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




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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




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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

RESOLUTE US trial

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.

SYMPLICITY HTN-1 trial

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.

ADVANCE study

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.




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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

espicom-interactive-brochure-screenshot

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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Patient Sues Wright Medical Technology

The Medical Technology Blog

Patient sues Wright over defective ProFemur total hip system

Dale Purcell, a plaintiff from Phoenix, AZ has filed a lawsuit in the US District Court against Wright Medical Technology after needing emergency surgery following a sudden catastrophic fracture of the titanium modular neck of his Wright ProFemur total hip system in July 2011. Purcell had the device implanted in June 2005.

According to the complaint, the titanium modular neck used in the plaintiff fractured and broke very near the femoral stem, leaving a broken portion of the titanium neck wedged inside the stem. The fracture of the modular neck adapter caused failure of the system, requiring corrective surgery, and made it extremely difficult to extract the fragment. The complaint points out that “Studies have shown that modular neck adapters made from titanium alloy, such as the ProFemur modular neck adapter…are more likely to suffer fretting corrosion and fatigue fracture than those made from cobalt-chromium”.

A 2009 report by the Australian Orthopaedic Association claims to show that the Wright ProFemur Z femoral stem had a high failure rate, requiring approximately 11.2 per cent of all patients receiving the implant to need revision surgery. Wright is alleged to have changed the material in the ProFemur hip system modular necks in 2009 from titanium to cobalt chrome alloy, but took “no corrective action in the form of a recall or even an announcement of warning to the medical community or to the public at large concerning its decision to switch from titanium modular neck adapters to cobalt chrome adapters”.

Article source: Orthopaedic Business News kindly provided by Sophie Bracken, Espicom’s medical newsletters editor.



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Hospital for Sick Children Leading Child Health Research

The Medical Technology Blog

Sick Kids takes centre stage in robotics, imaging and simulation technology development

At first glance, a first time visitor to the Hospital for Sick Children, or “SickKids” as it’s more commonly known, could be forgiven for thinking that they were in a plush shopping centre rather than a major specialist paediatric hospital. Indeed, it has all the trappings of coffee bars, food outlets and such forth.  The downtown Toronto-based hospital is a sprawling campus of old and new buildings, colourful furniture and equipment, and boasts one of only three medical centres in the city equipped with a helipad.

Centre for Image Guided Innovation & Therapeutic Innovation

Somehow, the combination seems to works because the hospital has grown rapidly to become Canada’s largest centre for child health research. Supporting this strategy has been the Centre for Image Guided Innovation & Therapeutic Innovation (CIGITI), which was set up at SickKids in 2009 and, as part of a public/private partnership is developing three technologies with paediatric and foetal applications:, namely minimally-invasive endoscopic manipulators, a natural orifice anastomotic device and MR-guided high-intensity focused ultrasound.

In the case of the KidsArm technology development, the public contribution comes in the form of research and clinical expertise (SickKids) and government-based funding, whilst the private sector contribution encompasses contributing robotics (MDA Corporation), imaging (Philips Healthcare) and simulation (L-3 Communications MAPPS) technology.

The ambition for KidsArm can hardly be described as modest. The goal is for the technology to effectively to secure a position as a world leader in robotic surgery and imaging. Billed as the first robotic surgical arm for paediatric imaging, the device allows surgeons to navigate to a specific treatment area without impacting upon structures such as blood vessels. It could also be used to perform procedures such as the suturing of vessels and tissues at a rate of at least ten times faster than a surgeon.

The surgical platform is intended for use across all key surgical specialties, including cardiac, foetal, urosurgery/general surgery and neurosurgical areas. The device also has the benefit of producing virtual reality-based models that can be used in planning and teaching.

As with all high-profile technological breakthroughs, CIGITI has not got a clear field in terms of competitors, which include the likes of Intuitive Surgical, which has emerged in recent times as a leader in robotic technology through its DaVinci system. Still, confidence in the KidsArm’s attributes is strong and in a presentation to analysts, CIGITI isn’t afraid of holding back on a direct head on comparison with Intuitive Surgical.

First up, CIGITI says the KidsArm is markedly smaller and lighter than that from Intuitive, and that its device will be much cheaper and adaptable than its rival. As the KidsArm device is specifically targeted for paediatric use, it can also be used for any procedures that require minimal inversion. In contrast, Intuitive’s technology stands accused of being too large for paediatric use and limited to urological applications. Other technology standouts for KidsArm include built-in telesurgery and imaging guidance initially focused on MRI.

Unlike Intuitive, development of CIGITI’s technology is still at the relatively embryonic stage, although a clinical working model is expected to emerge within two years. Backed by C$10 million in funding awarded by the Canadian government in 2010, Phase I of the programme, which started in 2009, has been focused on the development of technological innovations such as in the areas of advanced complex surgical delivery, mulit-modality fusion and real-time image guidance and creation of surgical simulation models.

Whilst this process is still continuing throughout 2012, Phase II of the programme, which started in 2011 and will last two years, involves a critical analysis of the KidsArm technology. This includes a review of minimally-invasive surgery (MIS) vs robotic surgery, a look at fusion and real-time image-guidance and improving the accuracy of the surgical system and simulation modules. Analysis will also be carried out at high-frequency imaging for foetal intervention procedures. All this work, if it continues to impress, is likely to lead to commercial and clinical opportunities for the technology from 2014 onwards.

So why is a hospital taking such an active role in product development and when it’s primary role is providing healthcare provision? Aside from the revenue earning potential of creating IP assets that can be licensed or used for start-up companies, the collaboration stands to general high-end manufacturing jobs, healthcare and research opportunities and substantially improve education available from school students and rising all the way up to medical staff, both in Canada and the province of Ontario.

For SickKids, such efforts help to improve patient care and the quality of healthcare provided by the institution by introducing novel image-guided tools into the paediatric setting. So far, in just two years, SickKids/CIGITI has created a number of positions across all levels of academia, filed for three patents covering surgical tools (including one for KidsArm), secured C$25.8 million in research funding, signed a licensing agreement with Medical Modeling relating to patient-specific cranial facial models and templates and forged tentative links with venture capitalists.

Article source: Medical Industry Week – supplied by Lawrence Miller, editor.




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GE/UPMC bids to change the face of pathology

The Medical Technology Blog

Welcome back to our Canada Healthcare series from the Medical Technology Blog,

GE Healthcare

GE Healthcare has profiled efforts it is making to change the way in which pathology imaging is conducted across the globe. The opportunities, should its technology gain acceptance, looks set to deliver the final blow to an analogue-based procedure for looking at images that has largely remained unchanged over the past 120 years.

University of Pittsburgh Medical Center

Omnyx is a 50:50 digital pathology joint venture set up in partnership with the University of Pittsburgh Medical Center (UPMC) and GE. The business has chosen Canada as the location for its first Global Pathology Imaging Centre of Excellence (PICOE), located in the MaRS Excite campus in Toronto. The JV is investing C$7.75 million in the health technology programme, which is also backed by a C$2.25 million contribution from the Healthcare Technology Exchange (HTX). It is hoped that further collaborative R&D partnerships in the area will boost the over research figure by an additional C$7.2 million over the next three years.

In some ways, Canada represents ideal territory to test the benefits of digital pathology, mainly due to the sheer scale of the country and low population dispersion. The digitisation of pathology opens up the potential for remote medical centres to send contentious images fast and directly to regional centres and right into the lap of experienced pathologists.

The process would not only increase the number of images processed by pathologists, but it also comes as the healthcare environment suffers from a shortage of pathologists that has limited the capacity to get the most out of the resources available. GE believes that Canada has the level of awareness and political will to do something to fix the problem. The large regionalised healthcare system also lends itself to the Omnyx model, along with the clinical knowhow, and the number of trained clinicians able to support the rapid introduction of such an advanced technology.

Buoyed by an “ideal collaborative framework”, PICOE has government support, institutional backing community, including some of the biggest universities in Canada, as well as potential clinical partners such as the Ontario Institute for Cancer Research and hospitals. PICOE is not just about developing a new technology, but investigating how to take the system and deploy it across a nationwide, regionalised healthcare environment. The company says it benefits from the collaboration as it can apply this technology and methodology to other global healthcare markets.

Whilst PICOE is currently a research-use only tool that GE hopes will convince pathologists to ditch the old, cumbersome method and embrace a new form of working that will meet the challenges of modern pathology. As with all technologies that require a change in working techniques, it’s not a straightforward task that will be adopted overnight. However, the combination of innovative research and the influence of such a large business in GE Healthcare, could give PICOE a toe-hold in an industry that needs to be dragged kicking into the modern age.

The patent-pending Omnyx Integrated Digital Pathology (IDP) system includes whole slide scanners, pathologist and histology workstations and an integrated software platform that aims to deliver the scale and reliability for demanding pathology departments. The combination of a workflow server and digital archive combine to offer benefits such as: real-time image access from anywhere; the ability to automatically retrieve case information for individuals; image storage and retrieval; and, most notably, low entry cost and scalability.

The University Health Network is the first site to participate in the PICOE programme and will conduct both beta and clinical testing for primary diagnostics. It will also help to formulate guidelines and best practices for model pathology.

As of November 2011, UHN had scanned and reviewed over 2,000 slides as part of its testing activities.  This testing process started with five pathologists but within seven weeks had been expanded to 22 pathologists from nine specialty areas. A total of six Omnyx VL4 scanners, forming part of the DIP package, have so been shipped to beta customers worldwide.

At its core, the PICOE approach represents a “holistic” approach to pathology imaging, including scanners, servers, healthcare information systems and workstations, to provide a means of getting information out to the virtual community. GE will act as the exclusive distributor for Omnyx, and provides the implementation, training and support for the Omnyx Integrated Digital Pathology system.

Article provided by Lawrence Miller, editor of Medical Industry Week.

Next in the series….

…..Sick Kids takes centre stage in robotics, imaging and simulation technology development




Espicom Business Intelligence
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