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Varian Medical Systems (Palo Alto, California) is struggling to commission Europe’s first full-service proton therapy center in Munich, Germany, and cannot predict when the doors will be opened to patients.

The setback with the Rinecker Proton Therapy Center (RPTC) poses a significant challenge to the boast by Varian CEO Tim Guertin that the company was on its way to building a “several-hundred million dollar proton therapy business.”

Varian built momentum last year toward that promise by adding a proton therapy capability with the January 2007 acquisition of Accel Instruments (Bergisch Gladbach, Germany), a private supplier of proton therapy systems for cancer treatment.

Proton therapy is considered the most advanced form of radiation treatment, using a particle accelerator to generate a beam of protons that can be targeted in three dimensions and more precisely deliver a high dosage of radiation to a tumor while sparing, or reducing, the damage to surrounding healthy tissue and organs

In March 2007, Varian reported the commissioning of Accel’s super-conducting cyclotron at the Paul Scherrer Institute (PSI; Villigen, Switzerland), calling it the world’s first commercial cyclotron for routine medical use.

Varian’s takeover of Accel was roundly welcomed, from Munich to Albuquerque, New Mexico, where at the Particle Accelerator Conference in June 2007, scientists said the combination of Accel’s proton therapy technology and expertise with Varian’s expertise in image-guided radiation therapy, treatment planning, information systems, clinical workflow, manufacturing, service and distribution would give the world a fully integrated proton treatment system from a single company.

By December, Varian said the FDA had cleared its proton scanning algorithms that the company claims will give clinicians greater control over how proton beams are used to target tumors and other abnormalities. What did not happen for Varian in 2007 was meeting the deadline imposed by its commissioning contract with the RPTC to open the first gantry and treatment room for patients on June 22.

By October, the supervisory board of the freshly completed E150 million ($220 million) facility went public with its frustrations, explaining to patients who are awaiting treatment that while the hardware is ready, the delay is caused by “Varian’s obvious difficulties to debug the Accel therapy control software modules.”

Dr. Markus Rinecker of the supervisory board of ProHealth (Munich), which operates the Rinecker center, told BB&T, “We have a long list of patients waiting for treatment. Some of them have literally died waiting for treatment because proton therapy was their last chance.”

Rinecker, the son of company founder Dr. Hans Rinecker, said, “We have seen massive delays. We do not understand what is causing all the delays. What we see is the hardware is working. Yet there are apparently a lot of issues with the software, with quality assurance and with the CE certification.”

He added: “We hear from Varian about specific technical areas, but I cannot tell you what is really keeping them from opening this center. We are not getting the big picture. Are they not capable? Are they confused by the merger with Accel? They do not give us any clues. Technically we should be there.

“I can only give you one side of this story,” he told BB&T, adding, “I will be very eager to hear what you are able to learn from Varian.”

Lester Boeh, VP of emerging businesses at Varian, told BB&T through a spokesman that the technology installed in Munich is by far the most advanced in the industry and “the commissioning work is continuing.” He said, “We’ve made good progress on the hardware and are working on completing the software that controls the treatment delivery. We have technical beam operating on all of the treatment gantries.”

Boeh added: “There is much work to do, but we are confident we will be successful. We look forward to the day when the system is ready for patient treatment.”

The new RPTC houses what is easily one of the largest medical devices in the world, at its heart a super conducting cyclotron built along the Isar River south of Munich. The beams are piped into Europe’s first purpose-built center for proton radiation therapy to provide a complete hospital setting for the treatment of cancer tumors.

With four gantries to deliver beams in separate treatment rooms and a fifth treatment room featuring a fixed beam, the RPTC boasts a throughput capacity of 4,000 patients per year. That compares with what Rinecker estimated is 50 patients per year at the PSI in Switzerland.

Where European medical device makers wait for years to receive reimbursement approval for innovative therapies from state health insurance funds, the RPTC is in the enviable position of already having an approval for proton therapy.

“Proton therapy is recognized for the contract covering about 45% of Germans,” said Rinecker.

“We are most eager to begin treatment for the patients who really can benefit from proton therapy, which is children. Children suffer the greatest effects from radiation therapy simply because they live longer and are still growing. Treating a tumor in the spine for a child is a very big help because it means fewer deformations as the spine develops, for example.”

Rinecker added: “We could open the doors tomorrow.”

Report says med-tech was 2007 ‘jobs engine’ in Germany

Specialization in high-tech medical technologies paid off handsomely for Germany in 2007, with the sector reporting strong job growth and steady innovation, as defined by the number of new products to be introduced in 2008.

The annual report from Berlin-based BVMed (German Medical Technology Association) shows 55% of the 140 med-tech companies taking part in the survey created new jobs in 2007, compared with growth of 45% for 2006 and 36% in 2005. The medical technology sector employs some 165,000 people in Germany.

The sector is a “jobs engine” for Germany, according to Joachim Schmitt, director of the association.

The report shows an average of 9% of annual sales revenue is invested in R&D with a third of the responding firms saying they invest far more. Eighty percent of the companies said they would bring new products to market in the coming year.

The mood in the sector is mixed, with less than half of the companies predicting improved results for 2007 over 2006. On average companies expect a 7% rise in sales.

Holding back enthusiasm is the uncertainty about reimbursement for new procedures, increased pressure on prices coming from purchasing syndicates, and hospital lump-sum-per-case payment policies.

The view that medical technology is seen as a cost driver by many health insurers, hospitals and doctors is challenged in a second report conducted by the Technical University of Berlin and corporate consultants Droege & Co. on behalf of the German electrical engineering and electronics industry association.

Titled “The Savings Potential of Innovative Medical Technology in Healthcare,” the study examins the impact on work processes and cost structures for 10 medical technology products, including an implant for joint closure and a procedure for removing cancer cells.

Annual savings ranged from E5 million ($7.5 million) to E990 million ($1.47 billion) and the total for all 10 products was put at E1.5 billion ($2.25 billion) per year.

A rapidly growing area among German companies is home care and BVMed is pressing for the greater acceptance and official recognition for home care as a subcategory under German social health laws. The association says the care being delivered and the med-tech products used to deliver that care are inseparable, representing “a cohesive and unique part of healthcare.”

Examples of home care tightly linked to products include dialysis, advanced wound care, pain and infusion therapy, and respiratory services.

The association is promoting a public policy statement of “ambulatory where possible, in-patient where necessary” to push official recognition and reimbursement.

German spending on medical devices and technologies amount to almost E20 billion ($29 billion) annually, making it the third-largest market for medical technologies in the world, according to BVMed, and the largest in Europe, with twice the volume of France and three times that of England.

1st pan-Asian Colorectal Cancer Congress being planned

Radiology experts from China, Korea, Japan and the UK convened as a steering committee group in London recently to draw up plans for the first pan-Asia CTC Congress. Congresses and workshops specializing in CTC already take place annually in Europe and North America. The organizers of the Asian meeting said the rising prevalence of colorectal cancer in Asia necessitates a meeting in that region to ensure the exchange of scientific and professional information about colorectal cancer screening and to encourage increased adoption of CTC by Asian radiologists.

The organizers said the Asia-Pacific region contributes almost half of the world’s cancer deaths. Colorectal cancer is the world’s second most prevalent cancer and is the cause of roughly 75,000 deaths annually in Eastern Asia (China, Japan, Korea, Mongolia) and the figure is rising.

Among individuals diagnosed with colorectal cancer, survival is highly dependent on how advanced the disease is at diagnosis. Five-year survival is 90% if the disease is diagnosed while confined by the bowel wall but only 65% once it has spread to the lymph nodes and 9% if it has spread throughout the body.

Most colorectal cancers arise from precursor lesions in the large intestine called “adenomatous polyps.” Screening is important because it means that adenomatous polyps can be removed before they become cancerous. Screening also detects asymptomatic cancer, which has a better prognosis than symptomatic disease.

There are a number of CTC screening tools available, each with advantages and disadvantages.

Colonoscopy is considered the gold standard for screening for colon cancer; however, data presented at last year’s American College of Radiology Imaging Network meeting showed that CTC is at least as sensitive as conventional colonoscopy in detecting adenomas of 1 cm diameter or larger. CTC is a less invasive option and unlike conventional colonoscopy, there is no need for the patient to undergo sedation and the risk of symptomatic colon perforation is much less.

In addition to offering “hands on” training workshops, the congress will encourage research collaboration among delegates and help to foster and cement relationships within the Asian radiology and gastroenterology community.

Medicsight (London), a developer of computer-aided detection and image analysis software for the medical imaging market, will provide an educational grant to facilitate logistical support for the inaugural meeting.

Rapid growth predicted for knee market in China

According to a report by the Millennium Research Group (Waltham, Massachusetts), sales of reconstructive knee implants will skyrocket in China, at an almost 25% compound annual growth rate from 2007 through 2012.

Strong economic growth, favorable demographics and an improving quality of life, particularly in the country’s urban areas, will drive this market throughout the next five years, according to the report, “Chinese Markets for Large-Joint Reconstructive Implants 2008.”

Millennium said the Chinese reconstructive knee implant market, currently pegged at nearly $100 million, will almost triple to reach just under $300 million by 2012.

“Because China’s strong economic growth has spurred the rise of a middle class, many now have the financial resources to improve their quality of life,” the company said. “Some of the country’s aging and osteoporotic citizens are doing so by spending on elective knee implant surgery. In order to accommodate this increasing demand, more surgeons are training to perform knee implant procedures.”

The Millennium group’s Global Markets for Large-Joint Reconstructive Implants report series covers India, the U.S., Japan, and Europe.

Three-phase accord for China is signed by Organogenesis

Organogenesis (Canton, Massachusetts) said last month that it has signed a memorandum of understanding with China’s National Tissue Engineering Center (NTEC; Shanghai), a stem cell and regenerative medicine consortium. Organogenesis formed the three-phase agreement with NTEC in early December while visiting China as a delegate of Massachusetts Gov. Deval Patrick’s trade mission to that country.

The NTEC is a central government-funded private company. Its founder, Professor Yiling Cao, is a well-known plastic surgeon trained at Harvard and the Massachusetts Institute of Technology (Boston) where, coincidentally, Organogenesis was originally founded. The NTEC comprises more than 70 scientists and growing teams of regulatory, production and commercial professionals and has recently completed the development of a new facility in a Shanghai Technology Park with manufacturing, R&D laboratories and business offices.

The first phase of the partnership will begin immediately and will include the commercialization and exporting of existing Organogenesis technology – including its signature product, Apligraf – in the Chinese market, and eventually throughout Asia.

The field of use in the memorandum of understanding covers wound healing and scars, but performance milestones may expand the scope of the agreement to include broader surgical uses.

Organogenesis said Phases II and III would follow, triggered by milestones achieved between the two companies. Phase II will include manufacturing existing Organogenesis cell therapies via a manufacturing site in Shanghai, necessary due to the short shelf life of living cell technology, including Apligraf.

Phase III will include the co-development of new technologies, which may be custom-designed for Chinese market needs.

French certification lab eyes orthopedics in U.S.

The Laboratoire National d’Essais (LNE; Trappes-Elancourt, France) reported that it has expanded its footprint for international certification of medical devices by sharpening its focus on orthopedic devices in the American market and winning recognition as a certification body (CB) for electro-medical devices in 49 countries. LNE set up an office for its division that focuses on medical device certification, called G-MED, in 2005 in Silver Springs, Maryland, close to the sprawling offices of FDA.

Last November LNE/G-MED was chosen by NuVasive (San Diego) for third-party certification of its new line of MaXcess minimally invasive specialized spinal implants that is currently undergoing clinical investigation.

Demonstrating conformity through a single CB testing procedure will assure NuVasive certification for MaXcess in the countries currently participate in the CB program. This international harmonization includes FDA approval through the 2002 Medical Device Modernization Act authorizing the Inspection by Accredited Persons (IAP) program, a CE mark for European markets, as well as approval for global markets that include China, India, Japan, Australia, Korea, Russia, Brazil, Canada and Argentina.

Many countries not formally participating in the CB program nonetheless use the certificaiton planning and audit process as the basis for their national certificaiton procedures.

PLC wins approval for RenalGuard, plans launch

PLC Systems (Franklin, Massachusetts) reported receiving the CE mark for its RenalGuard System, clearing the way for the company to begin initial launch of the product in the European Union.

RenalGuard is an automated, real-time, matched-fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media.

It is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects.

• HyperBranch Medical Technology (Durham, North Carolina) said it received the CE mark for its OcuSeal product, providing regulatory approval for sales in Europe and “potentially,” it said, in all other countries outside the U.S.

HyperBranch describes OcuSeal liquid ocular bandages as providing a protective barrier while stabilizing ocular wounds following surgical or non-surgical trauma and other ocular conditions.

OcuSeal is intended for direct application on corneal, conjunctiva, and sclera surfaces to provide a temporary protective barrier in post-surgical, post-traumatic, and non-traumatic ocular conditions.

The single-use device is terminally sterilized and allows for a one-handed brush application, according to the company.

The product is synthetic hydrogel which polymerizes in a moist field, flows optimally depending on the application, and is bio-degradable as the tissue re-establishes itself. The biocompatible composition is stored at room temperature and is delivered through the custom applicator to meet the specific needs of the procedure. The intended users of OcuSeal are ophthalmologists in a surgical or clinical environment.

• Tryton Medical (Newton, Massachusetts), a developer of stents designed for the treatment of bifurcation lesions received the CE mark approval for its Side Branch Stent. The Tryton Side-Branch Stent is a high-performance, cobalt chromium balloon-expandable coronary stent specifically developed for the complete treatment of the entire spectrum of coronary artery bifurcation disease.

“With the exception of Tryton’s stent, no dedicated solution exists today that fully addresses these lesions,” according to Tryton.

The results of the Tryton I (first-in-man) study were presented by Prof. Patrick Serruys, of Erasmus University/Thoraxcenter (Rotterdam, the Netherlands) and Ralf M ller, MD, of Helios Heart Centrum (Siegburg).

When the Tryton cobalt chromium bare metal stent was used with a standard drug eluting stent, no side branch restenosis was observed in the 30 patients treated. The initial core laboratory quantitative analysis reported a late loss of 0.27 0.42 mm in the side branch and 0.12 0.47 mm in the main vessel.

“This technology has the capacity to redefine the treatment of bifurcation lesions and resolve a frequent dilemma of the interventional cardiologist,” said Professor Patrick Serruys, MD, head of the department of interventional Cardiology/Thoraxcenter, Erasmus Medical Center.