FDA unveils plans for device ID system

The Medical Technology Blog

FDA unveils plans for device ID system for medical devices


Welcome back to the Medical Technology Blog, we have a great post today provided by our medical newsletters team-leader, Lawrence Miller. Lawrence is the editor for Medical Industry Week, please read on…

FDA proposal

In response to requirements in legislation that passed US Congress, the FDA has proposed that most medical devices distributed in the US carry a unique device identifier (UDI) in a move aimed at improving the quality of information in medical device adverse events reports.

The plans, which are now the subject of a 120 day comment period, aim to help the FDA identify product problems more quickly, better target recalls and improve patient safety. So far, the agency has conducted four pilot studies in the development of this proposed rule. With certain exceptions, under the proposed rule, a UDI would include a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and a production identifier, which includes the current production information for a device.

Risk-based, phased-in

The FDA is proposing a “risk-based, phased-in” approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The agency is proposing to exempt OTC devices sold at the retail level as these devices generally have UPC codes in place.

A UDI acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database called Global Unique Device Identification Database (GUDID), which will not contain any identifiable patient information.

The plans target the more accurate reporting, reviewing and analysing of adverse event reports so that problem devices can be identified and corrected more quickly. Other benefits include a reduction in medical errors and better management of medical device recalls.

Article Source: Medical Industry Week (MIW)

Espicom Business Intelligence
The Medical Technology Blog

German researchers look at materials to keep stents secure

Welcome back to the Medical Technology Blog, we have a great post today provided by our medical newsletters team-leader, Lawrence Miller, Lawrence is the editor for Cardiovascular Device Business, please read on…

Researchers from the Fraunhofer Institute in Germany are working on the development of a special surface coating that keeps the stent in place.

When coronary blood vessels are constricted, cardiologists try to prevent a heart attack by widening them with stent implants that stabilise the veins and arteries, improve the flow of blood and prevent vascular obliteration. These stents can be used to treat pathological constriction of the windpipe. This kind of respiratory stenosis, which may be caused by tumours, chronic infections or congenital deformities, can be life-threatening. In such cases, the metal or plastic stents are designed to enlarge the trachea and prevent it from closing up altogether. However, the stent implant can slip out of position, closing off the windpipe altogether. Bacteria can also colonise the stents and trigger pneumonia. The reason for this is that the stents have no barrier-forming cells of the kind usually present in the respiratory system, whose task is to fend off bacteria and inhaled substances such as particulate.

Dr Martina Hampel, a scientist at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in Stuttgart, working with Professor Thorsten Walles, head of the department of thoracic surgery at the University Hospital of Würzburg and a visiting scientist at the IGB, participated  in the “REGiNA” project, the goal of which was to develop surface coatings that enable the stents to be incorporated in the surrounding tissue, thereby reducing the risk that they will move. REGiNA, a German acronym for Regenerative Medicine in the Neckar-Alb and Stuttgart Region, is funded by the German Federal Ministry of Education and Research (BMBF).

The scientists used stents lined with a polyurethane (PU) film, which were produced by Aachen-based Leufen Medical. In the subsequent tests, a wide variety of different coatings were applied to the PU film. In addition to synthetic polymers composed of organic acids, the researchers also tried out biological proteins such as fibronectin and type-I collagen. The coating was modified again using plasma technology, with vacuum-ionised gas being used to treat the surface. The experts used an untreated PU film for control purposes.

In order to find out which of the surface coatings was the most suitable, the researchers brought both lab-cultivated cell lines and human primary tracheal epithelial cells into contact with the films in cell culture vessels. The primary goal was for the primary respiratory cells from human tissue to attach themselves to the film. The researchers achieved their best results with the protein-coated film, on which the primary tracheal epithelial cells grew particularly well and multiplied. The team found that whilst respiratory cells proved to be more vital on bioactive films rather than on ones treated with plasma, polymer-coated film turned out to be “completely useless.”

The laboratory tests have since been completed, and animal tests are currently being prepared. If the lab results are confirmed in these tests, the next step will be to conduct clinical trials of the modified stents at the Schillerhöhe specialist lung clinic, a part of the Robert Bosch Hospital. The hope is that, within a few years, well-tolerated, cell-compatible surface coatings will be available for use in other biomedical prostheses, such as pacemaker leads, tooth implants and replacement joints.

Article Source: Cardiovascular Device Business


Espicom Business Intelligence

Latest report on Cardiovascular Device Companies

The Medical Technology Blog

New report published – Cardiovascular Device Companies: Surveying the Global Competitive Landscape

This week sees the release of a new report published by Espicom Business Intelligence entitled Cardiovascular Device Companies – Surveying the global competitive landscape.

Whilst it doesn’t take a genius to conclude that the cardiovascular device market is a fast changing industry, it’s often very difficult to view these changes close up. It’s been seven years since we produced our first report focused on the Cardiovascular sector, and those changes keep on coming as we head towards 2013.

For a period of time, much of the focus was all about drug-eluting stents, and for a while at least the technology looked like fulfilling its potential. In truth, the technology has faced a perfect storm of bad news that has dogged its progress. First up, there was the pricing and cost-effective issue, then came subsequently panned EU data that suggested restenosis rates were just too high and last of all, this seemingly relentless worldwide recession came along and neatly priced potential customers out of the technology.

Last year came the unexpected news that continued declines in DES sales had persuaded Cordis to quit the industry. But it’s not all doom and gloom because the removal of a major competitor might actually reduce overcapacity in the sector. Technological improvements have come in the form of biodegradeable DESs and lessons have been learned in terms of product development and research.

The issue of reabsorbable DESs also features in the report overview section – a 14-page look at the regulatory climate in the US and in Europe. As Abbott stands poised to get marketing approval for its Absorb bioabsorbable vascular scaffold more than 18 months after European authorities gave its approval, we examine whether the FDA needs to more to bridge this gap or whether the EU system is just too quick for its own good.

It’s not just DESs that are the focus of attention. Edwards Lifesciences is also enjoying the fruits of long-term research and working its way through the somewhat unpredictable FDA pathway to get commercial release of its Sapien transcatheter heart valve. And boy, is the cash rolling in for the company in the US, where it dominates the market! Last year, transcatheter heart valve sales for Edwards jumped by over 60 per cent and now total US$334 million. That technology seems to have taken an age to get to the US market and some say the delay has effectively cost thousands of lives that could have been saved. Strong criticism indeed!

A detailed review of over 60 companies

This year the report has 60 companies that span the full breadth of the cardiovascular device field, ranging from cardiac rhythm management to interventional cardiology. Interestingly, after a long period of research and product fine tuning, the market for cardiac assist devices, such as ventricular assist devices, implantable heart replacement devices and other similar devices look to be approaching the first stage in the commercial endgame. The tell-tale sign is further consolidation within the industry and the focus on building a body of data to support the longevity of respective technologies.

One cannot also forget the rising profile of the renal denervation system, which represents a non-drug treatment option for hypertension. A reduction in systolic blood pressure, a function that underpins the technology, has cut incidents of stroke, heart disease and mortality. Most of the big players – including St Jude Medical and Medtronic – are working on significant trials of the devices, but it is also being driven by much smaller companies that want a slice of the action.

So there’s a lot to read – and a lot to take in and consider – about this year in our newly updated, and ever changing Cardiovascular Device Companies – Surveying the global competitive landscape report.

For more information regarding this report visit www.espicom.com/cdev


Espicom Business Intelligence

i-Optics starts major sales push

The Medical Technology Blog

i-Optics starts major sales push for its corneal topographer system

Welcome back to the Medical Technology Blog, we have a great post today provided by our medical newsletters team-leader, Lawrence Miller, Lawrence is the editor for Medical Industry Week, please read on…

Investors certainly seem happy enough with the progress of the Netherlands-based ophthalmic diagnosis company, I-Optics, which this week has unveiled a corneal topographer system, called Cassini, that is designed to detect higher order aberrations with far better precision and accuracy than with ring topographers. The release took place at the the annual meeting of the British Contact Lens Association and follows the completion of a series D financing round that resulted in the company’s coffers increasing by EUR .7 million.

Specifically aimed at expanding the market for multifocal, toric, aspheric and ortho-k contact lenses, the system aims to meet the challenges of opticians and optometrists in ensuring accuracy in fitting such devices in patients with premium contact lenses. The unveiling also follows on from another tipped for 2012 growth development, namely the EasyScan non-mydriatic retinal imaging system, which was released in late 2011.

Cassini is based upon colour LED topography (CLT), which has been developed with the Amsterdam VU Medical Centre and replaces the rings used in Placido topographers with 672 colour-coded LEDs set in a pattern, thereby offering superior precision and accuracy, also for dry eyes and irregular corneas. The technology can measure high and low order aberrations precisely and in any direction, in contrast to Placido topographers that are limited to accurate measurements in a radial direction. Further refinements of the technology could potentially include early keratoconus detection and progression monitoring, cataract and refractive surgery and LASIK surgery.

Keratoconus affects approximately three million patients worldwide, and early diagnosis is key to ensuring the best possible treatment. The CLT could potentially detect the condition and other corneal irregularities due to to its ability to measure small aberrations with submicron accuracy and precision. The indication is currently being tested in a patient study being carried out at an undisclosed eye healthcare centre.

Longer term, it could also be possible to measure the power and shape of intraocular lenses (IOL) more precisely by combining Cassini’s CLT technology with further technology that measures the axial length, anterior chamber size and other parameters for IOL fitting. I-Flow says the current devices generate a post-op error of 0.5D, whilst using Cassini could reduce this to 0.2D and result in a smaller number of patients requiring glasses after the procedure.

Article Source: Medical Industry Week

Espicom Business Intelligence

DSM agrees to pay US$360 million

The Medical Technology Blog

DSM agrees to pay US$360 million for Kensey Nash

Welcome back to the Medical Technology Blog, we have a great post today provided by our medical newsletters team-leader, Lawrence Miller, Lawrence is all the editor Medical Industry Week, please read on…

Kensey Nash’s Board of Directors has accepted a US$360 million (EUR 275 million), US$38.50 per share offer, from Royal DSM, a Netherlands-based company active in health, nutrition and materials. The offer is subject to customary conditions, including antitrust clearance, and is expected to be completed by the end of the second quarter of 2012.

Kensey Nash operates across five major segment areas, namely spine (15 per cent of first quarter 2012 revenue), sports medicine (30 per cent), CMF and trauma (16 per cent), cardiovascular (17 per cent) and general surgery (9 per cent). The company produces biomaterials for tissue repair and regeneration, as well as devices and equipment for the delivery of biomaterials and cardiovascular procedures. The strategy involves developing core materials and then working with established medical device companies in selected markets. Key products include the AngioSeal reabsorbable closure device, polylactic acid screws and anchors, bone cement and collagen minerals and collagen patches for general surgery.

Kensey’s collagen/ECM platform is supported by partnerships with St Jude Medical (cardiovascular), Arthrex (orthopaedics/sports medicine), Stryker (spine) and Synthes (CMF and trauma/general surgery). The reabsorbable polymers partnerships include orthopaedic/sports medicine (Arthrex, Orteq and Stryker), spine (Medtronic) and CMF and trauma (Athrex). Kensey’s Bone composites are supported by alliances in spine (Stryker, Synthes, Medtronic and Zimmer) and CMF and trauma (Synthes).

In 2012, Kensey expects to record revenues of US88.5 million, and EBITDA of US$30 million. This is set to rise in 2013 to US$100 million and EBITDA of US$36 million. The growth is expected to come from existing products, entry into new markets and the resulting impact of Kensey’s recent settlement with St Jude Medical over the AngioSeal product line. For DSM, the deal represents an opportunity to expand into two new growth platforms of life sciences and material sciences with a portfolio of products spanning the Bio-Passive (medical coatings and polymers), Bio-Active (reabsorbable polymers and drug- delivery) and Bio-Interactive (therapeutic materials and regenerative medicine).

The much changed DSM has spent the last five years developing a coatings and material drug-delivery business focused on cardiovascular and ophthalmic applications, and has subsequently strengthened these areas and also moved into developing spinal applications. The company, which relocated its HQ to Berkeley, CA, in 2010, is pinning its growth hopes on the cardiovascular, orthopaedic and ophthalmic markets for expansion. The process will involve expanding and developing its range of biomaterials further, whilst at the same time growing an emerging drug-delivery business. DSM will also look at opportunities for regenerative medicine and tissue engineering.

Article Source: Medical Industry Week

Espicom Business Intelligence

Sony’s Plan to Grow Medical Equipment Business

The Medical Technology Blog

Sony eyes growth in medical fields as company swings the axe in its higher profile electronics businesses

Welcome back to the Medical Technology Blog, we have a great post today provided by our medical newsletters team-leader, Lawrence Miller, Lawrence is all the editor Medical Industry Week, please read on…

Sony’s newly-installed management team have unveiled plans to cut a further 10,000 jobs in a bid to revitalise and grow the struggling electronics business to generate new value.
The plans, which will see the Japanese company focus on core areas of digital imaging, games consoles and mobile devices, aim to increase sales to ¥8.5 trillion, and provide a return on equity of 10 per cent, by the year ended 31st March 2015 (FY 2014). Sony’s 2011 sales were ¥7.2 trillion and have already been lowered for 2012 to ¥6.4 trillion.

Sony to grow medical equipment field - ¥50 billion sales by 2014?

Somewhat surprisingly, the turmoil in its high-profile electronics business, particularly with regards to televisions, is set to open doors for the company’s comparatively less profile medical peripherals division. In keeping with many of Japan’s electronic giants, Sony has been taken gradual steps into the medical field, particularly within the areas of medical-use printers, monitors, cameras and recorders. By the end of FY 2014, Sony is targeting sales of ¥50 billion (approximately US$630 million).

In a clear sign of its intention to grow the business, Sony also plans to enter the market for medical equipment components, where it believes its strength in various core digital imaging technologies offer significant competitive advantages in applications such as endoscopes. The latter has inevitably led to talk that the company may ultimately be interested in a tie-up with the scandal-ridden Olympus group, which is struggling to deal with a massive accounting fraud. Olympus’s diagnostic endoscopes dominate the worldwide market in this area. However, with Sony’s eye on other parts of its empire, and Sony’s less than impressive financial performance itself, a tie-up with Olympus seems a bit of a hefty deal to take on.
Such a takeover, however, cannot be entirely ruled out as Sony has also restated its determination to “aggressively pursue” other merger and acquisition deals that can expand its medical business, with the aim of developing the business into a key pillar of Sony’s overall business portfolio. The company recently entered the life science industry, where the company can apply technologies such as semiconductor lasers, image sensors and microfabrication, by purchasing iCyt, a manufacturer of cellular analysis equipment, and Micronics, a company that makes medical and diagnostics equipment.

It remains to be seen if three years from now the name Sony is regarded with more recognition than at the present time. However, given the current commentary coming out of the Japanese company, it seems at least one group of employees in the struggling company will be significantly more relaxed as the cost cutting programme swings into action.

Article Source: Medical Industry Week

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Novartis withdraws application for Exelon/Prometax extended indications

The Medical Technology Blog

Drug Delivery Insight Update

The EMA has been notified by Novartis Europharm of the latter’s decision to withdraw its applications for an extension of the therapeutic indication for  Exelon and Prometax (rivastigmine), 4.6mg/24h and 9.5mg/24h transdermal patches.

In March 2011, Novartis submitted an application to extend the marketing approvals for the two transdermal patches to include a new indication for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. At the time of the withdrawal, the application was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Exelon was first approved in the EU in May 1998, and its duplicate, Prometax, was approved in December 1998. The transdermal patches are currently intended for the symptomatic treatment of mild-to-moderately severe Alzheimer’s disease.

The company stated that it decided to withdraw the application after the CHMP indicated that in order to conclude a favourable approval additional data was required, which could not be generated within the time-frame allowed in the centralised procedure. Both medicines continue to be approved in the currently approved indications.

Article source: Espicom’s business publication Drug Delivery Insight, edited by Sophie Bracken.


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Medtronic’s Busy Period for Research & Development

The Medical Technology Blog

Welcome back to the Medical Technology Blog. Apologies for the lack of posts lately, busy times at Espicom, thanks for your patience. Today we have a detailed post taken from Espicom’s business publication, Cardiovascular Device Business, please read on…

Medtronic caps busy period for R&D with trial data from DES, pacemakers, heart valves and renal denervation study programmes


According to two-year follow-up data from the RESOLUTE US trial, Medtronic’s Resolute drug-eluting stent (DES) maintains a powerful and persistent treatment option for a wide variety of patients with coronary artery disease, including those with diabetes mellitus.  The Resolute DES was approved by the FDA in February 2012, with a specific indication for the treatment of coronary artery disease in patients with diabetes mellitus.

The RESOLUTE US trial enrolled 1,402 patients across 128 US-based clinical trial sites. The two-year results among 1,359 patients include low rates of TLF (7.3 per cent), clinically-driven TLR (4.3 per cent), and def/prob ST (0.2 per cent). These results were achieved despite 34 per cent of the patients having diabetes mellitus, which typically drives higher event rates. Among the 474 patients with diabetes in RESOLUTE US, the Resolute DES showed low two-year rates of TLF (8.9 per cent) and clinically-driven TLR (5.7 per cent) and no def/prob ST (0.0 per cent).

Pooled analyses, provided by the worldwide RESOLUTE clinical programme, consisted of a large randomised controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. In total, the programme enrolled 5,130 patients who received a Resolute DES; about one third (n=1,535) of these patients had diabetes, a proportion that mirrors the US patient mix for percutaneous coronary intervention (PCI). For the pooled analyses related to safety and diabetes, two-year data on more than 5,000 patients from the RESOLUTE programme who received a Resolute DES were included. Individual trials, while designed for many composite endpoints, are often underpowered to show real differences for low-frequency, but clinically important adverse events such as ST.

The two-year update to RESOLUTE Pooled Safety showed very low rates of clinically-driven TLR (4.7 per cent) and def/prob ST (0.9 per cent), despite 46 per cent of the patients in the RESOLUTE programme being considered complex. Additionally, the two-year update to RESOLUTE Pooled Diabetes, which presents clinical outcomes in patients with and without diabetes who received a Resolute DES, shows consistently low event rates out to two years despite the higher-risk nature of the diabetes patient population.

In a separate development, two clinical trials relating to Medtronic’s Symplicity renal denervation system show that the treatment provides safe, significant and sustained blood pressure reduction for up to three years in patients with treatment-resistant hypertension. The system is not yet cleared for the US market, but has been available since April 2010 in certain parts of Europe, Asia, Africa, Australia and the Americas. The FDA granted Medtronic approval for the protocol for SYMPLICITY HTN-3, the company’s US trial of the Symplicity system, for treatment-resistant hypertension, in August 2011.


Results from the SYMPLICITY HTN-1 trial showed sustained safety and effectiveness of renal denervation with the Symplicity system for up to three years, and results from the SYMPLICITY HTN-2 trial showed safe, sustained and significant blood pressure reduction one year following the procedure. Renal denervation therapy is a minimally invasive, catheter-based procedure that modulates the output of nerves that lie within the renal artery wall and lead into and out of the kidneys. These nerves are part of the sympathetic nervous system, which affects the major organs that are responsible for regulating blood pressure: the brain, the heart, the kidneys and the blood vessels.

SYMPLICITY HTN-1 is a series of pilot studies involving 153 patients at 19 centres in Australia, Europe and the US. Subjects in the trial maintained an average blood pressure reduction of -33/-19 mm Hg at 36 months (n=24) from baseline (p<.001) following treatment with the Symplicity system. An increasing proportion of patients who completed follow-up had at least a 10 mm Hg reduction in systolic blood pressure. At six months 71 per cent of patients were classified as responders, which increased to 100 per cent among the patients who completed three year follow-up. There was no evidence of renal impairment, no patients were hospitalized due to hypotension, and no procedure-related serious adverse events were seen.

The SYMPLICITY HTN-2 trial is an international, multi-centre, prospective, randomised, controlled study of the safety and effectiveness of renal denervation in patients with treatment-resistant hypertension. In total, 106 patients were randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone (control group) at 24 participating centres. At baseline, the randomised treatment and control patients had similar high blood pressures: 178/97 mm Hg and 178/98 mm Hg, respectively, despite both receiving an average daily regimen of five antihypertensive medications.

The one-year follow-up analysis included data from 47 patients initially treated, who at 12 month follow-up sustained their significant drop in blood pressure (-28/-10 mm Hg [p<0.001] from baseline) with no significant difference from the previously disclosed six month follow-up (-32/-12 mm Hg [p=0.16]). In addition, 35 qualified patients in the control group who received renal denervation six month post randomisation also showed a similar drop in blood pressure to the treatment arm at 6 months post procedure (-24/-8 mm Hg [p= 0.15] from 6 month treatment arm). Safety results were sustained with no significant decline in kidney function and no late vascular complications.

The Symplicity system consists of a flexible catheter and generator. In an endovascular procedure, similar to an angioplasty, the physician inserts the small, flexible Symplicity catheter into the femoral artery in the upper thigh and threads it into the renal artery. Once the catheter tip is in place within the renal artery, the generator is activated to deliver a controlled, low-power radiofrequency energy routine according to an algorithm that aims to deactivate the surrounding renal nerves. This, in turn, reduces hyper-activation of the sympathetic nervous system, which is an established contributor to chronic hypertension. The procedure does not involve a permanent implant.

ISSUE-3 study

In the area of pacemakers, Medtronic has released data from a double-blind, randomised study, ISSUE-3, which found that patients who suffered from fainting due to neurocardiogenic syncope had fewer fainting occurrences when treated with a Medtronic pacemaker. The data showed a statistically and clinically significant 57 per cent relative reduction of fainting recurrence in patients at two years. In the study, patients at high risk for syncope recurrence (asystolic neurally-mediated syncop) were identified through the use of Medtronic’s Reveal range insertable cardiac monitors (ICM), thereby allowing physicians to determine which patients could benefit from a pacemaker implant.

While a previous observational study, ISSUE-2 (International Study on Syncope of Uncertain Etiology-2), showed that the use of an ICM effectively diagnosed asystolic syncope, thereby leading to effective treatment outcomes, the ISSUE-3 study was needed to confirm these results through a more rigorous, randomised controlled trial. The ISSUE-3 study was conducted at 51 centres in Western Europe and Canada in two phases: a screening phase, followed by a treatment phase. From September 2006 to November 2011, 511 patients met the inclusion criteria and received a Reveal device to assist with the diagnosis of each patient’s syncope.

Results of the ISSUE-3 trial showed that fainting re-occurred in 185 of the 511 study patients (36 per cent) and was documented by the ICM in 141 (76 per cent) of these patients. The Reveal ICM diagnosed 51 per cent) of patients with reoccurring fainting as an asystolic event, indicating them for a pacemaker and making them eligible for the treatment phase of the study. These patients received a dual-chamber Medtronic pacemaker and were randomised 1:1 (pacemaker on and pacemaker off). The treatment phase showed significant reduction in recurrence of fainting in patients who received Medtronic pacemaker therapy. For patients receiving pacemaker implants, the fainting recurrence rate was 25 per cent when the pacemaker was turned on and the fainting recurrence rate was 57 per cent when the pacemaker was turned off.

Medtronic pacemakers are currently indicated for use in patients who have experienced one or more of the following conditions: symptomatic paroxysmal or permanent second- or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders and bradycardia-tachycardia syndrome.

Meanwhile, the largest international, prospective, single-arm clinical trial evaluating Medtronic’s CoreValve system in patients with severe aortic stenosis who are at high-risk for surgical aortic valve replacement (SAVR) showed that, in a real-world setting, patients experienced high procedural success combined with positive clinical outcomes. The CoreValve system is currently limited to investigational use in the US, but has been CE marked since 2007 for treatment of patients deemed at high or extreme risk for SAVR.


The CoreValve ADVANCE study displayed survival rates of 95.5 per cent at 30 days and 87.2 per cent at six months, which are consistent with previously disclosed data from national registries in Europe. The procedural success rate was 97.8 per cent, and overall complication rates were low with stroke rates of 2.9 per cent and MACCE rates of 8.3 per cent at 30 days. Patients in the study experienced significant improvement in valve function (mean gradient decreased from 45.6 mmHg at baseline to 9.3 mmHg at 30 days).

According to Medtronic, the study is one of the largest multicentre transcatheter valve trials to date, with 1,015 patients (mean age of 81 years) consecutively treated at 44 transcatheter aortic valve implantation (TAVI) centres across 12 countries. Clinical endpoints in the trial were calculated according to Valve Academic Research Consortium (VARC) standardised definitions. All data were independently monitored, all adverse events related to the primary endpoints were adjudicated by an independent Clinical Events Committee (CEC) consisting of experienced cardiac surgeons and interventional cardiologists, and all cerebrovascular events (including stroke and other events) were adjudicated by an independent neurologist using neuroimaging and systematic NIH Stroke Scale assessments.

This article was taken from Cardiovascular Device Business, edited by Lawrence Miller, Espicom’s medical newsletters team leader.

Espicom Business Intelligence

Introducing Espicom Interactive

The Medical Technology Blog

Introducing Espicom Interactive – Espicom’s new online delivery platform

Welcome back to Pharmaceutical News. Today we have some exciting news, the launch of our new service Espicom Interactive.

Espicom Interactive is our new feature-rich online delivery interface which provides a range of powerful and useful time-saving functions. Available now, Espicom Interactive lets you maximise the value of your Espicom service, with features such as the ability to save your researched text instantly to MS Word. Tables, graphics and illustrations are instantly opened and saved in MS PowerPoint and MS Excel.

Field staff and agents worldwide will benefit from machine translation into 9 languages, which cover key emerging markets such as Brazil and China. Watch the instructional video below to assess the power and versatility of the Espicom Interactive platform.

Espicom Interactive Instructional Video


For many companies the cost of business information represents a significant investment. Its practical use in defining commercial strategy and in understanding market environments is critical to success. However, the value of such investments is only really beneficial if the service empowers staff to greater efficiency in its use. Business information should be a support to effective decision making and not a burdensome administration task.

To download the Espicom Interactive Brochure please click on the thumbnail below


To access Espicom Interactive and review a sample document which will let you try the service for yourself at no charge, please click on the link to Espicom Interactive

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UK healthcare sector investment

The Medical Technology Blog

Investment in nanoscience set to benefit UK healthcare sector

Grant funding totalling over £6.5 million has been awarded for seven business-led projects that will focus on developing therapeutic agents and diagnostics where nanoscale technologies are the focus of innovation. The funding will be provided by the UK Engineering and Physical Sciences Research Council (EPSRC) and the Technology Strategy Board, and the projects will be led by Critical Pharmaceuticals, Johnson Matthey, Mologic, Nanomerics, OJ-Bio, Renishaw Diagnostics and Sharp Laboratories of Europe.

The aim of the investment is to help ensure that the UK can become an early competitive adopter of these technologies and rapidly meet the urgent and difficult challenges posed within the worldwide healthcare sector, by translating early-stage ideas from academia and commercialising them through the building supply chains with businesses. This investment is part of a two-stage initiative under the Nanoscience through Engineering to Application Grand Challenge for Healthcare. The university partners on two of the funded projects had initially received three years of funding from EPSRC and these projects will follow onto scale-up the technologies developed in the first stage.

The proposed R&D projects will seek to develop closer links between the healthcare community and the emerging nanoscale technologies community, in order to rapidly develop and commercialise early-stage nanoscale technologies. Key challenge areas include the earlier and better detection and diagnosis of disease, leading to marked improvements in patient outcomes, and effective treatments that are tailored to patients’ needs, and which either modify the underlying disease or offer potential cures.

£1 million UK government funding

Separately, a group of projects are to receive over £1 million of UK government funding to enable them to develop new and improved “health-economics” tools or products that will assist and improve the design and evaluation of clinical trials for infectious agents. The funding, from the Technology Strategy Board, in partnership with the Department of Health, UK and with additional contributions from EPSRC to fund academic social science components, has been awarded for three development contracts. These will be undertaken by Diagnostics for the Real World (Europe), Integrated Medicines and the Health Protection Agency.

The funding award follows the organisations’ participation in the “Assessing the Impact of Near-Patient Testing” competition for development contracts managed by the Technology Strategy Board and developed in discussion with the National Institute for Health and Clinical Excellence (NICE) and the British In Vitro Diagnostics Association. The competition was run under the Technology Strategy Board’s infectious disease programme that aims to reduce the economic burden, death and illness of such diseases.

Two of the projects, to be undertaken by Diagnostics for the Real World and the Health Protection Agency, will focus on sexually transmitted infections, while the remaining Integrated Medicines project will focus on sepsis.

Article source: Kindly provided by Sophie Bracken, editor of Espicom’s business publication Diagnostics Focus

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