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.




Espicom Business Intelligence
The Medical Technology Blog

Welcome back to the Medical Technology Blog. Today’s article comes from the Cardiovascular Device Business Newsletter from Espicom Business Intelligence.

VentriPoint Diagnostics has met with the FDA to review its plans for the clinical trial and regulatory submission for the first application of the VMS heart analysis system for the congenital heart disease known as Tetralogy of Fallot. The FDA informed the company it had answered all its questions and addressed all of the earlier observations pertaining to the trial, paving the way for the start of the trial in the US.

The Tetralogy of Fallot study has begun in the US and is designed to show substantial equivalency between the gold-standard, MRI method and VentriPoint’s 2D-ultrasound, VMS technique. Based on advice from the FDA, the study has been designed to collect images at multiple sites and to analyse them in core labs. Nationwide Hospital in Columbus, OH is the lead centre for the study and the University of Nebraska has been named as a second site. A number of other clinical sites are expected to join the study. Nationwide Hospital has also been selected as the core lab for the analysis of MRI studies and the Hospital for Sick Children in Toronto, Canada has been selected to carry out all the analyses of the studies.

To date, 20 patients have been enrolled in the study and a total of 75 evaluable cases are required for study completion. VentriPoint anticipates enrolment will accelerate as the other centres become operational. The data collection should be completed this spring and a response from the FDA is anticipated this summer, depending on the rate or recruitment by existing and new centres.

VentriPoint estimates the market for product for Tetralogy of Fallot to be US$200 million and is already marketing the device in Europe and Canada, where it is approved for clinical use. The company has a target of placing 50 VMS devices in 2012 and anticipates that sales will increase rapidly during 2012 should FDA approval for Tetralogy of Fallow is achieved and approval for pulmonary hypertension is received in Europe and Canada.

The pulmonary arterial hypertension application is expected to over lap with the US congenital heart disease programme. A clinical evaluation of the pulmonary arterial hypertension application has already begun at the University of Chicago. This should be complete in a few weeks and, if successful, VentriPonit will use the data to file for CE mark and Canadian approval marketing applications. A number of medical centres have agreed to be part of this pivotal trial. Based on experience with the Tetralogy of Fallot trial, the company has already started the IRB and budget-approval processes with these major cardiovascular centres, as this is the most time-consuming part of the process. The sites will be selected shortly and will become operational as soon as possible.

Much of 2011 has been spent upgrading both hardware and software based on the feedback from the users and developing new applications such as pulmonary hypertension. The latest software, version 1.1, is completed and undergoing final testing. The major hardware feature expansion is the ability to interface with the newer digital ultrasound machines, which the company says is likely to  take over the market in the next five years. A key software enhancement is the ability to export VMS studies to the hospital PACS, enabling third party DICOM viewers to review the VMS results. Existing sites will be updated remotely with the new version as soon as it has been released for general use.

Looking ahead, VentriPoint is actively seeking partnerships with large manufacturers of ultrasound equipment for combination products and distribution. The company says there is considerable interest in developing a stand-alone system for pulmonary hypertension, as this would be a completely new application for ultrasound.

Article source: Lawrence Miller, editor Cardiovascular Device Business, and medical newsletters team leader at Espicom Business Intelligence



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