BB&Ts

If cancer doctors had a crystal ball they could peer into and know whether or not a particular patient's cancer will spread, it would take the guesswork out of choosing which treatment option is best. For now, the next-best thing may be the discovery of a new breast cancer marker associated with metastasis that may lead to the development of a tissue test to predict the likelihood of metastasis via the bloodstream.

In a small, case-control study, researchers at New York-Presbyterian Hospital/Weill Cornell Medical Center (New York) have linked the density of the new marker, called Tumor Microenvironment of Metastasis (TMEM), with the development of distant organ metastasis via the bloodstream. According to the authors, that is the most common cause of death from breast cancer. They also noted that about 40% of breast cancer patients relapse and develop metastatic disease and that roughly 40,000 women die of metastatic breast cancer every year.

"Currently, anyone with a breast cancer diagnosis fears the worst – that the cancer will spread and threaten their lives. A tissue test for metastatic risk could alleviate those worries, and prevent toxic and costly measures like radiation and chemotherapy," says senior author Joan Jones, MD, professor of clinical pathology and laboratory medicine at Weill Cornell Medical College and director of Anatomic Pathology at New York-Presbyterian Hospital/Weill Cornell Medical Center.

In the study, investigators performed a retrospective analysis of tissue samples from 30 patients with invasive ductal carcinoma of the breast who developed systemic, distant-organ metastases. These samples were compared to matched controls that had breast cancer that did not spread. The samples were compared by size of the tumor, differentiation of the tumor (how it looks under a microscope compared to normal breast tissue), and other factors, Jones told Biomedical Business & Technology. All patients were female and underwent primary resection of their breast cancer at New York-Presbyterian Hospital/ Weill Cornell Medical Center between 1992 and 2003.

The researchers found that TMEM density was more than double in the group of patients who developed systematic metastases compared with the patients with only localized breast cancer. Also, they found that in well-differentiated tumors, where the outcome is generally good, the TMEM count was low.

"If patients can be better classified as either low risk or high risk for metastasis, therapies can be custom tailored to patients, preventing over-treatment or under-treatment of the disease," said first author Brian Robinson, MD, resident in anatomic pathology at New York-Presbyterian Hospital/Weill Cornell Medical Center.

The Integrative Cancer Biology Program of the National Cancer Institute funded the study. Because the analysis was done on a very select group of patients, Jones said the findings would have to be validated in a larger sample group before the test could be rolled out.

The Weill Cornell investigators set out to build on previous research by co-author John Condeelis, PhD, of the Albert Einstein College of Medicine (Bronx, New York). Working in animal models, he identified a link between blood-borne or systemic metastasis and a three-part association between invasive carcinoma cells, perivascular white blood cells (macrophages) and the endothelial cells that line vessel walls. To confirm this finding in humans, Jones and Robinson developed a triple immunostain for human breast cancer samples that simultaneously labels the three cell types that together they named TMEM.

Elsewhere in the product pipeline:

BioTronik (Berlin) reported the global launch of the new Biotronik Home Monitoring. The system is based on more than eight years of experience in remote monitoring technology and extensive research among both physicians and patients. Biotronik says the home monitoring is available across the entire product portfolio of pacemakers, ICDs and cardiac resynchronization therapy (CRT) devices allowing physicians to remotely monitor their patients' clinical and device status at any time and from anywhere in the world.

Covidien (Boulder, Colorado) reported the U.S. launch of the Puritan Bennett 540 portable ventilator. The ventilator runs on a lithium-ion battery that provides up to 11 hours (depending on settings and other factors) of power and features a real-time battery life indicator that is a significant technological advancement. The indicator displays remaining battery life in hours and minutes, instead of as a percentage of charge, eliminating guesswork about when the ventilator needs to be connected to a power source for recharging. The portability, long battery life and ease of use of the Puritan Bennett 540 ventilator enables a ventilator-dependent patient to pursue daily activities with confidence and peace of mind, ultimately enhancing quality of life.

DePuy Spine (Raynham, Massachusetts) said it has begun testing of a genetically engineered human protein in patients with moderate to severe low back pain. The first in a series of clinical studies evaluating the safety and effectiveness of the protein, intradiscal rhGDF-5 (recombinant human growth and differentiation factor-5), began at Texas Back Institute (Plano). The study outcomes will evaluate if injections of rhGDF-5 into the lower spine can relieve pain and slow or even reverse early stage degenerative disc disease. The study consists of patients who have had persistent discogenic back pain for at least three months at one symptomatic lumbar level from L3/L4 to L5/S1 and who have not responded to conservative medical treatment such as physical therapy. Clinical outcomes will be measured using standard validated tools and lumbar disc changes will be measured using magnetic resonance imaging data.

Ekahau (Reston, Virginia), a provider of Wi-Fi-based Real Time Location Systems (RTLS), reported that it will make available a family of small, mobile battery-powered transmitters, called Ekahau location beacons, to further increase the location accuracy of its Wi-Fi RTLS solution. These beacons are designed to enhance system performance in areas that have poor Wi-Fi coverage but where location accuracy is critical.

GE Healthcare (Waukesha, Wisconsin) reported the introduction of its new Carescape telemetry platform, a wireless patient monitoring offering for hospitals. Built on GE Carescape Enterprise Access and leveraging GE ApexPro CH Telemetry, GE Carescape telemetry enables hospitals to simultaneously leverage multiple telemetry frequencies and coordinate cell phone, Wi-Fi and other wireless technologies on one infrastructure. The Carescape provides dual-band capabilities enabling hospitals to simultaneously leverage the two protected frequency bands – 600 MHz and 1.4 GHz – in Wireless Medical Telemetry Service (WMTS) with a single, central telemetry system. Hospitals can monitor up to 438 patients while ensuring that critical patient data is sent securely without interference.

Invatec (Bethlehem, Pennsylvania) received FDA clearance to market its Amphirion Deep 150 mm Long PTA Balloon and Tapered 210 mm Long PTA Balloon in the U.S. The 150 mm and Tapered 210 mm Long Balloons are indicated to dilate stenoses in the femoral, popliteal and infra-popliteal arteries, while sharing the same unique design and quality features as the rest of the Amphirion Deep product line. The unique Tapered 210 mm Long Balloon is anatomically-designed to provide more precise balloon-to-vessel conformability in the narrowed and tapered distal regions of the leg and foot.

Innocoll (Ashburn, Virginia) said that its subsidiary, Innocoll Pharmaceuticals, has filed a 510(k) application for its CollaRx Lidocaine Sponge for the management of painful wounds. The CollaRx Lidocaine Sponge is a lyophilized collagen sponge containing purified type-I collagen protein and lidocaine, a locally acting anesthetic. The product is intended to be used for the management of painful wounds including: diabetic ulcers, venous ulcers, pressure ulcers, ulcers caused by mixed vascular etiologies, full-thickness & partial thickness wounds, abrasions, traumatic wounds, 1st and 2nd degree burns and dehisced surgical wounds.

Inverness Medical Innovations (Waltham, Massachusetts) said that it will begin marketing and distributing the new C. Diff Quik Chek Complete rapid test as an in vitro diagnostic aid for Clostridium difficile associated disease (CDAD). This follows Techlab's (Blacksburg, Virginia) recent clearance from the FDA to manufacture the product for Inverness. C. difficile is responsible for the most common form of hospital-acquired diarrhea and antibiotic-associated colitis.

Invitrogen (Carlsbad, California) reported the launch of the GIBCO OptiCHO Protein Express Kit, an integrated solution for development of serum-free, stable cell lines for biotherapeutic development. This kit provides cells banked under cGMP conditions, enabling biotherapeutics manufacturers to speed regulatory submissions and time to market. The GIBCO OptiCHO Protein Express Kit enables biotherapeutics manufacturers to develop stable cell lines where proteins of therapeutic interest can be expressed and reproduced. It uses all of the reagents, protocols and documentation required to go from gene to stable cell clones expressing the protein of interest within a completely serum-free process. All of the products within the workflow are animal-origin free, which supports biomanufacturers' ability to enhance the safety of human therapeutics.

LDR (Austin, Texas) said that it received FDA clearance to market its ROI-A implant as an anterior lumbar interbody fusion (ALIF) device. Previously cleared as a partial vertebral body replacement, the ROI-A system incorporates the VerteBRIDGE screwless plating technology. The ROI-A ALIF is a stand-alone implant system with zero profile, self-locking plates designed for initial and long-term stability. The surgical technique is a direct anterior approach, with the curved plates inserted along the sagittal plane thus requiring no additional exposure to the vertebral bodies. The system is comprised of multiple footprint sizes, lordotic angles and heights for optimized fit per anatomical requirements. An innovative inserter holds the implant, protecting vascular structures and guiding the plates during insertion.

Medtronic (Minneapolis) began the international launch of the Driver Sprint RX Coronary Stent System, which received the CE Mark in February 2009 and is planned to be commercially available in more than 100 countries worldwide. The new system incorporates a new tip design for a low profile and an enhanced shaft design which together greatly improve the device's deliverability. These innovations are also incorporated in Medtronic's Endeavor Sprint and Resolute Drug-Eluting Stent Systems.

Merge Healthcare (Milwaukee), a medical imaging solutions provider, reported the addition of Fusion Hosted RIS/PACS and Fusion Hosted PACS solutions to its portfolio of managed services. These new "software as a service" solutions provide a cost-effective alternative for healthcare organizations seeking to create a more efficient digital environment for patient images and information. A pay-per-study model provides affordable and easy access to the newest releases of Merge Healthcare's digital imaging software solutions with minimal on-site IT management of the system.

Microtest Laboratories (Agawam, Massachusetts) said that it is adding dissolution testing to its current suite of analytical testing and stability services. Dissolution is a compendial method used to measure a drug's rate of release from its dosage form. It is a complement to other analytical assays – potency and related substances – that characterize the dosage form. Dissolution is typically used to optimize drug delivery rate during development studies; for use in routine QC analysis for lot release and to measure lot-to-lot variability; for use in stability studies to study the effects of time/temperature/humidity on the dosage form; and to compare one dosage form to another (different formulations, different processes, analysis of competitor's samples).

Motion Computing (Austin, Texas) said that the F5 rugged tablet PC and the C5 Mobile Clinical Assistant (MCA) are available for use on the Verizon Wireless mobile broadband network. Also, Motion reported upgrades to the devices including enhanced performance, the latest WiFi technology and a new 64GB solid state drive (SSD) option. Motion's C5 and F5 tablets are compliant under the Verizon Wireless open development program, which is designed to offer businesses and consumers the ability to use wireless devices, software and applications not offered by the company on its nationwide wireless network. With access to mobile broadband from Verizon Wireless integrated into the Motion C5 and F5, users can access email, download files and browse the Internet at broadband speed. Upgrades to the C5 and F5 include expanded communications capabilities with the Intel WiFi Link 5300 series 802.11 a/g/draft-n, Intel Centrino technology with the Intel Core2 Duo processor for improved performance and battery life, and a new 64GB SSD upgrade.

Orthovita (Malvern, Pennsylvania) said that it has submitted additional data to the FDA in support its 510(k) filing for the use of its Cortoss bone augmentation material in vertebral augmentation. This 510(k) application is intended to demonstrate that the performance of Cortoss is substantially equivalent to polymethylmethacrylate bone cement. Cortoss is an injectable, polymer composite that mimics the structural characteristics of human bone.

Royal Philips Electronics (Andover, Massachusetts) reported several enhancements to the HeartStart MRx, a monitor/defibrillator for advanced life support-trained caregivers in the emergency medical services and hospital environments. The HeartStart MRx now includes new clinical decision support tools, updated data management solutions and next-generation Q-CPRTM technology that can be used by a healthcare system as part of a program to improve cardiac care.

• Solos Endoscopy (Boston) said it has developed a new endocoupler with an eye piece for the MammoView system. Along with its current endocoupler, it will allow the MammoView scope to be used by a majority of the video systems currently in the market place. Solos has already started to market the new endocoupler to those customers that previously could not utilize the standard endocoupler.

• Sonic Innovations (Salt Lake City) introduced its first receiver-in-canal device, Sonic Touch. Sonic Touch is offered at three technology levels and available in a choice of five base colors and 15 accent color clips. "The Sonic Touch product represents a major step forward for Sonic Innovations and our industry as a whole. In addition to its sophisticated design, incredibly small size and ease of use features, Sonic Touch has the best moisture resistance of any RIC product on the market," said CEO Sam Westover.

St. Jude Medical (St. Paul, Minnesota) and GE Healthcare (Waukesha, Wisconsin) reported the worldwide commercial launch of the first fully integrated wireless solution for the measurement of Fractional Flow Reserve (FFR). The new FFR solution, integrated into existing cathlab infrastructure, will enable physicians and cathlab staff immediate access to FFR measurement without time consuming setup. The solution is based on the PressureWire Aeris technology and an FFR upgrade package available for the XT and XTi system configurations of GE's Mac-Lab hemodynamic recording system, a system used to record and display physiological parameters in the coronary cathlab. PressureWire Aeris was developed and marketed by Radi Medical Systems (Uppsala, Sweden), was by St. Jude in December .

• SymCare Personalized Health Solutions (West Chester, Pennsylvania) said that the FDA has cleared the new inTouch diabetes program to support effective diabetes management. The new web-based system uses a combination of objective biometric data, education and a rewards program to better engage patients in effective diabetes management. The system offers patients a network of support and customized education and information while providing healthcare professionals with objective biometric data for more specific and personalized patient/ healthcare professional interaction.

• SunTech Medical (Morrisville, North Carolina) reported the newest release of AccuWin Pro v3 ambulatory blood pressure monitoring (ABPM) software. AccuWin Pro v3 software supports SunTech's Oscar 2 ambulatory blood pressure monitor. The release offers various upgrades including new compatibility features for Windows Vista and integrated USB communications.

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