Final NICE diagnostic guidance on the EOS 2D/3D X-ray imaging system calls for the system’s health benefits to be further investigated in clinical research settings.

The new system (pictured) from US company EOS Imaging uses low-dose radiation imaging to produce 2D X-ray images and 3D reconstructions for bones.

Its innovative slot-scan technology, scanning a line at a time rather than taking the entire image at once, enables it to produce upright and weight-bearing whole-body images.

By showing relationships between the spine, hip, pelvis and knees, the EOS system could particularly benefit the monitoring and treatment of patients with spinal deformities or alignment problems.

The system’s reduced dose also offers potential safety advantages in the repeated imaging of patients with spinal deformities, especially children.

The new guidance encourages the use of the 2D/3D imaging system in specialist research settings to collect evidence about clinical benefits associated with weight-bearing whole-body imaging and 3D reconstruction.

Professor Carole Longson, Director of the NICE Health Technology Evaluation Centre, said: “The EOS 2D/3D imaging system was identified by the Diagnostics Advisory Committee as an important emerging technology. There is evidence showing comparable or better images and radiation dose reduction associated with using the EOS system to image patients with spinal deformities.”

However, she said, there is currently no evidence that compares the diagnostic accuracy of the EOS system with that of conventional radiological examinations. “NICE will follow up the Diagnostics Advisory Committee’s research recommendations on the EOS 2D/3D system and will assess the feasibility of this research with a view to facilitating the development of further relevant evidence.”

Full data sets evaluating the system’s benefits will trace the outcome of its use from planning through to complex surgeries such as hip replacements.

Marie Meynadier, CEO of EOS Imaging, said: “The EOS 2D/3D imaging system is subject to an extensive programme of research associating radiologists and orthopaedic surgeons. We will provide data to NICE as they are established to determine when a cost-effectiveness review based on this evidence would be appropriate.”

The new external assessment centres recently announced by NICE will help to develop and facilitate research products to assist suppliers when NICE medical technology or diagnostics guidance recommends it.

US-based Medtronic Spinal has launched a new type of spinal fusion surgery.

The MAST MIDLF procedure, announced to the North American Spine Society in Chicago, enables minimally invasive spinal fusion.

Described as a midline laminectomy, the procedure accesses the spine in the middle lower back, removing the need for the surgeon to work through a tubular retractor.

Over 250,000 people in the US undergo spinal fusions each year to treat degeneration of the lumbar spine.

“This surgical strategy enables a highly efficient, minimally invasive lumbar fusion, while allowing visualisation of familiar posterior landmarks,” said Dr. Richard Hynes, spine surgeon at The B.A.C.K. Center in Melbourne, Florida.

“A midline approach offers surgeons a number of benefits in addressing the challenges associated with decompression as well as sacral fixation in the lumbar or lower spine.”

The MAST MIDLFTM procedure can be used with Medtronic’s surgical navigation and imaging systems, improving the accuracy of device placement and reducing clinician exposure to radiation.

The new surgical procedure is the latest addition to Medtronic Spinal’s minimally invasive MAST portfolio of surgical treatments for degenerative and deformity-based spinal conditions.

Medtronic's spinal business, based in Tennessee, is a global leader in the treatment of spinal conditions.

University College Hospital (UCH), London has purchased the UK’s first Biograph mMR hybrid molecular MR system (pictured) from Siemens Healthcare.

In the same month, the hospital’s Institute of Nuclear Medicine brought together clinical scientists to celebrate its 50^th anniversary.

The Biograph mMR – one of the first to be installed in Europe – will be housed in the UCH Macmillan Cancer Centre and used for diagnosis and planning of patient treatment, as well as research.

The world’s first simultaneous whole-body PET-MRI scanner. the Biograph mMR has won the red dot design award 2011 and the Frost & Sullivan Best Practices Award 2011 for its integrated design and scanning capabilities.

At the Institute of Nuclear Medicine’s 50th anniversary, Bruce Rosen, Professor of Radiology, Health Sciences and Technology at Harvard Medical School, gave a lecture on the future of combined PET and MR.

UCH Chairman Richard Murley thanked the UCLH Charity for funding the purchase of the new scanner.

Professor Peter Ell, former Head of the Institute of Nuclear Medicine, summed up half a century of medical imaging, including the first European nuclear medicine brain scanner in the 1970s; the first dedicated mobile renal function apparatus in the 1980s; and the introduction of PET-CT in cancer management.

France is Europe’s biggest importer and exporter of medical devices. However, current reforms are driving cost reduction and efficiencies. Medtech Business in association with Espicom takes a look at the French market for medical technologies.

France is one of the top five medical device markets in the world, accounting for around 3.9% of the global market.* Within Europe, the market ranks behind Germany and is a similar size to that of the UK.

The country has a well-developed healthcare system, combining public hospitals with commercial clinics that are the main providers of elective surgical treatment. While the public sector is the largest purchaser of most diagnostic and therapeutic equipment, the private sector is the dominant purchaser of surgical equipment and supplies.

The high level of healthcare expenditure (11.8% of GDP) and the substantial health deficit are major concerns that have prompted various reform programmes aimed at curtailing costs and improving efficiency in the healthcare system. For this reason, the medical market is only likely to see moderate growth, rising from US$8.3 billion in 2011 to US$9.8 billion by 2016.

Despite several high-profile investment programmes, France continues to lag behind its European neighbours in some high-technology fields, most notably imaging and radiotherapy equipment. A second five-year cancer plan has now been launched which aims to increase the numbers of scanners.

With flagging domestic production in several sectors the French medical device market is increasingly reliant upon imports, which now account for around 80% of consumption. However, many imported products are re-exported to other countries.

 

The market in 2011

In 2011, the French medical device market (see Figure 1) is valued at US$8,280 million. Consumables is the largest product category, accounting for 20.9% of the overall market, followed by diagnostic imaging (19.8%).

Espicom estimates that the medical device market will grow at an average annual growth rate of 3.5% between 2011 and 2016 – bringing the total market value to US$9.8 billion by 2016.

Orthopaedic and prosthetic devices are expected to continue to be the most dynamic sector of the market, with growth forecast to be more than double the rate for the overall market. Conversely, diagnostic imaging is forecast to have the lowest growth during the 2011–16 period.

 

Predictions for market segments

Figure 2 shows Espicom’s predictions for the major segments of the medical device market.

1. Consumables. The market for medical consumables is estimated at US$1,729 million. The consumables market grew at an annual rate of 5.1% in US dollar terms between 2006 and 2010. Imports supply the greater part of the market. Espicom estimates the consumables market will continue to grow by an average of 3.5% over the next few years.

The wound care products market is forecast to grow at an average annual rate of 2.9% in US dollar terms during the 2011–16 period. Syringes, needles & catheters has been the fastest growing sector of the consumables market and will continue to be, with a CAGR of 4.1% to 2016.

2. Diagnostic imaging apparatus. The market for diagnostic imaging is estimated at US$1,636 million. The market grew at an annual rate of 2.8% between 2006 and 2010. France lags behind its European neighbours in the diagnostic imaging field, though the second cancer plan aims to increase provision of MRI, CT and PET scanners.

Imports supply the greater part of the market, though their market share is lower for radiation apparatus due to the strength of the domestic manufacturing industry. The USA and Germany are the major sources of supply. Espicom estimates that the imaging market will grow by an average of 2.1% between 2011 and 2016.

3. Dental products. The market for dental products is estimated at US$859 million, equal to 10.4% of the total medical device market. The dental products market grew at an annual rate of 4.2% between 2006 and 2010. It is forecast to grow at an annual rate of 3.5% over the next few years, taking the total to US$1,020 million by 2016.

4. Orthopaedic & prosthetic devices. The market for orthopaedic & prosthetic devices is estimated at US$1,336 million, equal to 16.1% of the total medical device market. The orthopaedic & prosthetic devices market grew at an annual rate of 9.2% between 2006 and 2010.

Imports have seen particularly high growth in recent years, though a corresponding increase in exports in this sector indicates that not all imported products are destined for the domestic market. The majority of orthopaedic imports are supplied by Switzerland and the USA.

The orthopaedic & prosthetic devices market is forecast to grow at an annual rate of 6.1% in US dollars over the next few years, taking the total to US$1,794 million by 2016.

5. Patient aids. The market for patient aids is estimated at US$1,131 million, equal to 13.7% of the total medical device market. The patient aids market grew at an annual rate of 4.5% between 2006 and 2010.

French imports of patient aids far exceed the value of the domestic market due to a high level of re-export activity, particularly for pacemakers. Switzerland and the USA are the leading suppliers of portable aids, whilst the USA and China are the major sources of supply for therapeutic appliances.

The patient aids market is forecast to grow at an annual rate of 3.9% over the next few years, taking the total to US$1,367 million by 2016.

 

Imports

The value of French medical device imports has recorded a steady rise over the past decade, reaching US$10.4 billion in 2008 before falling back to US$10.3 billion in 2009.

Imports of consumable items amounted to US$1,780.6 million in 2009. Imports fell by 1.0% over 2008 in US dollar terms (though they increased in euro terms). Syringes, needles, catheters & cannulae are the largest subcategory.

Diagnostic imaging imports totalled US$1,564.0 million in 2009, equal to 15.2% of the total. This was the weakest performing category in 2009, with a fall of 16.4%.

Imports of orthopaedic & prosthetic devices were worth US$1,549.1 million in 2009, equal to 15.1% of total medical device imports. This was the fastest growing category in 2009, with a rise of 26.6%. All three subcategories – artificial joints, orthopaedic appliances and other artificial body parts – recorded strong growth.

Patient aids are the largest import category, with imports worth US$2,624.1 million in 2009, equal to 25.5% of total medical device imports. Pacemakers accounted for 54.7% of imports in this category in 2009, but also accounted for more than half of patient aid exports.

The leading suppliers of French medical imports in 2009 were the USA, Switzerland and Belgium, with the UK ranking eighth as a supplier with imports worth US$288,964 (2.8% of the total).

 

Exports

In 2009, medical device exports registered a 3.0% fall in value to US$9.2 billion, having recorded steady growth in previous years with a CAGR of 6.8% for the 2005–2009 period.

In 2009, 69.5% of all French medical device exports were sent to the rest of the EU, with the Netherlands taking a 17.6% share, followed by Germany with 14.4%. The UK took 6.6% of French medical device exports.

Outside Europe, the leading destination is the USA, which accounted for 9.1% of exports. The USA is the leading destination for French exports of diagnostic imaging apparatus.

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

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 66 markets covered, please visit www.espicom.com/outlookm1

A new fluorescent imaging agent to assist detection of papillary cancer of the bladder has been adopted by Thomas Jefferson University Hospital in the USA.

Cysview (known in Europe as Hexvix) is licensed by GE Healthcare from Norwegian company Photocure ASA.

Used with patients who are known or suspected to have bladder cancer, it guides blue light fluorescence cytoscopy (pictured), which highlights cancerous lesions in the bladder.

The use of Cysview for cytoscopy has been shown to improve surgical outcomes relative to standard white light cytoscopy alone.

Bladder cancer, most commonly caused by smoking, is the fourth most common type of cancer in men and the eighth most common in women.

“Bladder cancer is difficult to detect,” said Dr Leonard Gomella, Associate Director for Clinical Affairs at the Kimmel Cancer Center at Thomas Jefferson University Hospital. “A missed diagnosis can result in delayed or incomplete treatment, which may lead to serious complications and a lower chance of survival.

“Cysview represents an important advance in diagnostic technology, enabling more accurate diagnosis of bladder tumours compared to the standard technique. By facilitating early diagnosis of bladder cancer, this innovative imaging agent can enable appropriate, timely treatment that may improve patients’ chances of survival.”

Hologic, a manufacturer of diagnostics, surgical products and medical imaging technology for women, has received FDA clearance for its Trident specimen radiography system.

The device uses the company’s proprietary direct digital detector technology to produce high quality images of tissue samples, aiming to reduce procedure steps, streamline workflow and increase accuracy.

Peter Soltani, Senior Vice President and General Manager for Breast Health, said: “Our goal is to provide leading-edge technologies that improve the diagnostic precision of procedures and create a better experience for patients and their healthcare providers.”

The Trident is designed for use in the operating room where breast tissue is surgically excised, and in biopsy suites where minimally-invasive breast biopsies are performed.

Based in Massachusetts, USA, Hologic is a developer, manufacturer and supplier of diagnostics, medical imaging systems and surgical products dedicated to the healthcare needs of women with a focus on breast health, diagnostics, GYN surgical, and skeletal health.

Mobisante has launched its MobiUS SP1 in the US, the world’s first smartphone-based ultrasound imaging system.

The device joins other portable point-of-care diagnostics that have recently entered the mobile health sector, including GE’s handheld visualisation tool Vscan and Siemens' Acuson P10.

The £4,700 MobiUS SP1 is designed for use in foetal, cardiac, pelvic, paediatric, musculoskeletal, peripheral vessel and abdominal imaging, providing the potential for enhanced patient care in any location, even remote areas.

The mobile health technology uses both cellular and WiFi networks, and consists of a Windows Mobile 6.5-based Toshiba TG01 smartphone, an ultrasound probe and computer software.

The manufacturer claims that the system could also be more suitable for use in low-income regions than traditional ultrasound equipment due to its lower operating costs and the increased convenience it would provide for patients.

Mobisante actually received FDA clearance for the device in February 2011, but it took eight months to implement necessary FDA-mandated controls.

The company is exploring the option of making a version of the product for healthcare-specific tablet computers as well.

Canon has received FDA clearance for its CR-2 Plus Digital Non-Mydriatic Retinal camera for use in eye diagnostic imaging.

Tsuneo Imai, Senior Director and General Manager of the Medical Systems Division at Canon USA, said that the approval “brings Canon one step closer to improving eye exam efficiency and eventually leading to the early prevention and treatment of vision threatening diseases”.

The medical device features EOS camera technology using 18 megapixels with low-flash intensity, minimising pupil constriction while shortening the time required for taking multiple pictures.

The product’s use of Canon’s Retinal Imaging Control Software (RICS) allows images to be captured, processed and sent to be stored or printed.

Wearers of implanted cardiac devices such as pacemakers (pictured) and defibrillators can safely undergo Magnetic Resonance Imaging (MRI) scans, according to a report by cardiologists at Johns Hopkins Hospital, USA.

The report outlined a protocol for safe MRI scans based on device selection, programming and careful patient monitoring.

MRI scans, which are important for the diagnosis and monitoring of tumours and other soft tissue pathologies, have traditionally been considered too dangerous for people with implanted devices.

Saman Nazarian, cardiac electrophysiologist, said: “The guidelines we have published can be used to make MRI more available to people who could benefit from early detection of cancer and other diseases and for guiding surgeons during procedures.”

The study followed 438 people with implanted cardiac devices. With appropriate precautions, the researchers found, patients with pacemakers and defibrillators can undergo an MRI scan with very low risk of the device malfunctioning, moving or heating.

The protocol, developed over 15 years by cardiac electrophysiologist and biomedical engineer Henry Halperin, includes:

• Checking the age of the device – pacemakers made after 1998 and defibrillators made after 2000 have electromagnetic interference protection.
• Checking the type and configuration of the leads – e.g. if a lead is disconnected and not part of the device’s function, an MRI is not safe.
• Reprogramming the device to a safe mode during the scan.
• Monitoring the patient's blood pressure, oxygen saturation and electrical activity of the heart, and looking for any unusual symptoms.
• Checking and reprogramming the device after the scan.
• A follow-up check after 3–6 months.

“With the advancing age of the population and the expanding indications for pacemakers and defibrillators, this has become an increasingly important issue, and a lifesaving one for some patients,” commented Nazarian.

A new, hi-tech retinal imaging system that could help millions of diabetes patients from going blind has been launched in Europe.

EasyScan, developed by eye diagnostics specialist, i-Optics, is easy-to-use and more portable than systems currently used in retinal imaging.

The device aims to diagnose and treat diabetes patients quicker to prevent blindness earlier.

As pupil dilation is not required for diagnosis, the device reduces patients’ waiting times by at least 30 minutes. Patients can also drive immediately after examination.

Jereon Cammeraat, CEO at iOptics, said: “With aging populations and growing obesity, countries everywhere face a rapid increase in diabetic retinopathy, age-related macular degeneration, glaucoma, and other retinal diseases.”

He said that the current technology featuring fundus cameras are “large, exclusive, and expensive, as well as being slow and difficult to use”.

EasyScan’s non-invasive technology consumes little energy and can connect to a PC or laptop via a USB port. Using Scanning Laser Ophthalmoscope (SLO) technology, the device can identify clinical features in the retina in the earliest stages, provide better contrast than traditional fundus cameras, and can better penetrate media opacities such as cataract and corneal opacities.

i-Optics is a worldwide eye imaging developer, aiming to develop affordable, quick retinal diagnosis solutions.