BB&T European Editor and Staff Reports

PARIS – Europe's first commercial proton therapy center shifts into second gear this month with the opening of a second treatment gantry and the center's operator, ProHealth (Munich, Germany), expects to hit top speed with the opening of two further treatment rooms by July.

Commissioning the Rinecker Proton Therapy Center (RPTC) in Munich lifts a cloud that has hung over the emerging business unit of Varian Medical Systems (Palo Alto, California) since the company took over the troubled project in 2007 with the acquisition of Accel Instruments (Bergisch Gladbach, Germany).

ProHealth reports the delays, and ultimately the collapse of Accel, were caused by about 100,000 lines of code, or about 5% of the entire software volume that drives the complex mechanical and electromagnetic forces capable of delivering a proton beam with one millimeter accuracy from a super conducting cyclotron located 92 meters away (302 feet).

Unlike conventional X-ray radiotherapy that scatters a wider area, exposing healthy as well as cancerous tissue to radiation, proton therapy delivers heavier particles in a beam to destroy tumors in a highly controlled dose and exposure.

Patients are not in proximity to the source of radiation, and the greater precision of the prescribed doses, or fractions, with proton beam therapy results in fewer treatment sessions.

The Varian Proton Therapy System received a CE mark in February 2009, enabling the company to market this commercial system in more than 30 countries.

ProHealth plans to construct new centers in Leipzig and Cologne, but has not yet announced whether it will contract with Varian, according to a company spokesman.

A second German health group announced it would build a proton therapy center in Heidelberg and the MedAustron center in Vienna, Austria is planned for 2014.

Among European countries, only Germany has approved reimbursement for proton therapy.

Bringing online the e150 million ($209 million) RPTC is a “proud achievement,“ according to Moataz Karmalawy, head of the Varian's Particle Therapy Group that led the engineering, installing and commissioning.

“From our perspective, RPTC is the first system that is not a research facility and the certification is the first for a complete system,“ he said.

While Europe can claim proton therapy centers dedicated to research in England, France, Germany, Italy, Sweden, and Switzerland, RPTC is the first dedicated to full patient treatment from diagnosis to follow-on care featuring a complete hospital setting.

ProHealth expects to treat 4,000 patients a year at RPTC.

German court rules in Medtronic's favor

Medtronic (Minneapolis) reported that an appeals court in Germany has found that its CoreValve transcatheter aortic valve system does not infringe Edwards Lifesciences' (Irvine, California) Germany Andersen patent, which is set to expire in May 2011.

The appellate court's decision upholds a lower court's ruling and enables uninterrupted access to the heart valve in Germany, Medtronic noted. The company said that court proceedings involving the U.K. counterpart to the German Andersen patent are scheduled to resume May 14 in London with an appeal from the trial court. The U.S. District Court of Delaware is scheduled to begin a trial March 23 involving related U.S. patents.

As in Germany, the U.K. trial court found in January 2009 that CoreValve devices do not infringe the Edwards' U.K. Andersen patent, Medtronic said.

Medtronic contends that CoreValve devices do not use the technology disclosed and claimed in the Andersen patents. As a result, the company maintains that it does not need a license to those patents in order to sell CoreValve devices.

The CoreValve transcatheter aortic valve system is designed to enable replacement of a diseased aortic valve without open-heart surgery and without surgical removal of the diseased valve.

Edwards said the ruling has no effect on sales of the Edwards Sapien transcatheter heart valve technology.

In January the Federal Patent Court in Munich, Germany, upheld the validity of Edwards' patent for transcatheter valve technology and Edwards succeeded in having CoreValve's invalidity claims dismissed on all grounds, Edwards noted.

Siemens wins $70M Iraqi equipment contract

Siemens Healthcare (Malvern, Pennsylvania) will supply diagnostics imaging equipment to all Ministry of Health hospitals (around 100) across Iraq. The recently signed contract has a value of around $70 million and is the biggest single order contract to be awarded to Siemens Healthcare in the Middle East.

The products, which include magnetic resonance imaging and computed tomography equipment, mobile X-rays and mammography systems, help to increase diagnostic confidence, allowing for earlier detection of diseases. The equipment will be fully serviced over a period of five years.

“We are very proud to announce this agreement as it means we are playing an active role in the helping rebuild healthcare services in Iraq,“ said Maurice Faber, VP Siemens Healthcare Sector Middle East. “One major result of this contract will be improved healthcare for all Iraqi people, and advanced breast cancer screening facilities for women in Iraq.“

Staar gets Japanese approval for Visian ICL

Staar Surgical (Monrovia, California) reported regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its Visian Implantable Collamer Lens (ICL) in Japan.

Japan's MHLW approved marketing the Visian ICL for the treatment of myopia. The Japanese population is believed to suffer one of the highest rates of myopia in the world, with a much higher percentage of the population in the high myopic range than the worldwide norm.

Having achieved ICL approval, the company now intends to file a partial change application for approval of the Visian Toric ICL approval in Japan as soon as practicable following discussions with the Pharmaceuticals and Medical Device Agency. MHLW generally requires up to one year to fully process a partial change application, although that timeline can change based on the nature of the product under review.

Study pits Genous stent against Endeavor

OrbusNeich (Hong Kong) reported that the first patient has been enrolled in a randomized clinical trial of the Genous Bio-engineered R stent in China. A multicenter, randomized, controlled study, the trial will enroll 180 patients split evenly between the control and test arms at 11 sites countrywide, the researchers said.

The primary study objective is to demonstrate the safety and effectiveness of the Genous Bio-engineered R stent compared to the Medtronic (Minneapolis) Endeavor Sprint stent.

The study population will consist of patients aged 18 to 75 with symptoms of angina or myocardial ischemia. The primary endpoints are difference in Major Adverse Cardiac Event (MACE) rates between the two groups at 12 months following implant and 270 day angiographic Late Loss. Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, in-stent thrombosis, MACE rates at 30, 60, 90, 180 and 270 days, as well as clinically driven Target Lesion Revascularization, Target Vessel Revascularization and Target Lesion Failure rates at 30, 60, 90, 180, 270 and 360 days.

The first patient was enrolled in the study at Beijing Chaoyang Hospital on Dec. 8.

Genous is OrbusNeich's endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis, the company said.

OrbusNeich's Genous Bio-engineered R stent has been commercially available in more than 60 countries since 2005.

Misonix in Danish distribution agreement

Misonix (Farmingdale, New York) has entered into a new, three year, exclusive distribution agreement with Hemax Medical (Hvidovre, Denmark), for the BoneScalpel ultrasonic bone cutter.

The agreement provides Hemax with the rights to sell in Denmark, Norway, and Sweden, and includes minimum purchase requirements.

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. It offers the convenience and speed of a power instrument without the potential hazards associated with rotary sharps.

NovaShunt initiates PIONEER study of AFS

NovaShunt (Zug, Switzerland) reported the initiation of its pivotal multi-center clinical study, PIONEER, a perspective, open label, non-randomized study to investigate the safety and performance of the Automated Fluid Shunt (AFS) in patients with ascites and diuretic resistance.

The study is designed to evaluate the safety and performance of the AFS system in replacing the need for paracentesis, the standard therapy for patients with refractory ascites. Secondary parameters in the study are concomitant reduction in the need for medication, healthcare costs, and patients' quality of life, the company said. Data from the PIONEER study will be submitted to the Notified body to obtain CE marking, which will allow NovaShunt to enter the European market. The principal investigator of the study is Jose Such, MD, head of hepatology at the University General Hospital (Alicante, Spain), and will be initialized in five university hospitals in Europe specialized in managing patients with refractory ascites (located in Alicante, Barcelona, Frankfurt, Regensburg and London).

The AFS system is an implantable, battery powered pump designed to automatically and continuously removes excess fluid – known as ascites – that builds up in the abdominal cavity in patients with liver disease and other conditions.

SFDA approves Alex TriVantage

Candela (Walyand, Massachusetts) reported that the State Food and Drug Administration in China has approved the Alex TriVantage multi-wavelength, Q-switched laser system and the GentleMax multiple wavelength workstation for sale throughout the People's Republic of China, including Hong Kong. The receipt of the SFDA certificates will allow Candela to begin the sales process and launch official marketing programs for these products, creating a host of new market opportunities, the company noted.

The Q-switched Laser-Pumped-Laser (LPL) technology of the Alex TriVantage laser provides 755-nm, 532-nm and 1064-nm output wavelengths, making Alex TriVantage extremely versatile, according to Candela. The addition of a long-pulse mode at 755 nm offers advanced treatments for a wider variety of pigmented lesions (many unique to Asian skin) without long-term side effects. Beyond the treatment of benign pigmented lesions and the removal of multi-color tattoo inks, Alex TriVantage enhances the results of many skin rejuvenation treatments, making it an ideal system for optimizing fractional and other rejuvenation treatment results, the company said.

By integrating two of aesthetic laser medicine's leading devices, the GentleLASE and GentleYAG, into a configurable, upgradeable workstation, the GentleMax has made treatment for a wider range of patient concerns more readily available. The GentleMax laser system features both 755-nm and 1064-nm wavelengths and may be used to provide permanent hair reduction on all skin types and tanned skin as well as the treatment of vascular and pigmented lesions, wrinkle reduction and skin tightening. With GentleMax, it is now possible for one device to do the work of two or more.

SafeStitch gains CE mark for AMID Stapler

SafeStitch Medical (Miami) said it has received CE mark authorization to commercialize its AMID Stapler. The new stapler is to be used for fixation of mesh in the repair of hernia defects and also for the approximation of tissues, including skin. The AMID Stapler is the first surgical stapler designed specifically for use in inguinal hernia repairs using the Lichtenstein method, in which mesh is implanted for reinforcement. SafeStitch said in November that it had received FDA 510(k) clearance for the AMID Stapler.

ST.Jude's Merlin@home gets CE mark approval

St. Jude Medical (St. Paul, Minnesota) reported CE mark approval of its USB cellular adaptor for the Merlin@home transmitter, a system that allows important patient data from an implantable cardiac device to be wirelessly downloaded and securely transmitted via telephone for review by a physician. The new USB adaptor allows patients using a Merlin@home transmitter to transfer data to their physician over the cellular network, in addition to the existing landline service previously available.

The USB cellular adaptor is a small device that plugs into new and existing Merlin@home transmitters. The transmitter typically sits on a patient's bedside table and wirelessly communicates with the patient's device during the night. Regularly scheduled follow-up appointments and daily device checks occur without any patient interaction required. This connectivity allows patients to limit the need for unnecessary visits to their physician's office, but also allows physicians to more quickly become aware of any changes with the patient's condition or device.

The Merlin@home transmitter is transportable and can transmit device data from anywhere with a mobile signal or landline and electrical power. The transmitter supports all radio-frequency (RF) St. Jude Medical implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), and the Accent RF pacemaker and Anthem RF CRT-P (cardiac resynchronization therapy pacemaker). The Accent RF pacemaker and Anthem CRT-P are the first and only pacemakers that provide complete remote and in-clinic follow-ups via wireless communication. The data from these devices are transmitted from the patient to the physician via the Merlin.net Patient Care Network (PCN), an Internet-based repository of patient and device data.

Implantable cardiac devices are designed to capture and record information about device performance and patient heart rhythms that is vital to patient care. Merlin.net PCN organizes this information for fast analysis and easy review and allows data to be sent directly to a clinic's or a hospital's EHR system so the data can be included in the patient's comprehensive personal health record. Alerts can also be set up by the physician, based on their preferences, notifying them of any urgent changes with the patient's condition or device.

The company said that the data transferred using the Merlin@home device is fully encrypted and meets or exceeds all applicable national data privacy and security requirements in every country where the Merlin.net PCN is used.

Device sniffs out stomach bugs

Testing has begun on a device that can sniff out the presence of disease by smell, thanks to a £1.3 million award from the Wellcome Trust (London). OdoReader, developed by Chris Probert from the University of Bristol and Norman Ratcliffe from the University of the West of England, uses technology to rapidly diagnose Clostridium difficile, by 'reading' the odor of stool samples.

Clostridium difficile may cause severe diarrhea, especially among hospitalized patients.

With the help of University Hospitals Bristol NHS Foundation Trust, the technology enables gasses emitted from feces to be analyzed in under an hour, leading to a rapid and inexpensive diagnosis. Such early detection could reap real health benefits for millions of people and help prevent the spread of infectious disease.

The £1.3 million Wellcome Trust Translation Award will cover a three-year program of work which started last month. It will support the development of OdoReader prototypes, which will then be tested against the industry 'gold standard' method of making the diagnosis. The final produce will undergo a clinical trial before becoming available for commercialization in 2012/13.

Valtech Cardio completes $17.8M 'B' round

Valtech Cardio (Or Yehuda. Israel) reported that new and existing investors (OXO Capital Valve Ventures, NGN Biomed Opportunity II, and Peregrine VC Investments II) recently completed a Series B financing of $17.8 million.

Valtech develops minimally-invasive surgical and transcatheter mitral valve repair and replacement technologies designed to correct or significantly improve mitral valve function in ways that reduce or eliminate mitral regurgitation.

Excelsior syrninges get Canandian approval

Excelsior Medical (Neptune, New Jersey) reported that it has received a Medical Device License from Health Canada for its new, pre-filled catheter lock syringe to be sold in the Canadian marketplace.

The syringe contains the first commercially available heparin replacement solution – a combination of 4% sodium citrate and 30% ethanol in water for injection. The solution has similar anticoagulant properties to heparin so it helps maintain catheter patency without the possible negative side affects.

The new Excelsior solution has a major advantage over heparin, because it eliminates many of the potentially dangerous complications associated with heparin. Heparin in low concentrations has been the traditional locking solution for central venous catheters. But heparin use entails risks such as the potential for bleeding disorders, hemorrhaging due to an overdose, heparin induced thrombocytopenia, and the chances of being mixed with incompatible medications.

PPD's Singapore lab earns CAP accreditation

PPD (Wilmington, North Carolina) reported that its global central lab operations in Singapore has earned accreditation by the College of American Pathologists (CAP), validating its ability to deliver high-quality, reliable data that meet the highest standard of excellence in enhancing patient safety and speeding drug development.

The Singapore facility is PPD's fourth central lab to achieve accreditation by the CAP Laboratory Accreditation Program.

PPD opened its Singapore central lab last year in response to growing client demand in Southeast Asia. PPD also operates central labs in Highland Heights, Kentucky, Beijing, China, and Brussels, Belgium.

TomoTherapy now in Australia, New Zealand

TomoTherapy (Madison, Wisconsin) said it is expanding into Australia and New Zealand. The company recently signed a distribution agreement with Nucletron (Veenendaal, the Netherlands) and was awarded a contract by Queensland Health to supply the first TomoTherapy treatment system in Australia to Royal Brisbane & Women's Hospital (both, Brisbane, Australia).

Nucletron is TomoTherapy's exclusive distribution partner in Australia and New Zealand.