BB&T < and Staff Reports

The Rinecker Proton Therapy Center (RPTC; Munich, Germany) reports encouraging preliminary results for a new lung cancer treatment using the proton therapy systems supplied by Varian Medical Systems (Palo Alto, California).

In Munich, a large tumor in the right upper lung of a 75-year-old patient was reduced by 50%, thanks to 18 proton therapy treatments over three months, the Rinecker center reported.

Manfred Herbst, medical director at RPTC, said he expected to further reduce this tumor with subsequent treatments.

For a second patient with cancer in the left lung, Herbst reported a clear reduction of the tumor volume and a significant improvement in breathing after eight treatment days, while healthy tissue in the same lung and the right lung were unaffected by the high-energy treatment and free of radiation.

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 advanced treatment technique used at RPTC - called pencil beam scanning – enhances precision by enabling clinicians to maximize dose to the tumor while minimizing dose to nearby sensitive organs and tissue.

The proton energy has a predictable drop-off which enables oncologists to deposit the peak of the energy within the tumor and reduce the exposure to the surrounding healthy tissue.

The center's operator, ProHealth (Munich, Germany), expects to treat 4,000 patients a year at RPTC and reports that from the moment the doors were opened earlier year it has been overwhelmed with inquiries that far exceeded capacity.

RPTC enthusiastically predicts that “under favorable conditions, this number may be increased to 5,000 patients a year,“ yet the center, which originally expected to open in 2005, has faced only unfavorable conditions.

Varian took over the troubled project in 2007 with the acquisition of Accel Instruments (Bergisch Gladbach, Germany).

After untangling the complex engineering issues it inherited from Accel, Varian was then stymied in commissioning of the gantries for the five treatment rooms as problems cropped up in the software 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).

“As a result, we decided to limit press relations to a minimum and keep a low profile,“ said Joerg Hauffe, MD, CEO of ProHealth, adding that with its limited therapy capacity the center currently is offering medical appraisals for inquiring patients to inform them whether they can hope for a timely treatment or should seek an alternative therapy.

As of July the €150 million ($209 million) RPTC reported treating 250 patients from 23 countries.

A Varian spokesperson told BB&T that gantries in three treatment rooms have been successfully commissioned.

A fourth treatment room with a similar 360-degree targeting gantry is “currently being commissioned and will be brought into use very shortly,“ the spokesperson said.

The company said it expects to commission in November 2010 the fifth and final treatment room with a fixed-beam gantry to irradiate delicate head, neck and eye cancers or tumors close to the spinal cord.

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.

The Varian spokesperson said the company will “announce subsequent deals – ProHealth or otherwise – as soon as we can.“

“I can say that Varian has been named as preferred supplier to proton projects that are being planned in Delft, the Netherlands, and in Maestra, Italy,“ said the representative.

European centers report results from Varian

Varian's Oncology Systems group made a strong showing recently in Barcelona, Spain at the annual meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO; Brussels, Belgium), reporting both clinical and commercial successes for novel radiotherapy technologies.

Following the presentations of research findings for its RapidArc technology, Varian reported the first clinical evidence and a second installation of its newer TrueBeam system.

Introduced in April as the first fully-integrated system designed to treat a moving target tumor, the TrueBeam platform for image-guided radiotherapy and radiosurgery delivers specified radiation doses with greater precision in fewer, higher dose fractions than with conventional radiotherapy.

Results from treatments at Zurich University Hospital (Zurich, Switzerland), the first medical center to bring the novel technology online, were presented during an Emerging Technologies symposium at ESTRO.

In the same session, clinicians from the Vrije Universiteit Medical Center (VU Medical Center; Amsterdam, the Netherlands), which began clinical treatments the week previous using the TrueBeam system, discussed results for an 80-year-old lung cancer patient who underwent the radiotherapy using the new linear accelerator.

A second TrueBeam system is being installed at VU Medical Center and is expected to begin clinical operation in November.

Varian reports 10 European centers are installing the technology including the Institut Catala d'Oncologia in the ESTRO host city of Barcelona.

In addition to the new linear accelerator, TrueBeam integrates technologies that dynamically synchronize imaging, patient positioning, motion management, and treatment delivery.

Masimo wins Japanese clearance of SpHb

Masimo (Irvine, California) reported the Japanese Ministry of Health, Labor and Welfare (MHLW) regulatory clearance of its noninvasive and continuous hemoglobin (SpHb) measurement, available as part of the Masimo rainbow SET platform. Representing a breakthrough solution for noninvasively and continuously measuring a patient's hemoglobin level in real-time, SpHb tracks and trends hemoglobin levels without needles, time-consuming laboratory analysis, and risk of contamination associated with traditional blood tests, the company said.

The availability of noninvasive, continuous, and immediate hemoglobin measurements is expected to have wide-ranging clinical impact in Japan – from surgery and intensive care units to less acute care settings, including the emergency department and physician offices. SpHb may help clinicians determine whether a patient has a low hemoglobin level and facilitate prompt detection of internal bleeding and more appropriate administration of blood transfusions – by referring to the SpHb measurement that is continuously displayed on Masimo rainbow SET Pulse CO-Oximeters.

Z-Medica in Finnish distribution for QuikClot

Z-Medica (Wallingford, Connecticut), a company developing hemostatic agents, said it has signed an exclusive distribution agreement with Fenno Medical (Helsinki, Finland). The agreement allows Fenno the exclusive right to distribute Z-Medica's QuikClot line of hemostatic agents to the hospital and emergency medical services (EMS) markets throughout Finland for the first time.

QuikClot products received the CE mark last November and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors since then.

QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/GYN, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (Combat Gauze) was chosen as the exclusive product for use by all U.S. military forces in 2008.

WMT unit signs Panamanian distribution deal

Wound Management Technologies (WMT; Fort Worth, Texas) said that its subsidiary, Wound Care Innovations (WCI), signed a distribution agreement with Bivium to distribute its advanced wound care collagen product, Cellerate RX in Panama. The addition of Panama now puts WCI's distribution channels in six countries in Central America, to include Belize, El Salvador, Honduras, Nicaragua and Guatemala.

WMT says its primary focus is the distribution of its collagen product, Cellerate RX.

Medtronic DBS system gets CE mark for epilepsy

Medtronic (Minneapolis) has received CE mark approval for its deep brain stimulation (DBS) therapy in Europe as adjunctive treatment for partial-onset seizures in adults with medically refractory epilepsy. DBS therapy for epilepsy delivers controlled electrical pulses to a target in the brain called the anterior nucleus of the thalamus, which is part of a circuit involved in seizures.

The CE mark approval was based on data collected in Medtronic's clinical trial called SANTÉ (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy). The SANTÉ trial was a prospective, randomized, double-blind pivotal study to evaluate the use of DBS therapy for patients with medically refractory epilepsy with partial-onset seizures. The trial collected data from 110 patients who were implanted with a Medtronic DBS system at 17 U.S. centers.

Medtronic will be introducing its DBS therapy for epilepsy in expert epilepsy centers across Europe by the end of the year. The therapy is investigational in the U.S. and is under FDA review. According to the company, the FDA recently requested additional data to support Medtronic's PMA application, which will require further clinical study.

Gore launches delivery system for Excluder

W. L. Gore & Associates (Flagstaff, Arizona) reported the first clinical uses of the GORE C3 delivery system to deploy the Gore Excluder AAA endoprosthesis as a minimally invasive treatment for patients suffering from an abdominal aortic aneurysm (AAA). The Gore C3 delivery system provides surgeons and interventionalists with added deployment control with the ability to reposition the Gore Excluder Device, increased confidence while treating challenging anatomies, and cannulation options with the ability to bring the contralateral gate to the contralateral guidewire.

Gore says the C3 delivery system provides physicians with a proven stent graft and delivery options that they never had before. The Excluder remains virtually unchanged, maintaining the same low delivery profile and flexibility on catheter that facilitates access and passage through narrow and tortuous anatomies, the company noted. Once delivered into the aorta, the delivery system enables repositioning of the stent graft during the procedure. The ability to reposition the device can minimize complications that could occur were the graft to be positioned incorrectly during the initial deployment. This technology was designed to give physicians a second or third opportunity to accurately place the stent graft relative to the patient's anatomy.

Trinity transapical aortic valve implanted

Transcatheter Technologies (TT; Regensburg, Germany), a medical device company that is developing a second-generation transcatheter aortic valve prosthesis, reported that its transapical aortic valve has been implanted in the acute porcine model.

TT said its repositioning system allows for complete expansion of the valved stent and full evaluation of prosthesis' function before repositioning, before retrieval, and before final release.

“Our aim is to remove the risks and anxiety associated with current transcatheter valve implantation procedures. Trinity's true repositioning technology allows the user to fully expand and anchor the valve, then evaluate hemodynamic valve function before separating from the catheter,“ said Hou-Sen Lim, CTO. “Our proprietary pre-mounted valve technology removes the need to mount the valve onto the catheter system in the operating room prior to the procedure, thereby reducing the cost and eliminating the risk associated with mounting the valve by an assistant at the implantation side.“

SI-Bone anticipates iFuse CE mark at 'anytime'

SI-Bone (San Jose, California), a company developing a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint said it is launching training for its iFuse Implant System and anticipates CE mark “at anytime.“ The company introduced the system at the Eurospine meeting in Vienna last month.

SI Bone has already received ISO 13485 certification, it noted.

European surgeon training sessions are scheduled for October and November in Salzburg, Austria.

The iFuse system is comprised of titanium implants coated with a porous plasma spray that acts as an interference surface fit, which helps decrease implant motion. According to the company, the iFuse has a substantial thickness and sophisticated metallurgy, which provide immediate post-operative fixation, accomplishing the goal of traditional open SI Joint fusion through an MIS approach.

“The CE mark will allow our EU team to develop a presence in selected EU markets to address the needs of physicians committed to treating patients with SI joint problems,“ said Jeff Dunn, president/CEO of SI-Bone. He added that the company “looks forward to entering these markets because we offer the only technology which provides an MIS solution to treat these SI joint conditions.“

The iFuse is indicated for use in fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

U-Systems wins CE mark for somo-v

U-Systems (Sunnyvale, California) reported winning approval to market its somo-v automated breast ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer in the European Union.

“This represents a major advancement in breast health for women as study after study have demonstrated a need for additional tools to improve the early detection of breast cancer, particularly in women with dense breast tissue which impacts detection and carries an increased risk of breast cancer,“ said Ron Ho, president/CEO of U-Systems. He added that the system is not intended as a replacement for mammography, “which remains the most effective screening tool for many women.“

U-Systems is sponsoring the SOMO INSIGHT study, designed to evaluate whether digital mammography in combination with the somo-v is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with greater than 50% dense breast tissue. To date, more than 9,000 women have participated in the study, which is actively recruiting up to 20,000 women at multiple breast imaging centers in the U.S.

Rainer receives CE mark for Cadisc-L

Ranier Technology (Cambridge, UK) says it has received CE mark approval for its Cadisc-L, an elasto-mimetic spinal disc replacement device for the lumbar spine. The approval was received following a review of the company's multi-center European study and its “extensive portfolio“ of biocompatibility and biomechanical testing, Ranier noted.

“The initial outcomes in the clinical study are very pleasing. By using the Cadisc-L spinal disc replacement, we found patients had significant reductions in average leg and back pain, and overall disability, and coupled with an increase in quality of life there are very strong indications of early phase performance,“ said Ian Quirk, director of clinical and regulatory affairs at Ranier.

Cadisc-L is intended to treat degenerative disc disease of the lumbar spine.

Zargis, OTN to promote telemedicine stethoscope

Zargis Medical (Stamford, Connecticut) has signed an agreement with the Ontario Telemedicine Network (OTN) providing for the delivery and testing of Zargis' telemedicine stethoscope system.

An independent, not-for-profit organization funded by the Government of Ontario, Canada, OTN provides access to care for patients in every hospital in Ontario and hundreds of other healthcare locations across the province. In 2010 OTN says it will conduct more than 100,000 patient visits over more than 2,000 telemedicine systems.

The core component of Zargis' telemedicine stethoscope system, Zargis TeleSteth, is a component of the Zargis Cardioscan heart sounds analysis software and the Zargis StethAssist heart and lung sounds visualization software. TeleSteth was developed to extend the practice of auscultation (listening with a stethoscope) to situations and environments where face-to-face encounters are not always convenient or feasible. This platform allows healthcare professionals to share heart, lung and airway sounds with colleagues located across the globe using the Internet or a private network. TeleSteth permits patient sounds to be remotely evaluated in real-time (synchronous) or store-and-forward (asynchronous) mode.

TeleSteth is designed to be accessed from a user's PC via a standard Internet browser. Additionally, for organizations requiring users to access stethoscope sounds from within their private network, TeleSteth can be deployed using Zargis' secure enterprise server platform. All components of Zargis' telemedicine stethoscope system are HIPAA-compliant.

Defibtech gets Canadian marketing okay

Defibtech (Guilford, Massachusetts) reported approval from Health Canada to market the Lifeline View AED device. The Lifeline View AED offers a full-color interactive display that shows users step-by-step how to perform CPR and external defibrillation.

Sudden cardiac arrest (SCA) is a leading cause of death in the U.S. and Canada and affects 35,000 to 45,000 Canadians each year. The only cure for most cases of SCA is immediate shock therapy from an AED, which shocks a lifeless heart back to a normal rhythm.

The Defibtech View AED is the newest addition to the Lifeline AED family of products, which have been sold in Canada since 2005. The device is lightweight and durable and was designed in response to the need to make AEDs as easy to use as possible.