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…

NTUH joins selective club that have achieved successful robotic-assisted kidney transplant.

An organ transplant team at National Taiwan University Hospital (NTUH) has become the first to carry out a robotic-assisted kidney transplant procedure in Asia.

The procedure involved the use of Intuitive Surgical’s da Vinci robotic surgery system, an FDA cleared system that is approved in the US for use in urological, general laparoscopic, gynaecologic laparoscopic, selected transoral otolaryngology, general thoracoscopic and thoracoscopically-assisted cardiotomy surgical procedures. Whilst robotic surgery has been used in all kinds of operations on human, robotic surgery has not gained widespread use in organ transplantation, due to insufficient manoeuvring space caused by the implant organ, as well as the requirement for a precise vascular suture technique and risk of haemorrhage. So far, only a few cases from European and American countries have been reported in literature.

The traditional open transplant requires a 15 to 20 cm incision, but causes more pain and discomfort for patients, and can trigger wound hernia due to high tension. In order to reduce postsurgery discomfort for patients, the NTUH organ transplant team has been working developing a robotic surgery system for organ transplantation.

In late July, NTUH’s organ transplant team successfully completed the milestone procedure. The surgery requires a few small incisions and efficiently decreases the possibility of complications. The team believes that accomplishment of this robotic assisted kidney transplant is an important milestone for organ transplant development.

The da Vinci system is used to used to mirror the movement of the surgeon’s hands using two controller sticks. The system offers high definition 3D vision and magnified views. Additionally, in comparison to traditional surgical techniques it is regarded as minimally invasive, offering the patients the benefits of rapid recovery and a small incision, whilst lowering the potential for complications.

Article Source: Medical Industry Week (MIW)

Sunquest becomes latest company to meet Roper’s key acquisition criteria

Welcome back to the Medical Technology Blog, we have a great post today provided by Sophie Sanderson. Sophie is the editor for Diagnostics Focus , please read on…

Adding to its vastly expanding medical platform and honing in on its focus on diagnostics, Roper Industries has set its sights on the acquisition of Sunquest Information Systems, a provider of diagnostic and laboratory information systems to healthcare providers worldwide, in an all cash transaction valued at nearly US$1.5 billion.

Roper expects the acquisition of Tucson, AZ-based Sunquest to be immediately cash enhancing and to generate around US$140 million or more of EBITDA in 2013. Sunquest, which has offices in the UK and India, is owned by a group of investors resulting from a 2010 recapitalisation led by Huntsman Gay Global Capital, in partnership with Vista Equity Partners, which has owned the company since 2007. Sunquest is expected to be an ideal fit with Roper’s Medical and Software platforms – which represents just one of the latters four business segments.

Roper is perhaps more commonly known as a designer, manufacturer and distributor of radiofrequency products and services, industrial technology products, energy systems and controls, as well as medical and scientific imaging products and software. Roper’s Medical and Scientific Imaging segment primarily offers products and software in medical applications, high performance digital imaging products and software, and hand-held and vehicle mount computers.

Focusing on the company’s Medical and Scientific Imaging segment, net sales in this area for 2011 were US$611 million, representing 22 per cent of Roper’s total net sales, which reached an impressive US$2.8 billion. Acquisitions alone added US$26 million in sales for the year ended 2011.

With claims that its balance sheet is stronger than ever before, and enjoying the more recurring revenue from its disciplined acquisitions of the last several years, it is unlikely that Sunquest will be the last in a string of revenue-generating acquisitions for the company.

Source material: Diagnostics Focus

MiCardia gets busy with its mitral valve technology

Welcome back to the Medical Technology Blog. In the first instalment of her guest blog, Coral Campbell highlights interesting developments from Irvine, CA-based MiCardia. Please read on…

MiCardia has had its hands full this week with a successful fundraising venture that received the thumbs up from its investors and culminated with the spin-off of its transcatheter technology.

The spin-off company, called ValCare, has backing from an Israeli investor, will be hoping for big things from its transcatheter technology. The venture has US$8.0 million to further advance the technology and holds the intellectual property for the company’s transcatheter mitral valve repair system.

ValCare’s transcatheter mitral valve repair system uses interventional cardiology methods to implant a mitral annuloplasty device – a target market potential that has been touted to be worth upwards of US$3.5 billion. The next job for the company is to complete the development and test the device in pre-clinical studies in the near term.

Back at MiCardia, investors have given the company a vote of confidence by backing a near US$4.5 million funding programme. The cash will help support the business during the rest of 2012 and 2013. MiCardia plans to use the proceeds of this funding to expand the commercialisation of its enCorSQ mitral valve repair system in Europe and selected countries worldwide.

Article Source: Cardiovascular Device Business

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)

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

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

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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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

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

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.