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Take a look at a selection of our recent media coverage:

FDA advisory panel votes favourably on the Boston Scientific WATCHMAN™

13th December 2013

The US Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted favourably by a majority, Yes: 13, No: 1, that the benefits of the WATCHMAN Left Atrial Appendage Closure device outweigh the risks. The FDA Panel was further asked if there is reasonable assurance that the device is safe, the Panel voted Yes: 13, No: 1. On the question of reasonable assurance of efficacy, the Panel voted Yes: 13, No: 1. The FDA will take into account the Panel’s vote in its decision on approval of the WATCHMAN device. The company expects a decision from the FDA in the first half of 2014.
“We are pleased with the outcome of today’s Panel, which represents an important milestone toward making this innovative technology available to patients with AF at higher risk for stroke who need an alternative to long-term warfarin therapy,” said Kenneth Stein, MD, Chief Medical Officer, Cardiac Rhythm Management, Boston Scientific. “We appreciate the opportunity to present our comprehensive data supporting the WATCHMAN technology and look forward to continuing discussions with the FDA regarding the Panel’s comments.”
The vote of the committee followed a review of clinical data from two randomised control trials, PROTECT AF and PREVAIL, as well as from the CAP (Continued Access Protocol) registry. WATCHMAN is the most studied left atrial appendage closure device and the only one with long-term clinical data from 2,000 patients and with almost 4,900 patient-years of follow-up in clinical trials. The WATCHMAN device received CE Mark in 2005. In the United States, WATCHMAN is an investigational device, limited to investigational use and not available for sale.
About atrial fibrillation and stroke
Atrial fibrillation (AF) is an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications. AF is the most common cardiac arrhythmia, currently affecting more than five million Americans.(1) Patients with AF have a five-fold increased risk of stroke due to blood stagnating from the improperly beating atrium and the resulting blood clot formation.(2) Twenty percent of all strokes occur in patients with AF.(3) Stroke is more severe for patients with AF, as they have a seventy percent chance of death or permanent disability.(2) The most common treatment for stroke prevention in patients with AF is blood-thinning warfarin therapy. Despite its proven efficacy, long-term warfarin therapy is not well-tolerated by some patients and carries a significant risk for bleeding complications.
About the WATCHMAN device
The WATCHMAN device is a catheter-delivered heart implant designed to close the left atrial appendage (LAA) in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF.
The LAA is a thin, sack-like appendix arising from the heart and is believed to be the source of a majority of stroke-causing blood clots in people with AF.(4) The WATCHMAN device is commercially available in more than 55 countries, and over 7,000 implants have been performed worldwide. The device was developed by Atritech, which Boston Scientific acquired in March 2011. Images of the WATCHMAN device are available at
References
  1. Colilla et al., Am J Cardiol. 2013; 112:1142-1147
  2. Holmes DR, Seminars in Neurology 2010; 30:528–536
  3. Hart RG, Halperin JL., Ann Intern Med. 1999; 131:688–695
  4. Blackshear J. and Odell J., Annals of Thoracic Surgery. 1996; 61:755-759

New white paper details structural changes facing healthcare industry

11th December 2013

A new white paper, ‘The Resilience Imperative: Reinventing healthcare supply chains’, commissioned by DHL, the world’s leading logistics company, argues global life sciences and healthcare (LSH) companies must reevaluate and revolutionise their approach to their supply chain management in order to survive the unprecedented myriad of challenges threatening major disruption to the industry.
 
This thought leadership paper identifies a number of key trends which could derail the industry’s logistics such as emerging market growth, burgeoning regulatory and compliance requirements, changing product characteristics, and rocketing counterfeit drug trafficking. Moreover, shrinking margins, escalating cost pressures and growing consumerism are transforming the business paradigm. What is emerging is a business model that looks and acts like the consumer goods industry, where the customer – not the manufacturer – holds the power.
 
Lisa Harrington, President of the lharrington group LLC, prepared the report in collaboration with DHL to identify the challenges and developments affecting the sector globally. Harrington is also Associate Director of the Supply Chain Management Center and lecturer of supply chain management at the Robert H. Smith School of Business, University of Maryland.
 
She says, “The stakes in the new normal of LSH are enormous. So large, in fact, that the U.S. Congress was willing to shut down the entire US federal government for two weeks while it fought over healthcare reform issues. That shutdown, according to Standard and Poor’s, cost the US economy more than $24 billion.
 
“The LSH sector finds itself in the position of needing to rethink its entire economic model, and find ways to reduce costs across the board, in order to maintain share in a marketplace that is no longer willing, or able, to fund previous pricing.
 
“The old LSH supply chain model is no longer fit for purpose. The new LSH environment requires a more resilient, adaptive supply chain model that delivers robust global management capabilities, reduces costs and hard-wires the agility, flexibility and resiliency needed to support the challenges of global health.”
 
For most industries, experiencing two or three complex challenges at one time is enough to cause turbulence. But the LSH sector is contending with a complex web of issues which amount to the end of business as usual and call for a corresponding change in supply chain management:
 
Patent cliff, changing products and profit erosion: In 2012, $38bn of sales was lost due to patent expiration on major drugs moving to generics, while the global austerity of from value-driven governments, commissioning bodies and private payers worldwide has contributed to prescription sales falling by 1.6% to $714 billion.
A highly cost-effective supply chain that also delivers fast, reliable speed is required to meet the needs of an increasingly empowered, consumer-led market. Meanwhile, higher value products that are better protected from sales erosion carry significant financial risk if mismanaged in the supply chain.
These include biological pharmaceuticals focused on unmet medical needs or medical devices with proven clinical benefits which have complex ranges, temperature requirements and final destinations (including hospitals and to home).
 
Emerging markets, demographic shifts and healthcare policy: The world’s population is ageing with over 60s expected to be more than 1/3 by 2050. In addition, emerging markets such as Brazil, Russia, India, China and Mexico and their growing middle-classes represent a significant growth opportunity for LSH companies.
To adapt, LSH companies must adopt business models which allow for geographical range and therefore require tailored supply chains that deliver a higher volume of goods to increasingly diverse end points such as hospitals and distributed care in the home.
 
Regulations, compliance and product integrity: The growing issue of counterfeits has led to regulators enforcing stringent and diverse product integrity control. Intensified security and data collection adds pressure throughout the supply chain, as rigorous serialisation is required at distribution touch point, often painstakingly at the unit rather than lot level.
 
Jonathan Blamey, VP LSH, DHL Supply Chain, says, “Providing life-saving products is a big responsibility, one with risks that far outweigh those in a typical supply chain environment. LSH companies have to configure their business for each market, meeting the regulatory requirements and operational constraints of each healthcare system. Add in manufacturing constraints, compliance, temperature control and other factors, and you get a highly complex supply chain.
 
“To capitalise on growth opportunities and prosper in this environment, there is a tremendous opportunity and pressing need for LSH companies to take learnings from other supply chain models such as the automotive and FMCG industries. We understand the challenges facing LSH companies and have created solutions that help our customers to meet today’s challenges and anticipate tomorrow’s.”
 
DHL Supply Chain has expanded its global network of LSH services by over 25% in 2013 with the addition of 30 new warehouses, of which 12 are in emerging markets. It now operates over 150 facilities comprising over 2 million square metres of warehousing space and 1.9 million pallet locations dedicated to LSH, with over 4500 dedicated healthcare staff worldwide.
 
Download and view the full report at
www.dhl.com/lifesciences-resilience. For more information about supply chain best practice, solutions and success stories, visit the DHL Supply Chain LSH pages at www.dhl.co.uk/en/logistics/industry_sector_solutions/life_sciences_and_healthcare_logistics.html.

Evolva to participate in European research project

Evolva Holding SA (SIX: EVE) has announced that it will participate in the EU-funded PROMYS research project. The project has a duration of four years and a total EU funding of €7.2 million (CHF 8.9 million), of which Evolva’s share is 9.8%. The project is the latest of a series of EU collaborations that Evolva has been awarded with partners.
 
The PROMYS project is part of the European Commission’s 7th Framework Programme for Research (‘FP7’). The project’s goal is to implement a novel platform technology termed ligand responsive regulation and selection systems. This technology will be applied to deliver increased fermentation yields by continuously selecting for high yielding cell factories within a fermentation population. The other participants in the PROMYS project are the Technical University of Denmark and the universities of Darmstadt (Germany), Groningen (Netherlands) and Warwick (UK). Apart from Evolva, companies from Spain (Bacmine S.L.) and Denmark (Biosynthia ApS) are participating.
 
Evolva’s role in the project will be to construct a yeast  that is able to produce high yields of a taste modulating ingredient. The biosynthetic pathway to this ingredient will be used in other parts of the project. The ingredient is also commercially attractive in its own right. Apart from the grant received, Evolva will retain the right to commercialise the fermentation-derived product.
 
Neil Goldsmith, Evolva’s CEO, commented, “PROMYS clearly shows the European Union’s commitment to synthetic biology as an innovative, sustainable alternative production method. The fact that the PROMYS application came in 1st among 131 in the selection procedure, confirms the participants’ leading position in this space. We are looking forward to working with academia and corporates in this ground-breaking project.”
 
Evolva is involved in a number of collaborative research projects, partially funded by the EU or other institutions, and is highly committed to the generation and sharing of knowledge in our scientific area. In total, Evolva has dedicated some 5 FTEs to such projects, or close to 6% of the R&D staff. Additional information on the key projects is available on Evolva’s website.  

2013 automated image analysis adoption survey

10th December 2013

Definiens, a healthcare company that advances personalised medicine through image analysis and digital pathology solutions, today released results from an industry survey on the drivers of automated image analysis adoption and predictions on the future of digital pathology.
Findings showed that scientists and pathologists are adopting automated image analysis solutions primarily to obtain greater confidence in their data and to address the increasing volume of images that require detailed analyses. The use of image analysis in this manner is an enabler of tissue phenomics™, or the ability to quantify all relevant morphological features on a tissue slide.
The 2013 automated image analysis adoption survey conducted by Definiens was an anonymous electronic survey sent to scientists and pathologists in the pharmaceutical, biotech, and academic industries.  
“This survey confirmed that with the large number of digital tissue images being produced using whole slide image scanners, the need for automated image analysis is becoming much more prevalent. By using image analysis for the datafication of tissue, scientists and pathologists can achieve the confidence levels necessary to make critical decisions in drug discovery or biomarker development,” said Thomas Heydler, CEO of Definiens.
The study found the top four drivers of image analysis adoption, in order of importance, are:
  1. Gain greater confidence in data and conclusions. The decisions being made utilising digital images are highly important. They range from discovering potential targets for further study to go/no-go decisions on potential drug targets and biomarkers for companion diagnostics. Automated image analysis strengthens the confidence in results by establishing a set standard for measurement that scientists and pathologists can apply to all images in a study cohort.
  2. Address the volume of images requiring analysis. Digital image scanners enable the creation of hundreds to thousands of images in a record amount of time. Those images require analysis, and manually reviewing them can take a significant amount of time scientists and pathologists don’t have. Developing automated algorithms to independently analyse all images eliminates tedious work and while ensuring all information in the tissue can be utilised by the pathologist.
  3. Correlate image data with other data sources. Unlike manual analysis, where tissue image data is reduced to qualitative scores, automated image analysis enables the information in tissues to be turned into quantifiable, discrete data points. The tissue data output can be easily aligned and compared with data points from genomic analysis or patient outcomes to discover and develop disease biomarkers in ways single sources of data alone don’t allow.
  4. Quantify complex tissue features and morphology. Automated image analysis is not limited to single data points. Scientists and pathologists can now ask complex questions and develop algorithms that look at and quantify features and morphology the human eye can’t manage on a large scale.
To see a full summary of the survey results, including results on why users of digital pathology have not adopted image analysis, please visit the Definiens website:

Improve healthcare systems through the use of IT

9th December 2013

Following the launch of their CityNext initiative in the summer, Microsoft has recently launched an IDC Health Insights white paper that explores how cities across the world can implement sustainable health and improve their healthcare systems through the use of IT.
 
If it is of interest, in addition to sharing the white paper, I can also arrange for an interview with Neil Jordan, Worldwide General Manager for the Health Industry at Microsoft. Some of the topics that Neil could provide some insight on include:
 
  • Mobility in healthcare: how is data allowing healthcare professionals to change the way they deliver healthcare for example, secure data sharing through solutions like HER, ePrescription systems and Health Information Exchange Platforms
  • The current situation with EPR/EMR across Europe and globally, opportunities for medical professionals with EPR/EMR and how to maximise effectiveness
  • Health apps for healthcare professionals, helping them in their day to day jobs as they see patients and enabling collaboration with other care providers
  • Telehealth and the opportunities for personalised medicine and remote healthcare delivery
  • Delivery of patient centric services through relationship management solutions and automated follow up processes

Definiens sole supplier of automated image analysis for ProMark™ prostate cancer prognostic test

Definiens, the global leader in image analysis for digital pathology and diagnostics, announced today that it has signed a multi-year contract with Metamark Genetics, a privately held biotechnology company, to be the sole supplier of automated image analysis for the newly launched ProMark™ prostate cancer prognostic test.
ProMark™ is a multiplex immunofluorescence test that has successfully integrated Definiens’ core image analysis software technology platform to automatically classify prostate tumour regions of interest and quantify a novel biomarker expression panel from prostate biopsies. The ultimate result is a robust ProMark™ prostate score which allows for improved treatment decisions over current subjective pathology reads.
“Definiens was an integral part of the development, validation, and commercialisation of Metamark Genetics’ ProMark™ prognostic test. By utilising Definiens’ automated image analysis platform in the test, the importance and value of tissue datafication for accurate cancer prognosis and better treatment recommendations has been highlighted. ProMark™ and Definiens are now enabling clinicians to make the best decisions for their patients based on solid data,” said Thomas Heydler, CEO of Definiens.
The six year contract with Metamark Genetics includes multi-year term license fees and royalties. 

New MatrixRIB(™) MIPO instrumentation for less invasive surgical fixation

5th December 2013

DePuy Synthes CMF, a leader in skeletal and soft tissue repair and reconstruction, announce the launch of new instrumentation that enable less invasive surgical fixation and stabilisation of rib fractures with the company’s MatrixRIB™ System of precontoured, low-profile titanium plates, locking screws and intramedullary splints.
MatrixRIB(TM) Minimally Invasive Plate Osteosynthesis (MIPO) instrumentation was designed to provide surgeons with less invasive access, through small incisions, to rib fractures including difficult to reach sub-scapula rib fractures. The new instruments include a Trocar, Threaded Reduction Tool (TRT) with self-drilling tip, and 90̊ screwdriver with drilling capability. 
“Surgical fixation and stabilisation of painful rib fractures is a growing procedure and the introduction of new MIPO instrumentation should help make it an even more attractive option for both surgeons and patients,” said Karl Zerderfeldt, Group Marketing Manager, DePuy Synthes CMF.
  
Rib fractures are associated with respiratory complications, prolonged hospitalisation, prolonged pain, long-term disability and mortality.(1)  
The potential benefits of surgical stabilisation (osteosynthesis) of severe rib fractures over non-surgical treatments include reduced duration of mechanical ventilation support, shortened ICU stays and hospitalisation, better secretion management through efficient cough, and minimised chest wall deformities resulting from trauma.(2,3) 
More than 5,000 patients worldwide have received MatrixRIB implants since the System was launched in 2009. The MatrixRIB System is indicated for the fixation and stabilisation of rib fractures, fusions and osteotomies of normal and osteoporotic bone.*
MatrixRIB(™) is the only rib fixation system that is approved by the AO Foundation, an independent medically guided nonprofit organisation led by an international group of surgeons specialised in the treatment of trauma and disorders of the musculoskeletal system. For more information, visit www.aofoundation.org.
*Please refer to the MatrixRIB technique guide and package insert for full indications, contraindications, instructions for use, warnings and/or precautions
 
References
  1. Nirula R, Mayberry JC.:”Rib fracture fixation: controversies and technical challenges.” The American Surgeon. 2010 Aug;76(8):793-802.
  2. Ahmed Z, Mohyuddin Z: “Management of flail chest injury: internal fixation versus endotracheal intubation and ventilation.”, J Thorac Cardiovasc Surg. 1995 Dec;110(6):1676-80 
  3. Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S: “Surgical stabilization of internal pneumatic stabilization. A prospective randomized study of management of severe flail chest patients.”, J Trauma. 2002;52(4):727-32; discussion 32

Siemens presents new mammography system

3rd December 2013

Siemens has launched the MAMMOMAT Fusion, a new mammography system for screening and diagnostics at the annual conference of the Radiological Society of North America (RSNA).
The latest addition to the family of mammography systems from Siemens Healthcare combines robust technology with selected product features from the premium segment, addressing the specific needs of the midrange price segment, such as small to medium-sized hospitals.
Siemens Healthcare is one of the first manufacturers to integrate a new generation cesium-iodide detector in a mammography system, enabling the MAMMOMAT Fusion to deliver reliable and high-quality images. An innovative layered configuration of the photo diodes within the detector enables more efficient dose utilisation. This results in a higher resolution with a lower dose when compared with other caesium-iodide detectors.
The MAMMOMAT Fusion features OpDose, ensuring dose can be individually set for individual patients, without compromising excellent image quality. The appropriate parameters can be selected in accordance with the patient’s breast size and density. This, along with the large image matrix of 23 x 30 centimetres, means the MAMMOMAT Fusion is an excellent choice for screening various breast sizes.
The screening process has also been simplified for clinical staff thanks to the compact syngoTM based Acquisition Workstation (AWS), meaning patient data can be loaded directly from the Radiology Information System (RIS) without the need for a second workstation. Clinical personnel also benefit from an intuitive and automated workflow meaning the system can be ready to scan in just one click. Manual positioning is effortless, allowing more time and attention to be focused on the patient.
“Siemens Healthcare is thrilled to launch the MAMMOMAT Fusion at RSNA 2013, which features a new generation caesium-iodide detector helping to promptly deliver high-quality images,” states Lynn Blackburn, Mammography, Surgery and Urology Business Manager at Siemens Healthcare. “The system opens the doors to efficiency for the mid-range market, thanks to integrated technologies that were previously only available in the premium segment.”

Esaote’s first combined cardiac and vascular ultrasound diagnostic package

This year’s EuroEcho-Imaging conference in Istanbul, Turkey (11–14 December) will see global medical imaging manufacturer, Esaote, showcase Prevention Suite: a unique package of ultrasound imaging modalities for both cardiac and vascular investigations.
Prevention Suite provides clinicians with a wide range of tools for assessing a patient’s risk of cardiovascular disease quickly and reliably, often before symptoms occur. It is regarded as providing a ‘step change’ in terms of early detection and prevention of cardiovascular disease using ultrasound. 
The four advanced technologies that make up Prevention Suite are CFI, XStrainTM*, RFQIMT and RFQAS* which measure coronary flow quantification, cardiac deformation indexes, carotid intima-media thickness and arterial stiffness, respectively. The vascular measurements are performed using RF signal analysis which provides high spatial resolution for greater accuracy.
Professor Fausto Rigo, Head of Cardiac Diagnostic Imaging Department at Dell’Angelo Hospital, Mestre-Venice (Italy), has used Esaote’s Prevention Suite extensively in both inpatient and outpatient examinations. “For clinicians ranging from GPs to Cardiologists, Prevention Suite is a unique and technically superb ‘one-stop-shop’ for cardiovascular assessment.
It allows us to quickly and reliably make an appraisal of the patient, providing information about the actual biological risk of atherosclerosis. Prevention Suite’s resolution for vessel analysis is particularly impressive. There is no equivalent that allows us this multiplicity of information in the pre-clinical phase. Patients are fascinated by the examination too, and Prevention Suites’ real-life images are highly persuasive in convincing them to modify their lifestyle.”
Reducing CVD risk, cutting costs 
Early detection approach using imaging of key cardiovascular regions can be viewed as an important way of addressing an extremely costly issue: In 2011, the American Heart Association estimated that by 2030 the cost of treating cardiovascular diseases will rise from $273 to $818 billion.
Professor Cristina Giannattasio, Head Cardiology IV, Cardiologic Department at Niguarda Hospital, Milan, notes, “Atherosclerosis is one of the pathologies which can remain asymptomatic for a long time. The availability of dedicated cardiac and vascular measurements in the same device offers a more user-friendly and comprehensive assessment with the benefit of being able to detect early risk of CV disease.”  She adds, “In the future, preventative approaches will be the best way of reducing morbidity and mortality.”
Ongoing clinical studies involving hundreds of patients at clinical centres throughout Europe have started to show the benefits of a preventative screening approach. Professor Rigo explains, “The integration of cardiac and vascular assessments will help physicians identify the actual biological risk of atherosclerosis. Once clinical risk is identified, clinicians can work with patients on early intervention strategies and lifestyle modification before the risk of CVD escalates. As well as having clear patient benefits, pre-clinical assessments may help prevent hospitalisations and acute therapies, yielding significant long-term cost savings.”

Legionnaires’ disease Approved Code of Practice

26th November 2013

The Health and Safety Executive (HSE) has revised the Legionnaires’ disease Approved Code of Practice (ACOP) (L8), removing the technical guidance which will be published separately online.
Highlighting the benefits of the change, Lorraine Medcalf, HSE’s Legionella policy lead, said: “The revised ACOP provides greater clarity for dutyholders on what constitutes legal requirements and what is guidance. Where possible we have simplified terminology.
 
“The review also enabled us to update technical guidance to incorporate technological advancements and separate it from general guidance on the regulations, making it available on our website”.
 
The ACOP, which is aimed at dutyholders including employers; those in control of premises; and people with health and safety responsibilities for others, was one of several identified for review and revision; consolidation; or withdrawal, in line with a recommendation by Professor Ragnar Löfstedt in his report Reclaiming health and safety for all.
 
The revised publication was subject to consultation and received HSE Board and ministerial approval. It includes information on identifying and assessing sources of risk; preparing a scheme to prevent or control risk; implementing, managing and monitoring precautions; keeping records of precautions; and appointing a competent person with sufficient authority and knowledge of an installation to help take measures needed to comply with the law.
 
For the revised ACOP, see:
 
For the current version of the technical guidance, see:
 
Legal responsibilities to protect workers’ health and safety are not altered by any changes to ACOPs.