular technologies for cancer diagnosis and imaging.

The investment will affect all regions of GE Healthcare’s global business and reflects the growing importance of molecular diagnostics in supporting targeted and personalised cancer therapies.

In the last seven years, GE Healthcare has strengthened its presence in the oncology field through its acquisition of seven specialist companies, including Clarient in 2010.

John Dineen, GE Healthcare’s President and CEO, said: “As one of the most relevant global cancer diagnostic companies, we are devoting an even greater share of our R&D budget to continue developing new oncology solutions.

“With a disease as complex and multifaceted as cancer, solutions need to be equally multifaceted and even more integrated, combining imaging, molecular diagnostics and healthcare IT.”

“The only way we can help clinicians beat cancer is to give them the tools to find it earlier, stage it better, and quantitatively measure response to therapy,” added Mike Harsh, GE Healthcare’s Chief Technology Officer.

“The integration of GE Healthcare’s expertise in imaging, analytics, diagnostics, cellular analysis, and healthcare IT is helping create technologies and solutions that can be used in a rural developing country or in a modern urban hospital.”

The investment will focus on such new solutions as:

  • A new biomarker for molecular diagnostic tests for breast cancer, lung cancer and ovarian cancer, developed by GE’s Clarient business and planned for market launch in 2013.
  • A new ‘multiplexing’ technology that could allow pathologists to conduct more than 50 different stains on a single tissue section, enabling more effective personalised treatment recommendations.
  • New agents for real-time metabolic imaging based on GE’s C13 technology for tracking tumour growth and response to treatment.
  • A new system for connected oncology workflow, MD Connect, which enables access via any networked computer to the complete suite of oncology applications from any location or department. MD Connect integrates with the Eclipse treatment planning platform from Varian Medical Systems.

Based in Chalfont St. Giles, GE Healthcare is a global leader in the development of transformational medical technologies and services focused on reducing costs and increasing patient access.

NHS to promote early diagnosis of bowel cancer

by Emma 19. September 2011 12:40

The first ever national campaign to raise awareness of bowel cancer will be launched by the Department of Health in January 2012.

‘Be Clear on Cancer’ is part of an £8.5 million package to promote and develop bowel cancer screening and treatment services.

The awareness campaign, which follows successful regional trials, aims to encourage the public to be aware of possible early symptoms of bowel cancer and discuss these with their GP.

Other measures aimed at improving bowel cancer survival rates include:

  • extending the screening age to 75
  • introducing flexible sigmoidoscopy screening at 55
  • promoting laparoscopic colorectal surgery
  • training for lower rectal surgery.

Regional pilots for the awareness campaign in the South West and East of England led to a 48% increase in the number of people reporting symptoms to their GPs and a 32% increase in urgent referrals to hospitals.

“No-one likes thinking about cancer, or talking about their poo. But the plain fact is no-one dies of embarrassment,” said Health Minister Paul Burstow. “Early diagnosis makes a huge difference to your chance of survival.”

The new campaign is part of the National Awareness and Early Diagnosis Initiative, set up by Cancer Research UK and the DH. Harpal Kumar, Chief Executive of Cancer Research UK, commented: “The key reason our cancer survival lags behind the best in the world is that we diagnose the disease late.”

In a joint statement, charities Bowel Cancer UK and Beating Bowel Cancer noted: “We know 90% of people will survive if diagnosed at the earliest stage of the disease. The tragedy however is that only 9% are. Worryingly awareness of symptoms and the disease is still way too low. We hope this campaign will help change that.”

The DH is also launching a new regional campaign in October to raise awareness of the early symptoms of lung cancer across the Midlands.

Campaign for faster drug testing

by emma 19. September 2011 09:52

MB Market news

A new campaign for the introduction of rapid drug testing after road accidents is being supported by a leading UK supplier of devices for rapid testing.

Concateno, formed by the merger of seven UK drug and alcohol testing specialists, is assisting the campaign for a law that would allow roadside drug testing of motorists involved in accidents.

A similar programme introduced in Australia has halved the incidence of driving under the influence of illegal drugs.

The company’s hand-held drug testing device, the DDS, can analyse a sample of oral fluids for six illegal drugs in five minutes. It won a Queen’s Award for Innovation in 2010.

The legislation demanded by the campaign has been named ‘Lillian’s Law’ after teenager Lillian Groves, who was killed by a car whose driver had been smoking cannabis. The driver escaped a conviction for driving under the influence of drugs because he was tested nine hours later.

Roadside drug testing, using rapid diagnostic tests of saliva, has been applied in several countries including Australia, Spain, Germany and Italy. In Victoria, Australia, it has seen the number of people driving under the influence of illegal drugs fall in five years from one in 44 to one in 94.

“In Australia, the use of roadside drug testing technology has proved extremely successful and has certainly helped to make our roads safer,” said Victoria’s Police Inspector, Martin Boorman.

Concateno spokesperson Iain Forcer commented: “Police in the UK are not allowed to use these devices that can quickly test drivers for drug use. Instead, they are required to carry out a lengthy Field Impairment Test which can take up to 30 minutes to complete, and few police officers are qualified to carry out these FIT assessments.”

This autumn, Concateno will attend two major UK conferences on transport security and traffic policing, as well the European DRUID conference on industry and innovation.

Concateno is a subsidiary of US company Alere, a specialist in rapid diagnostics.

FDA approves ovarian cancer diagnostic

by emma 16. September 2011 16:05

MB product news

The FDA has approved Fujirebio Diagnostics’ combination blood test to detect ovarian cancer in women with ovarian cysts.

The test combines measures of two biomarker proteins, HE4 and CA125, using an algorithm called ROMA, aiming to improve physicians’ ability to identify ovarian cancer in women suffering from an ovarian cyst or mass.

The combined method shows the highest accuracy in determining ovarian cancer risk in premenopausal and postmenopausal women and “will change the way doctors diagnose and treat ovarian cancer”, claims Dr Richard G Moore, lead developer of the test and ROMA, gynaecologic oncologist at the Women & Infants Hospital of Rhode Island and Director of the Center for Biomarkers and Emerging Technology.

The new equipment enables physicians to be specific in choosing how the patient should be treated.

Dr Moore said: “Having women triaged to the right surgeons is very important. It gives them a survival advantage.”

“Patients who have ovarian cancer have better outcomes when their surgery is performed by a gynaecologic oncologist at centres experienced in the management of this disease,” he added.

Until now, the CA125 test has been the best method for monitoring patients with ovarian cancer. But the test is limited in its sensitivity and accuracy as well as its ability to detect every type of ovarian cancer. The HE4 protein has been shown to be higher in epithelial ovarian cancers, which is the most common type of ovarian cancer.

Combining these techniques with the ROMA algorithm enables the physician to differentiate between benign diseases and ovarian cancer in women who experience a pelvic mass.

Paul Touhey, President and CEO of Fujirebio Diagnostics, commented: “The ROMA test, by improving the sensitivity and specificity of methods to stratify patients with ovarian cancer, is expected to help thousands of women determine their risk for ovarian cancer and enable those who are at risk to be referred to a gynaecologic oncologist – a benefit that may improve treatment outcomes.”

“With this increased ability to improve referral patterns, as well as a price that is comparable to CA125 testing, the health care costs involved with cancer diagnosis and treatment should decrease significantly.”

Telehealth market set for rapid growth

by emma 16. September 2011 15:19

MB Market news

The global market for telehealth services will pass $1 billion by 2016, a new business report has claimed.

In the 2011 edition of its report The World Market for Telehealth, medical electronics market research group InMedica forecasts that the telehealth market could reach $6 billion by 2020.

The report highlights the growing use of home monitoring systems to monitor vital signs, improving the control of long-term conditions such as diabetes, heart failure and COPD.

The leading market for telehealth systems is the US, the report notes, but there have been some large-scale trials in Europe – most notably in the UK, where more than 2,000 patients have received telehealth services.

“Many public healthcare systems now have targets to reduce both the number of hospital visits and the length of stay in hospital,” said Diane Wilkinson, Research Manager at InMedica. “This has led to a growing trend for healthcare to be managed outside the traditional hospital environment, and as a result, there is a growing trend for patients to be monitored in their home environment using telehealth technologies.

“What is apparent is the convergence of many different industries in this space, including telehealth companies, device manufacturers, healthcare agencies, service providers and telecommunication companies.”

The World Market for Telehealth – a Quantitative Market Assessment, 2011 Edition” provides an overview of the global telehealth market, analysing the sector’s business models, technologies, peripheral devices, major suppliers and market drivers/inhibitors.

InMedica is the medical research group of IMS Research, a leading supplier of market research and consultancy to the electronics industry.

Computer can detect pain, claims study

by emma 16. September 2011 13:28

MB Innovation news

A new computer learning software can detect when people are in pain, claims a new US study.

A team at Stanford University in California have claimed that data gathered from brain scans can teach the computer through patterns of brain activity to determine whether or not someone was experiencing pain with 80% accuracy.

Doctors currently rely on patients communicating their symptoms, which can be unreliable, or in some cases impossible, regarding the very young, very old, or those who are unconscious.

Dr Sean Mackey, head of the study, said: “People have been looking for a pain detector for a very long time”.

For the study, eight volunteers underwent brain scans whilst touching hot objects, and hotter objects that were painful to touch.

The computer, which used linear support vector machinery – algorithms invented in 1995 – used the data to recognise the differences in patterns of brain activity.

“We're hopeful we can eventually use this technology for better detection and better treatment of chronic pain.”

Blueprint for a healthy nation?

by emma 16. September 2011 09:44

71085146

The revised Health and Social Care Bill remains contentious, but appears likely to pass into legislation. Simone Carron-Peters of Frost & Sullivan analyses its probable impact on the UK healthcare market.

The Government’s contentious Health and Social Care Bill has raised many concerns among the various stakeholders. The eight-week NHS listening exercise conducted by the NHS Future Forum has resulted in the proposal of multiple changes to the Bill, whose passage towards legislation is summarised in Figure 1 below.

This article evaluates the planned NHS reforms for impact on the health system and the life science industry.

figure1blueprinthealthynation

Overview of the Bill

The Health and Social Care Bill proposes to create an independent NHS Board, promote patient choice and reduce NHS administration costs.
Its key focus areas are:

  • To establish an independent NHS Board to allocate resources and provide commissioning guidance.
  • To increase GPs’ powers to commission services on behalf of their patients.
  • To strengthen the role of the Care Quality Commission.
  • To develop Monitor, the body that currently regulates NHS Foundation Trusts, into an economic regulator to oversee aspects of access and competition in the NHS.
  • To reduce the number of health bodies, including abolishing PCTs and SHAs, in order to help the Government cut NHS administration costs by one-third.

More power (and money) to the GPs

In its initial form, the reform aimed to improve the quality of service delivery by devolving NHS commissioning powers and responsibility into the hands of GPs. The GP consortia would receive budgetary allocations from the new NHS Commissioning Board, which would be responsible for managing and allocating about £80 billion of the health budget. The consortia would, in turn, devolve the funds to the various practices under them.

The new GP consortia would replace the 302 PCTs in England, which would be abolished by 2013. All NHS trusts were set to become Foundation Trusts by April 2014. It was anticipated that the consortia would require significant assistance, including support from the private sector, in exercising these new commissioning functions.

Medical organisations and NHS trusts were immediately sceptical about the implementation of this reform, saying that the changes could have negative effects on NHS services. Some trusts argued that it is risky to reduce the central grip on commissioning at a time where urgent savings are being made. Others agreed that GPs are well positioned to make decisions on the use of resources for their patients.

The BMA: a critical response

The reform plans have also not gone down well with the British Medical Association (BMA), who expressed concerns about the level of responsibility being bestowed on GPs. One of the BMA’s major concerns was the lack of clarity in the Bill with regard to the roles that the GP consortia would be expected to perform. The BMA also believes that it is important to ensure the funding for GP practices remains distinct from other budgets, as it would cause significant complications if GP consortia were to be made responsible for amalgamated budgets that included the management of standard GP contracts.

Currently there are about 177 GP ‘pathfinders’ (pilot groups of GPs testing the system’s concepts and functions) who are taking the lead in implementing the new commissioning roles.

In May 2011, the BMA’s Health Policy and Research unit conducted a national survey of GP opinion that received a response rate of 39%. The survey findings revealed an alarming 55.8% of the respondents citing NHS reforms as a reason for their intention to retire in the next two years. That figure was composed of 59.4% of the 688 principal or contracted GPs, 41.1% of the 30 employed salaried GPs and 35.8% of the 39 freelance GPs who participated in the survey.

The survey also asked GPs how confident they were that the GP commissioning consortia would be appropriately skilled and supported. 65.6% were ‘not confident’ that the consortia would be appropriately skilled, while only 15.8% were ‘confident’ that they would be. In addition, 70.9% of the respondents stated that they were ‘not confident’ that the consortia would be supported, while just 10.2% were ‘confident’ that they would be.

Amendments to the Bill

Based on the recommendations of the NHS Future Forum, the Health Secretary announced changes to the Health and Social Care Bill in June 2011. The Bill is due for its third reading on the 6th and 7th September 2011.

The role and functions of GP consortia are now better-defined. The consortia – now called Clinical Commissioning Groups (CCGs) – would be required to publish details on their constitution and how the allocated budgets have been used. They would also be required to follow guidelines from, and be accountable, to the NHS Commissioning Board. GPs are also bestowed with a responsibility to promote research and innovation.

The plan for all NHS trusts to become Foundation Trusts by April 2014 has been amended. NHS trusts would become Foundation Trusts by 2016, based on their clinical readiness for transition. They would be given the liberty to make use of private health treatments, and would compete among themselves for patients.

The role of the National Institute for Health and Clinical Effectiveness (NICE) would increasingly focus on giving authoritative advice to clinicians on when and how the most effective treatments can best be used, and also on the development of quality standards for the NHS to aim for in the treatment of certain conditions.

Value-based pricing (VBP) would replace the Pharmaceutical Price Regulation Scheme (PPRS), which has existed since 1957. The purpose of VBP is to improve NHS patients’ and clinicians’ access to effective and innovative drugs and medical technologies by ensuring they are available at a price that reflects their value, based on an assessment of the outcomes they can achieve.

Impact assessment of the health reforms

The implementation of the Health and Social Care Bill will witness an increase in private sector and voluntary involvement in the delivery of healthcare. GP commissioning will allow the use of private healthcare for NHS patients. Healthcare vendors and providers can capitalise on this shift by offering products and services best suited to patients’ needs in order to influence GP commissioning.

The aim of value-based pricing is not to achieve the lowest price possible, but to encourage the development of new therapies and promote innovation. The principle of linking the price of innovations to their value has already received support from a broad range of stakeholders.

The priorities of the health reforms are ambitious; if instituted, they will have far-reaching effects on the way the British public accesses the health system. It will also affect the role of the private sector in the UK healthcare system, increasing opportunities for private providers of both clinical and support services to become involved in providing healthcare to NHS patients.

According to the Government’s calculations, the reforms will bring about a huge cost saving for the NHS. However, negative consequences such as redundancy for administrative staff in the health authorities will pose a huge socio-economic threat.

How will the savings affect the prospects for innovative medical technologies? The adoption of such products has always been necessary for medical professionals, predominantly because new technology aims to provide healthcare at a quicker rate – minimally invasive technologies being a major example. The Government has vowed to ensure the system delivers effective and appropriate healthcare to all who need it. Moreover, GPs have a greater understanding of patients’ needs than the managers or PCTs who at present make funding decisions. Thus the demand for innovative devices will arise regardless of the allocated NHS budgets.

One of the main objectives of the reforms is to put patients and public first by implementing a ‘no decision about me without me’ policy. National standards and independent inspection will continue to assure patients that all NHS-funded services are safe and of a high quality. Patients will have much more information about individual services and their performance, enabling them to choose the services that best meet their needs.

The reforms will ensure that services are easier to access and more responsive. Shorter patient waiting times, one-stop clinics for diagnostics, and increased provision of healthcare in patients’ homes are some examples of services that are likely to develop in response to new incentives. Patients will be able to gain access to healthcare in new ways that are more flexible. This is likely to mean more services delivered in local communities, such as urgent, preventative and rehabilitative care, thus helping to avoid unnecessary hospital admissions. Better information will help patients to understand and make the best use of the options available.

The reforms will also support services to become more integrated. Improved information systems will play a key role, enabling healthcare providers to exchange clinical data more easily and so gain a complete view of the patient’s condition. Increasingly, there will be opportunities for patients to influence the pattern of services within their locality. Local practices will have incentives to provide locally-based health improvement and health protection services. Patients will be in a better position to manage their own health.

Financial goals

The Government is confident that the health reforms will allow it to save billions. Figures from the Impact Assessment published alongside the Health and Social Care Bill earlier this year claim that the structural reforms to the NHS will save £5 billion per year, though this is a gross rather than net figure. The Bill promises to reduce NHS administrative costs while promoting patient choice. However, time alone will tell whether these reforms prove to be economic.

simone carron peters1 


Simone Carron-Peters is a Research Analyst for growth consultants Frost & Sullivan.

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