BB&T European Editor and Staff Reports

PARIS – Prosthetics are advancing by leaps and bounds this summer.

In July, a giant step for people with disabilities was taken when double amputee Oscar Pistorius qualified for the first time with fellow South African sprinters in the 400-meter relay at the International Association of Athletics Federation (IAAF) World Championships in Daegu, Korea. The championships are scheduled to take place from Aug. 27 to Sept. 4 in Daegu.

The IAAF ban on athletes using “any technical device“ was overturned clearing the way for Pistorius to become the first amputee to run on prosthetic “blades“ against able-bodied athletes.

In July, Pistorius turned in a personal best time of 45.07 seconds for 400 meters, qualifying him for a spot on the South African national team.

He now has his sights set on the 2012 Olympics to be held in London, rather than the follow-on Para Olympics where he has become a legend and an icon for people with disabilities.

On the heels of this break-through, Otto Bock Healthcare (Egham, UK), reported the release of its next-generation C-Leg, a microprocessor-controlled leg prosthesis that intelligently adapts to an amputee's individual gait.

It has been 15 years since the original C-Leg was introduced and the long-awaited upgrade includes advanced software for controlling the 'swing phase' of the device, enhancements to performance with new motors and valves for the hydraulic system and an increase in battery life.

A significant new feature is defined modes of operation for walking, bicycling or standing still for long periods.

“Walking has been described as a controlled fall, and an above the knee amputee works hard at not falling all the time,“ said Phillip Yates, managing director of Otto Bock.

“When you are crossing the road in a crowd of people, stopping suddenly or moving forward too quickly can result in an unfortunate incident not only for yourself but involving other people as well,“ he said.

The goal of the microprocessor-assisted movement is to closely match natural human movement, mimicking the human skeletal system for balance and walking.

“The microprocessor knee unit actually knows where it is in the swing phase, whether you are coming off your heel of going onto your toe,“ said Yates.

“It measures where it is in space 50 times per second, it knows where you are in the cycle and how quickly you are walking, so that if any misadventure should occur, such as catching your heel or your toe, the unit will lock up to prevent you from stumbling and possibly falling,“ he said.

The C-Leg has been shown in consecutive clinical studies to reduce the incidence of falls by 64% when compared to mechanical knees.

Studies have also shown that by significantly enhancing the ability to walk, the C-Leg enables amputees to approach the behavioral pace and performance of able-bodied persons.

An overwhelming 90% of study participants reported improvement in function but also a meaningful transformation in the character of their everyday surroundings and a reduced sense of deficiency and displacement in relation to others.

The benefits of the C-Leg need to be compelling as the price tag for the prosthesis and fittings running to £30,000 ($50,000), more in the range of an automobile than a medical device.

It is a fair comparison, agrees Yates, adding, “These are two different levels of mobility, and to get back independence, amputees see there is a benefit.“

He said more than 40,000 C-Legs have been sold, and that six next-generation C-Legs had been sold prior to the product launch.

“It opens a new dimension for active amputees who are getting back to work or taking up activities of a normal life,“ he said.

Approved for reimbursement in most countries, the largest customer segment remains those who are able to pay for the device out-of-pocket.

For example, the C-Leg is approved for the UK's National Health Services Framework Agreement, though it is marked as restricted as it is cost-prohibitive for most patients.

The C-Leg, however, is widely prescribed by the U.S. military, Yates said, to help soldier rehabilitate themselves to a normal life and possibly for a return to active duty.

Otto Bock invests €37 million ($53.5 million) of its €528 million ($763 million) in annual sales revenue to research and development.

A sneak preview of upcoming products during the International Society for Prosthetics and Orthotics (ISPO) World Congress in Leipzig in 2010 included the Genium Prosthetic Knee System, a new platform that re-engineers the C-Leg technology.

“Genium takes a completely different approach resulting in additional functionality, such as the ability to walk up stairs, which the C-Leg can not do,“ said Yates.

At ISPO in Leipzig, Otto Bock also demonstrated a work-in-progress, the Michelangelo Hand.

Medtronic gets CE mark for 31 mm CoreValve

Medtronic (Minneapolis) said it has received the CE mark for its 31 mm Medtronic CoreValve system, the only transcatheter aortic valve available in the world that can treat– without surgery – patients with larger valve openings (up to 29 mm). It is the largest transcatheter valve available and, because it can be compressed into a small delivery system, is deployed through the same 18Fr (less than ¼-inch or approximately 6 mm in diameter) delivery system as smaller CoreValve sizes.

Medtronic's CoreValve portfolio now includes 26 mm, 29 mm and 31 mm valves – all based on the self-expanding platform that received CE mark in 2007. Individual sizing is critical to achieving optimal patient blood flow (hemodynamic function) and reducing adverse events, making the availability of an additional size an important offering to physicians and patients. The system is currently limited to investigational use in the U.S.

The CoreValve system is designed to provide a minimally invasive treatment option – without open-heart surgery – for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery. Worldwide, about 300,000 people have been diagnosed with this condition, and approximately one-third of these patients are deemed at too high a risk for open-heart surgery. Since 2007, the system has been implanted in more than 15,000 people in more than 40 countries.

Concord, GE sign MOU for new Chinese partnership

Concord Medical (Beijing), the operator of the largest network of radiotherapy and diagnostic imaging centers in China, said it has signed a memorandum of understating (MOU) with GE Healthcare (Chalfont, UK) to form a preferred strategic partnership in China.

Concord and GE have agreed to cooperate in academic and marketing programs, and plan to jointly organize new seminars and conferences in China to create more opportunities for scientific exchanges. Concord will partner with GE to enter and expand into rural and primary care markets in China, through financial leasing or other mutually beneficial business strategies.

The new partnership also includes a preferred supplier relationship in which Concord will be able to purchase GE's highly specialized healthcare products at the best possible prices. The GE products that will be supplied under the MOU include imaging equipment, monitoring devices and their after-sales services, solutions for healthcare IT solutions, clinical department solutions, Telemed, EMR, hospital integration platforms, performance solutions, consumables, and others. Additionally, GE will provide Concord with opportunities to provide financing related services for customers of GE in China.

CMED and Leica to co-develop FISH kits

China Medical Technologies (CMED; Beijing) and Leica Biosystems (Wetzlar, Germany), have established a sales and R&D collaboration to co-develop and market automated FISH kits to be used on the Leica BOND system. CMED will sell the kits in China and Leica will have an option to sell the kits in the rest of the world.

CMED and Leica will jointly develop automated FISH solutions for tissue sample tests on HER-2, EGFR and TOP2A on the Leica BOND system, an automated staining platform. HER-2, EGFR and TOP2A are genes in connection with the targeted cancer therapy drugs for breast cancer, lung cancer and stomach cancer patients. Automation of these FISH tests on the Leica BOND system will enable pathology laboratories and independent service laboratories to run these diagnostic tests more efficiently and with higher and more consistent quality.

The automation of FISH tests will also help users to reduce the work load pressure created by increasing test volumes, the companies said. Both parties agreed to add further FISH applications into the collaboration during the term, including for cytology and pre-natal applications.

“These collaborations with Leica mark a significant milestone for us,“ said Xiaodong Wu, CEO/chairman of CMED. “We believe that FISH applications will be more widely used in various clinical applications on automated basis in the future. By partnering with Leica, one of the leading global players in anatomic pathology, we can provide more efficient and higher quality FISH diagnostic solutions to the end users not only in China, but also in the global markets through Leica's extensive global network.“

“CMED is the market leader for FISH based diagnostics in China and has played a key role in the rapid development in the use of FISH in China, especially for tissue based companion diagnostic testing. This partnership will help Leica and CMED to offer customers in China a broad test menu of high quality FISH tests automated on the Leica BOND system,“ said Arnd Kaldowski, president of Leica Biosystems.

Msonix in Australia/New Zealand distribution

Misonix (Farmingdale, New York), a device company that designs therapeutic ultrasonic products for wound debridement, spinal surgery, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications, has entered into a new three-year exclusive distribution agreement with MD Solutions Australasia (Newport, Australia). MD Solutions will sell and distribute the BoneScalpel ultrasonic bone cutter throughout Australia and New Zealand. The agreement with MD Solutions includes annual minimum purchase requirements.

MD Solutions is highly experienced in marketing surgical devices and focuses on spine surgery, neurosurgery and other skull-based procedures.

The BoneScalpel is a tissue-specific osteotomy device capable of making precise cuts through bone and hard tissue while largely preserving delicate soft tissue structures. The BoneScalpel offers the convenience and speed of a power instrument while minimizing the potential risks associated with rotary sharps.

U-Systems granted license for somo v in Canada

U-Systems (Sunnyvale, California), a developer of automated breast ultrasound, has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell and market the somo•v Automated Breast Ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in Canada.

The somo•v ABUS ultrasound device is intended for use as an adjunct to mammography to provide physicians with an increase in the sensitivity of breast cancer detection in diagnostic symptomatic and screening asymptomatic women.

The company says that the system is the only ultrasound device approved for breast cancer screening by Health Canada, the agency responsible for assessing medical device safety, effectiveness and quality in Canada. It is also the only ultrasound device approved for breast cancer screening in the 27 European Union countries. In the U.S., the system is cleared by the FDA for adjunctive diagnostic use with mammography.

“With this approval from Health Canada, we are proud to make this critical screening tool available to improve the early detection of breast cancer in Canada,“ said Ron Ho, president/CEO of U-Systems. “The somo•v Automated Breast Ultrasound System is not intended as a replacement for mammography. However, there is a growing body of scientific evidence that supplementing mammography with ultrasound detects more cancers than mammography alone.“

Using technology to automate the breast ultrasound imaging process, the company says that the system is ideally suited for the high-volume, screening environment. The somo•viewer Advanced 3-D Workstation enables fast review and archive of patient exams, optimizing breast ultrasound screening workflow.

U-Systems is also the sponsor of the national SOMO•INSIGHT Clinical Study, which is designed to evaluate whether digital mammography in combination with somo•v ABUS is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with dense breast tissue. More than 15,000 women have participated in the study which is actively recruiting up to 20,000 women at multiple breast imaging centers nationwide. To date, the study has identified a significant number of mammographically negative breast cancers that were subsequently detected by ABUS.

Dehaier reports Chinese product approvals

Dehaier Medical Systems (Beijing), a company developing devices and homecare medical products in China, reported it was granted export certificates for five homecare medical products by the State Food and Drug Administration (SFDA) of the Peoples Republic of China (PRC).

The certificates, which were issued in June 2011 and are valid for two years, allow for Dehaier's Sleep Diagnostics product DHR-998, Dehaier Continuous Positive Airway Pressure (CPAP) products – DHR-AUTO-A8, C5, and C6, and the Dehaier Medical Air Compressor – to be exported without restriction, and serve as validation that the products meet PRC government requirements for sale and shipment overseas. Those certificates are necessary because it is prerequisite for certain countries.

The company also reported that it was awarded a new design patent for its sleep diagnostics products by the State Intellectual Property Office (SIPO) of the PRC. The new design patent, issued in July 2011 and valid for 10 years, increases the Dehaier intellectual property portfolio to six patents and five software copyrights, as well as proprietary technology.

“We are making progress toward expanding our business beyond China's borders, and believe the award of these export certificates is a critical first step to extending our geographic footprint,“ said Ping Chen, CEO of Dehaier. “Moreover, we are committed to investing in ongoing innovation, as we look to expand our addressable market through current product enhancements and new product introductions. We believe such a strategy will enable Dehaier to achieve its goal of meeting our customers' individual needs with a growing selection of homecare products.“

SmartGene expands scope of UZH collaboration

SmartGene (Zug, Switzerland), a provider of software services for the management and analysis of genetic data, and the Institute of Medical Microbiology (IMM), University of Zurich (UZH; Switzerland), reported an expanded collaboration. The University of Zurich will make use of the SmartGene platform and its associated reference databases to validate and provide ongoing back-up for mass spectrometry analysis, for the identification of infectious pathogens in diagnostic routine procedures. The parties already enjoy a long-standing relationship, under which SmartGene's advanced technology and integrated Web-based services are used by the IMM for the analysis and identification of bacterial, fungal and mycobacterial pathogens by sequence analysis.

The IMM is one of Europe's leading centers of expertise for molecular and conventional diagnostic microbiology and serves as a national and international reference laboratory. Experts at IMM conduct various research projects and also curate an ITS sequence reference database for identifying yeasts and molds, which is available to other institutions via SmartGene's service platform.

Clinical microbiology is undergoing a paradigm shift, whereby novel technologies such as mass spectrometry will partially replace conventional culture-based methods for identification of bacterial pathogens. The introduction of mass spectrometry technology promises a shorter turn-around time for results, along with reduced labor and consumable expense per test. However, earlier studies suggest that mass spectrometry may partly not be sufficiently discriminatory, for which case sequence-based identification will serve as back-up and gold standard. The IMM plans to work out an optimized workflow for the routine clinical laboratory, hence taking advantage of its long-standing expertise in sequence-based identification.

“Our institution has a long term expertise in implementing new technologies in the diagnostic laboratory, and we have always paid attention to carefully optimizing the work flow,“ said Erik Boettger, MD, professor of medicine and microbiology, and the director and chairman of the IMM at the University of Zurich. “We will now evaluate how mass spec technologies and sequence-based identifications can work together in our laboratory, for best accuracy and efficiency in supporting patient care. With mass spec platforms holding the promise of rapid identification of microorganisms, it is critical for the quality of our work, to be able to back-up and complement these results with our DNA sequencing routine and with our database cumulated from many clinical isolates over the years. Given the diversity of microorganisms, sequencing of microbial genes will play an important role in a modern microbiology laboratory. At our institution we appreciate SmartGene's technology which helps us not only to streamline sequence analysis, but also to leverage the expertise gained with the analyzed isolates.“