BB&T

A satellite-based navigation system originally intended for military applications, but made available for civilian use in the 1980s is increasingly showing up in vehicles, cell phones, sports watches and even on implantable microchips designed to reunite lost dogs with their owners. Now, FDA has cleared a GPS-like system for tracking the movement of cancerous tissue during radiation therapy for prostatectomy patients.

Calypso Medical (Seattle) said the regulatory agency cleared a new indication for the use of implantable Beacon electromagnetic transponders with the Calypso 4D Localization System — often referred to as "GPS for the Body" — in external-beam radiation therapy. Previously, the technology was only cleared for patients with an intact prostate, the company said.

"Extending the clinical use of the Calypso system is vital for post-prostatectomy patients at risk or diagnosed with recurrent prostate cancer," said Eric Meier, the company's president/CEO. "Clinicians gain increased confidence when treating these patients. This new indication broadens the spectrum of prostate cancer patients who will benefit from continuous target tracking during radiation therapy."

Meier told Biomedical Business & Technology that up to 20% of patients who have their prostate removed are later diagnosed with recurrent prostate cancer and need radiation therapy. Because radiation is not selective, he said, it is important to know exactly where the tumor is so as to avoid nearby organs and healthy tissue.

FDA cleared the 4D Localization System in July 2006. It consists of five components that work together: the electromagnetic positioning transponders which are about the size of a grain of rice, a console the size of a large rolling suitcase, and electromagnetic array to receive the transponder signals, a tracking workstation and infrared cameras installed in the treatment room.

The technology is designed to track any movement of the cancer in real time and alert the technician if the targeted tissue moves beyond pre-determined parameters so they can adjust the external beam of radiation, according to Calypso. There also is the potential for using higher doses of radiation to attack tumors while reducing the procedure time, according to Ken Russell, MD, a radiation oncology clinical chief at the Seattle Cancer Care Alliance and the University of Washington (UW; Seattle).

"The purpose of radiation oncology is to accurately deliver the treatment to the cancer and avoid as much as possible the normal nearby organs," said Russell in a statement Calypso released earlier this year. He is also vice chairman of the UW's Department of Radiation Oncology.

Meier also told BB&T that the company sees this latest FDA clearance as a step towards additional indications for the system, including breast and lung cancer. He added that the technology was all developed in-house at Calypso, which is a privately held company incubated by Frazier Healthcare and founded a little more than eight years ago.

The advantage of using "GPS for the Body," the company says, is that the radiation dose stays on target and less of it reaches surrounding healthy tissue.

Calypso says its technology addresses two major issues in modern radiation oncology: errors in treatment set-up and tumor motion during treatment.

"Patients with high Gleason scores, extracapsular extension, positive surgical margins or seminal vesicle involvement are at risk of developing biochemical failure following radical prostatectomy," said David Lee, MD, a University of Pennsylvania (Philadelphia) urologist. "These patients often need adjuvant radiation therapy. Having the benefit of continuous real-time tracking during radiation therapy is critical to minimizing possible complications associated with external beam radiation therapy. It is imperative to know precisely where the prostatic bed is located during radiation treatment. The objective tracking data, provided by the Calypso system, may be the key to achieving the desired outcomes for these aggressive cases."

The company last year reported raising $42.2 million in Series D equity financing.

Calypso's technology also got a mention last fall during a physician panel on prostate cancer at the Piper Jaffray (Minneapolis) Healthcare Conference in New York. Jeffrey Forman, MD, medical director for seven Michigan clinics in the nationwide 21st Century Oncology chain, cited the 4D Localization System, calling it "really cool technology."

Elsewhere in the product pipeline:

• Advanced Medical Optics (AMO; Santa Ana, California) reported FDA clearance of its iFS advanced femtosecond laser. The company said laser's inverted bevel-in side cut angle is designed to provide an easy flap lift, increase post-operative flap adhesion and enhance the biomechanical stability of the post-LASIK cornea. With full customization capabilities, it also produces an elliptical flap to enhance surgical options and includes IntraLase-Enabled Keratoplasty (IEK). AMO makes ophthalmic surgical devices and eye care products.

• Aethlon Medical (San Diego) said that preclinical studies have documented that the Aethlon Hemopurifier is effective in capturing circulating West Nile virus (WNV). It said that the study data further supports the potential use of the Hemopurifier as a broad-spectrum treatment against viral pathogens, whether naturally occurring, or purposely released as biological weapons of mass destruction. During in vitro studies, high concentrations of WNV (roughly 700,000 WNV/ml) were depleted from cell culture fluids when circulated through the Hemopurifier. The study data indicated that the Hemopurifier removed 535 of infectious WNV in the first four hours of the testing; 79% at six hours; and 99.3% after 20 hours. The studies were conducted in triplicate, and data verification was provided by real-time polymerase chain reaction. Aethlon specializes in making products for treating infectious disease.

• American Medical Systems (AMS; Minnetonka, Minnesota) reported the presentation of a range of studies on its GreenLight laser system at the annual meeting of the American Urological Society. Among the 20 abstracts presented, two were randomized studies concluding that photoselective vaporization of the prostate performed with the GreenLight laser is safer than, and as effective as, transurethral resection of the prostate (TURP), a common type of surgery for benign prostatic hyperplasia. AMS said its GreenLight laser, with more than 300,000 procedures performed, is a favored alternative to TURP, due to being minimally invasive, high tissue removal efficiency, quick recovery time, and rapid flow-rate with minimal side effects. The 532 nm wavelength laser provides vaporization of prostatic tissue, due to the wavelength's high absorption in oxyhemoglobin, and low absorption in water — ensuring laser energy is not lost in the procedural irrigation medium.

• Angiotech Pharmaceuticals (Vancouver, British Columbia) said it received FDA clearance for sizes 3-0 and 4-0 of its Quill self-retaining system (SRS) polydioxanone (PDO) product line. The Quill SRS PDO is an absorbable suture typically used for deeper tissue closures. These smaller-diameter sizes incorporate a new design for better holding strength and expand the number and scope of procedures that can be done with the Quill SRS product, the company said. The Quill SRS uses bidirectional fixation within the wound. Its design allows the surgeon to begin closure at the midpoint of the wound and suture in two directions from the midpoint. Barbs within the Quill SRS distribute tension across the wound and eliminate the need for knots. Angiotech describes itself as a medical device and specialty pharmaceutical company.

• Apieron (Menlo Park, California) said it has begun shipments of its Insight eNO system providing office-based measurements of exhaled nitric oxide (eNO), an indicator of airway inflammation and asthma control. With eNO measurements, physicians can adjust inhaled corticosteroid therapy to optimize asthma control and avoid exacerbations or asthma attacks. The system's biosensor technology measures eNO in parts per billion, and the disposable sensor generates a reading in less than a minute. Apieron specializes in making non-invasive measuring of eNO for asthma management.

• ArthroCare (Austin, Texas) reported results from its five-year study evaluating the effectiveness of the Topaz MicroDebrider to treat common tendon disorders, and concluded that patients who had the minimally invasive procedure were highly satisfied with the procedure and continue to experience pain relief. The Topaz MicroDebrider is a wand-like device about the diameter of a pencil tip. Through a small incision, generally an inch in length, the physician applies the device to the problem tendon for multiple 500-millisecond intervals of treatment. ArthroCare specializes in making minimally invasive surgical products.

• Atrium Medical (Hudson, New Hampshire) said it has obtained FDA approval for two new Omega 3 surgical mesh products — C-QUR Edge V-Patch and C-QUR Lite V-Patch, indicated for use in the surgical repair and reinforcement of soft tissue, including hernia repair. This technology combines Atrium's ProLite Ultra polypropylene surgical mesh with a pharmaceutical-grade Omega 3 fatty acid bio-absorbable gel coating. The company said C-QUR Edge V-Patch and C-QUR Lite V-Patch are designed to simplify umbilical, epigastric, trocar site and other small abdominal wall hernia repairs. It said the C-QUR Edge V-Patch offers long-term protection from visceral tissue attachment when placed intra-abdominally, while the C-QUR Lite version offers "superior handling and healing characteristics for a pre-peritoneal repair."

• Axis Three (Los Angeles) said that its XS-300 surgical simulation platform, a 3D imaging solution for the cosmetic surgery marketplace, is now available in the U.S. The company said the XS-300 enables surgeons to visually communicate and collaborate on the outcomes of various breast procedures by using the patient's own image presented in photo-realistic 3D. For the first time ever, accurate volumetric and linear measurements can be taken from the patient's own 3-D model, and the results of an actual surgery — breast augmentation, lift, reduction or reconstruction — can be simulated, measured and viewed from all angles. Axis Three makes surgical simulation tools.

• Baxa (Englewood, Colorado) said that is promoting its new PadLock Set Saver, an aseptic IV administration set storage solution that can be swabbed and reused. PadLock provides a secure seal for the end of the administration set, preventing contamination when the set is not being used for infusion. The Set Saver attaches to an IV administration set and replaces the need for sterile, single-use caps. The PadLock Set Saver provides temporary aseptic storage of the IV administration line when disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. Baxa makes technologies for medication handling and delivery.

• B. Braun Medical (Bethlehem, Pennsylvania) aunched three new products at a meeting of the American Association of Colleges of Nursing (Washington) in Chicago: its new IV safety infusion systems, including its Space and Outlook ES safety infusion systems, as well as the Curlin 6000 CMS ambulatory infusion system. Space is designed with both adult and pediatric facilities in mind, allows for flexibility and easy transport within a number of care settings. The Curlin 6000 CMS, an upgrade of the Curlin pain management system, comes equipped with Information On Demand technology and has flexible, syringes, bags or bottles with the pumps.

• Biocept (San Diego) said it will launch I.D. Rh(D), a series of noninvasive prenatal diagnostic tests that can be performed with a simple maternal blood sample, at the annual clinical meeting of the American College of Obstetricians and Gynecologists (Washington). The I.D.Rh(D) test diagnoses the Rh(D) status of a fetus in an Rh(D) negative pregnancy and can be performed as early as 10 weeks of gestation. The test isolates fetal DNA circulating in the mother's whole blood, using Biocept's I.D. (Isolating Fetal DNA) platform technology. The fetal DNA is analyzed in Biocept's CLIA-accredited clinical laboratory to determine Rh(D) genotype. Biocept says that I.D.Rh(D) is the only fetal Rh(D) diagnostic that identifies fetal DNA in maternal blood in all cases in which a diagnosis can be delivered-whether the fetus is male or female, Rh(D) negative or positive. This eliminates the uncertainty that can occur with other tests in which an Rh(D) negative female fetus cannot be definitively identified from the maternal blood sample. Biocept specializes in diagnostic assays. reproduction and brightness uniformity by minimizing off-angle color shift.

• Boston Scientific (Natick, Massachusetts) reported FDA approval of its Altrua family of pacemakers, following on the heals of winning the CE mark. The company says the Altrua is its most advanced pacemaker, delivering enhanced therapy with small size and battery longevity. It is the first Boston Sci-branded pacemaker to treat bradycardia - a condition when the heart beats too slowly, usually less than 60 beats per minute. The company cited a number of Altrua features: Multiple Atrial Ventricular (AV) Delay programming options, designed to reduce unnecessary right ventricular (RV) pacing, without dropping ventricular beats; Minute Ventilation (MV) Blended Sensor, treating a condition called chron-otropic incompetence, the inability of the heart to regulate its rate appropriately in response to physical activity and emotional stress; Ventricular Rate Regulation (VRR), which helps physicians manage patients with frequent atrial arrythmias; Automatic Capture, designed to offer automatic and accurate ventricular pulse management.

Boston Scientific also reported a new clinical science initiative, Altitude, which will analyze data from the Latitude patient management system. The initiative will use the substantial Latitude data to seek answers to common questions related to implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) device therapy. The Altitude initiative will be managed in collaboration with an external physician panel who will assist in identifying relevant clinical issues for examination. The company has enrolled nearly 100,000 patients on the Latitude patient management system since its introduction in 2006. The Latitude system allows phy-sicians to schedule remote check-ups of implantable cardiac devices to monitor specific device information and patient heart health status. It can also detect clinical events between scheduled follow-up visits and send relevant data directly to physicians.

• BrachySciences (Oxford, Connecticut) reported the introduction of the AnchorSeed, designed to give existing low-dose-rate prostate brachytherapy sources the ability to maintain their position within tissue, thus allowing physicians to place seeds in more strategic and beneficial locations. The company said physicians seek to be as accurate as possible re-garding seed placement without underdosing or overdosing any areas, and that AnchorSeed offers a true anchoring effect to help significantly reduce seed misalignment and seed migration. BrachySciences makes brachytherapy implants for the treatment of early stage prostate cancer.

• Cardiac Dimensions (Kirkland, Washington) said it has completed its European Carillon Mitral Annuloplasty Device European Union Study (AMADEUS), a safety and performance study of the CARILLON mitral contour system conducted at six centers in Germany, Poland and the Netherlands. The Carillon system is a percutaneous treatment of functional mitral regurgitation (FMR), currently under investigational use in Europe, South America, and Australia only. The Carillon combines an implantable device and delivery system. The implant consists of a shaping ribbon between distal and proximal anchors. The device is delivered percutaneously via jugular access under fluoroscopic guidance. The implant is designed to be positioned, adjusted and anchored in the coronary sinus/great cardiac vein to reshape the annulus around the mitral valve to reduce mitral regurgitation.

• Cardica (Redwood City, California) reported that it has filed a 510(k) application for its PAS-Port Proximal Anastomosis System, following the achievement of the primary endpoint in a large, prospective, randomized pivotal clinical trial. The trial compared the use of its proximal anastomosis system to the conventional method of using hand-sewn sutures during coronary artery bypass graft procedures. The C-Port uses "small micro staples" attaching a graft to the coronary artery, producing an anastamosis that actually pulses with changes in blood pressure. The proximal connection — with the PAS-Port Proximal Anastomosis System — is used for connection to the "garden hose"-sized aorta, as described by Newell, so attaching the graft vessel to the aorta is very different than attaching to the coronary artery via the distal connection. Put another way, this means an attachment to a vessel of 3 mm or more in diameter, using a clamping or "coupling" approach, compared to connection to a vessel of just 1 mm in diameter, using the delicate stapling method.

• LifeWatch (Buffalo Grove, Illinois) said that it has launched an atrial fibrillation (AF) care program for monitoring patients across the U.S. The company said it has now expanded its customized patient care program for the untapped market of periop-monitoring of those patients undergoing AF catheter and surgical ablation procedures. The LifeWatch AF patient care program represents the first disease state management program to be supported by the ACT service platform. LifeWatch says it has partnered with cardiac institutions to identify additional care programs in CHF and pediatrics. These programs are expected to expand ACT use and allow LifeWatch to provide a telehealth model of care that focuses on specific physician and patient needs with the goals of improving patient care and outcomes. LifeWatch is a provider of ambulatory cardiac monitoring services.

• Liko (Franklin, Massachusetts) reported the launch of a new disposable repositioning sheet, the Solo RepoSheet, designed for those patients and residents with specific needs such as isolation patients, where specific needs exist to control infection and cross-contamination, or where a method is needed consistent with current laundry control practices. The Solo RepoSheet is usually applied above the fitted sheet and below the draw sheet, but can be used in place of the draw sheet. The Solo RepoSheet is a single-patient-use sheet that should be disposed of when it becomes soiled or when the patient no longer needs it. Liko is focused on making patient-lifting equipment.

• Luna Innovations (Roanoke, Virginia) said the product development team at its NanoWorks Division has produced a class of molecules designed to provide a new approach to improve the quality of MRI. Luna's molecules have initially proven to be more effective at enhancing images and are potentially safer than current MRI agents. This new class of molecules provides a platform upon which Luna said it will build a portfolio of nanomedicines aimed at disease targeting and diagnostic imaging. The new class of molecules is called Hydrochalarone — Hydro, meaning water, combined with Chalaro, Greek for relax. The level of relaxivity is the characteristic of molecules that provides the image enhancement. Luna Innovations makes products for the healthcare, telecommunications, energy and defense markets.

• OmniSonics Medical Technologies (Wilmington, Massachusetts) said it enrolled its first patient in the SONIC II registry, a prospective, multi-center U.S. study of the company's OmniWave Endovascular System in patients undergoing percutaneous mechanical thrombectomy for acute limb ischemia (ALI). The OmniWave is a minimally invasive catheter-based technology that delivers low-power, transverse ultrasonic energy to remove thrombus. OmniSonics makes products for treatment of vascular disease.

• Optos (London) reported launch of an upgraded version of its retinal imaging software — V2 Vantage Dx — with features that include Exact Disk Optic Nerve Enhancement, 3D Wrap, and intraocular lens. Optos' devices are scalable to accommodate software upgrades. Annual upgrades are part of the company's "Evergreen Strategy" supporting customers through new business processes and software packages. Optos is a manufacturer of retinal imaging devices.

• Osiris Therapeutics (Columbia, Maryland) reported FDA clearance to initiate an expanded access treatment program for Prochymal, an the investigational stem cell product, making it available to children with life-threatening graft vs. host disease (GvHD). Prochymal, a formulation of adult mesenchymal stem cells administered through a standard intravenous line, is currently in Phase III clinical trials. Prochymal cells, a preparation of mesenchymal stem cells formulated for intravenous infusion, are obtained from the bone marrow of healthy adult donors. Osiris Therapeutics is a stem cell therapeutic company.

• PEAK Surgical (Palo Alto, California) released results from a preclinical study demonstrating that its PlasmaBlade cut freshly excised human abdominal tissue with little thermal tissue injury compared with traditional electrosurgery. The device is a low-temperature tissue dissection tool that uses pulsed plasma energy to create surgical incisions and control bleeding. In the study, freshly excised human abdominal tissue was cut using the PEAK PlasmaBlade, an uncoated traditional electrosurgery scalpel, a Teflon-coated traditional electrosurgery scalpel and a fine wire and ceramic electrosurgery scalpel. Histology samples were immediately harvested to evaluate acute thermal tissue injury. As part of the study, full-thickness skin incisions were made on porcine skin using a traditional electrosurgery device, the PEAK PlasmaBlade and a standard scalpel blade. Histological evaluation of the ex vivo human skin showed that the PlasmaBlade cuts produced minimal collateral damage compared to cuts made with the other electrosurgery instruments. PEAK makes tissue dissection systems.

• PhotoMedex (Montgomeryville, Pennsylvania) said it has received FDA clearance to market the Xtrac velocity excimer laser system to treat psoriasis, vitiligo, atopic dermatitis and leukoderma. The Xtrac delivers UV power, while retaining the efficacy of its predecessor, the Xtrac Ultra. PhotoMedex makes excimer laser and fiber optic systems as well develooping techniques directed toward dermatological applications.

• Respironics (Murrysville, Pennsylvania) and Children's Medical Ventures, a subsidiary of Respironics, reported the addition of the BiliTx phototherapy system to its line of jaundice management products for use by clinicians in the NICU, PICU, pediatrics and well-baby nursery or by parents through home care providers. In the clinical setting, the BiliTx can be configured as an overhead spotlight or connected to a fiber-optic panel in any hospital environment such as a crib or incubator. When used as an overhead spotlight, the unit's blue LED light source does not transfer heat to the baby unlike conventional halogen phototherapy devices that may require cooling fans and constant temperature regulation. The BiliTx was developed to eliminate the need for bulb replacement and reduce operating and maintenance costs. BiliTx's blue LED photon engine light source can last up to 50,000 hours. Children's Medical makes clinical and educational products supporting developmentally appropriate care for infants.

• Spectranetics (Colorado Springs, Colorado) said that a peer-reviewed study demonstrates the company's SLS II excimer laser sheath safely and effectively assists removal of pacing and defibrillator leads. The study, "Large, Single-catheter, Single-operator Experience with Transvenous Lead Extraction: Outcomes and Changing Indications," was featured in the April issue of the journal Heart Rhythm. The conclusion demonstrates safe extraction of leads successfully removed with laser assistance. The SLS II laser sheath uses use "cool" ultraviolet light to safely, effectively and efficiently ablate scar tissue that holds problematic leads in place. A circle of fibers that emit pulses of energy travel over the cardiac lead toward the tip to dissolve scar tissue that binds the lead to the body. Once the scar tissue is dissolved, the lead can be safely removed.

• Spinal Restoration (Austin, Texas) said the FDA has approved an IDE pilot study of the Biostat disc augmentation system. The Biostat consists of Biostat Biologx fibrin sealant, a human derived, biologic tissue sealant and a proprietary application system designed to safely deliver the biologic to the intervertebral disc. The Biostat disc augmentation system has been specifically developed to address chronic low back pain resulting from degenerative cracks and fissures which form within the intervertebral disc. This condition, called internal disc disruption, has been identified as the source of chronic low back pain in up to 40% of patients. Spinal Restoration specializes in spine health management.

• Competitive Technologies (CTT; Fairfield, Connecticut) said that it has applied for 510(k) clearance for U.S. sales of its pain management therapy device. The CTT product is a non-invasive method for rapid treatment of high-intensity oncologic and neuropathic pain, including pain resistant to morphine and other drugs. The pain management device uses a multi-processor designed to create self-like neurons by applying surface electrodes to the skin to simultaneously treat multiple pain areas. Aris Despo, executive VP of business development, said the device has been used successfully on over 2,000 patients in seven hospitals in Europe. "Upon FDA approval, our initial sales focus will be on hospitals, pain clinics, hospice centers and pain management specialists." CCT is a technology transfer and licensing provider.

• Connect Imaging (Honolulu, Hawaii) released a new version of its Mammo ViewBox software to support a super-high-resolution mammography display from Totoku Electric (Japan). CEO Philip Manly said the company's mammography workstation software is the first to support the ISD technology of the Totoku MS51i2 digital mammography display. "Totoku developed a novel way to triple the resolution of its 5 MP (megapixel) monitor, but taking advantage of the higher resolution required some software changes," Manly said. "Though it works most efficiently when combined with other mammography modules in the Connect Imaging PACS, our Mammo ViewBox workstation software is compatible with any DICOM archive." Connect Imaging makes customizable picture archiving and communication systems.

• Cordis (Miami Lakes, Florida) reported U.S. launch of the SLEEK and SAVVY long PTA balloon dilatation catheters, its percutaneous transluminal angioplasty (PTA) balloon catheters. The SLEEK balloon is one of the first .014" guidewire compatible rapid-exchange balloons fully dedicated to infra-popliteal vessels, while the SAVVY long balloon provides an .018" guidewire compatible over-the-wire alternative for both superficial femoral and infrapopliteal arteries. With balloon lengths up to 220 mm, the SLEEK and SAVVY balloons may enable physicians to treat long, diffuse lesions with fewer inflations and faster procedures compared to traditional PTA balloons, Cordis said. Cordis makes interventional vascular and gastroenterology technology.

• CoreSpine Technologies (Minneapolis) reported the expansion of its platform technology for spinal implant procedures to include an application for minimally invasive fusion. The development of Core-Spine's initial prototype concentrated on generating a complete and selective nucleus removal device. The technology was recently expanded to incorporate a cartilage removal device for endplate preparation. CoreSpine is focused on developing a platform technology to produce surgical devices for the complete or selective removal of material from the lumbar disc space.

• Covidien (St. Louis) reported FDA approval of a new contrast delivery system that integrates radio frequency identification (RFID) technology to provide a set of checks and balances to prevent human error in computed tomography procedures. Covidien's contrast delivery system combines its Ultraject prefilled contrast media syringes with its Optivantage DH power injectors to provide, it said, "the only RFID-enabled contrast delivery solution available in North America." The RFID automatically captures, stores and transmits data between the Ultraject syringe and the Optivantage DH power injector using RFID transponders, or tags.

• CryoLife (Kennesaw, Georgia) reported the first implant of its combination aortic-mitral allograft heart valve in a patient at the Cleveland Clinic. The method used to process the combination aortic-mitral human heart valve was developed by CryoLife in collaboration with the clinic. The valve was developed as a replacement option for patients with infective endocarditis involving both the aortic and mitral valves. Infective endocarditis is a condition in which the structures of the heart, particularly the heart valves, are infected. "Infections involving both the mitral and aortic valves put patients at very high risk for serious complications that can result in death," said Jose Navia, MD, a cardiac surgeon with the Heart and Vascular Institute at the Cleveland Clinic. "With the new human tissue combination aortic-mitral heart valve, we are hoping to provide an infection-resistant treatment option to offer patients." CryoLife makes im-plantable living human tissues for use in cardiac and vascular surgeries.

• DePuy Spine (Raynham, Massachusetts) reported the launch of the Expedium PEEK rod system, a load-sharing posterior instrumentation system designed to increase anterior column loading and support the interbody fusion process in the thoracolumbar spine. The rods shift compressive axial forces from the posterior elements to the interbody fusion site, more closely reproducing the normal loading characteristics of the lumbar spine. The rods also decrease forces on the bone screw interfaces compared to more rigid metal rod constructs. The Expedia rods are made of PEEK-OPTIMA, a biocompatible polymer of polyetheretherketone (PEEK), which provides strength and flexibility for load sharing spinal instrumentation applications. Expedium rods are available in standard 5.5 mm and 6.35 mm diameters and feature round geometry, reducing construct profile compared to larger diameter, oval shaped PEEK rod implants. DePuy Spine, a business of Johnson & Johnson (New Brunswick, New Jersey), focuses on addressing spinal pathologies.

• Draeger Medical (Telford, Pennsylvania) reported release of Innovian anesthesia version 2.2. Enhancements to the product were based on physician feedback and include expanded capabilities for IT performance in the perioperative suite, according to Draeger. Web API provides programmatic read/write access to Innovian anesthesia data that is stored within the centralized system database. Version 2.2 enables access to Holding and PACU data in addition to supporting customized stored procedure calls that may be used for data mining or other cross-case data analysis. These new additions also are provided for use by the PreOp eForms product, which supports the creation of web-based documents similar in presentation to existing hospital paper forms.

• Dune Medical (Caesarea, Israel) said that its MarginProbe device reduced repeat surgeries in breast-conserving procedures, according to a study presented at the recent annual meeting of the American Society of Breast Surgeons (Columbia, Maryland) The MarginProbe uses radio frequency spectroscopy technology to intraoperatively assess the malignancy status of tumors at the resection margin. If lumpectomy margins are identified as positive, physicians often re-shave the excision site during the initial procedure sparing patients the risk, trauma and expense of additional surgeries. The MarginProbe is comprised of a sterile hand-held probe and portable console. When the probe tip is applied to an excised lumpectomy segment, radio frequency signals are transmitted into the tissue and reflected back to the console where they are analyzed using a specialized algorithm to determine tissue status. Dune makes devices for tissue characterization.

• Facet Solutions (Logan, Utah) reported completion of a scientific evaluation for a total joint reconstruction in the lumbar spine, analyzing the combination of the company's anatomic facet replacement system (AFRS) with a semi-constrained disc replacement device in a finite element model. Facet developed the AFRS to provide patients with lumbar spinal stenosis and facet degeneration, a motion preserving alternative to lumbar spinal fusion. The AFRS procedure in-cludes replacement of the diseased facet joint with an anatomic implant that restores the natural motion, stability, and balance to the lumbar spine. Facet makes spinal implants.

• GE Healthcare (Waukesha, Wisconsin) said it has received FDA clearance for the 3.0T MRI scanner. The Signa MR750 3.0T was introduced at the International Society of Magnetic Resonance in Medicine (Berkeley, California) in Toronto. The Signa MR750 features a RF transmit system maximizing performance with a 17% gain in scanning efficiency. The system also includes the GE-exclusive Optical RF technology that adds up to 27% higher signal-to-noise ratio over conventional, non-optical MR receivers by reducing electrical noise and increasing signal detection.

GE Healthcare also reported FDA clearance of the LightSpeed CT750 HD, which it billed as the "world's first high-definition CT scanner." GE engineers said they discovered that, by changing the molecular structure of real garnets, they could develop a scintillator capable of delivering images 100 times faster, with up to 33% greater detail through the body and up to 47% greater detail in the heart. They had un-locked the secret of the GE gemstone detector, which the company touts as the fastest primary speed in the CT industry. Gemstone spectral imaging uses up to 2496 views per rotation (a 2.5x increase) to deliver im-proved spatial resolution and improved image quality across the entire field of view. Dual energy fast kV switching registers energies at least 165 times faster than Dual Source CT at a .33s rotating speed. It offers 128 slices of unique data per rotation and 101 user selectable energy levels for viewing. GE Healthcare makes medical technologies that help treat cancer, heart disease, neurological diseases, and other conditions.

• Globus Medical (Miami) reported the completion of enrollment in its SECURE-C cervical artificial disc IDE study. The SECURE-C device is designed to mimic the normal motion of the spine in order to alleviate pain and restore function as an alternative to fusion in the treatment of symptomatic cervical disc disease. "The SECURE-C implant was designed specifically to mimic the physiologic behavior of the natural healthy spine," said Joseph Marzluff, MD, a Charleston, South Carolina, neurosurgeon who has enrolled patients in the trial. "The device [offers] distinct advantages over currently available devices and a simple surgical technique that is easier than traditional plate and screw insertion. We can clearly see the clinical advantages of restoring motion to the cervical spine with our patients, particularly with the device's unique articulating surfaces and translation feature that helps them to regain previously limited motion." Globus manufactures spinal implants.

• Health Discovery (HDC; Savannah, Georgia) reported clinical trial results for its molecular diagnostic test for prostate cancer, licensed exclusively to Clarient (Alisa Viejo, California). The initial clinical validation study completed recently by Clarient from prostate tissues obtained in collaboration with M.D. Anderson Cancer Center (Houston) demonstrated a high success rate for identifying the presence of Grade 3 or higher prostate cancer cells (clinically significant) in prostate cancer tissue. HDC said the test also demonstrated a high success rate for correctly identifying those prostate specimens that did not have prostate cancer as being negative for prostate cancer and achieved a specificity of 80% for identifying the non-cancer tissues, which included normal and benign prostatic hypertrophy tissue, as not having genomic evidence of cancer. HDC and Clarient now will move to Phase II of the clinical trial process to increase the number of specimens tested in order to achieve the statistical significance necessary to validate these initial results. HDC specializes in pattern recognition technology.

• HeartWare (Sydney, Australia/Framingham, Massachusetts) reported receiving FDA Investigational Device Exemption approval for the its Left Ventricular Assist System (LVAS). The company said it will immediately begin its U.S. clinical trial for the LVAS for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure. HeartWare makes miniaturized implantable heart pumps.

• HepaLife Technologies (Boston) said that new tests of its bioartificial liver device demonstrate the company's bioreactor system and PICM-19 cells show ability to mimic important human liver function with highest levels of liver-specific metabolic activity over 14 day period. Intended for the treatment of liver failure, the HepaLife bioartificial liver device consists of three basic components: a plasma filter, separating the patient's blood into blood plasma and blood cells; the bioreactor, a unit filled with the PICM-19 liver stem cell line which biologically mimics the liver's function; and the HepaDrive, a perfusion system for pumping the patient's plasma through the bioreactor while controlling gas supply and temperature for best possible performance of the cells. HepaLife makes cell-based medical technologies.

• InspireMD (Tel Aviv, Israel) reported continued positive results from the ongoing MGuard coronary stent first-in-man, multi-center trial in Germany. This study aims at establishing the safety and efficacy of MGuard coronary sent in high-risk patients with complex lesions. The study's primary end point demonstrated zero major adverse cardiac events after 30 days in 60 patients, with 100% procedural success rate. The MGuard is a bare-metal stent merged with an embolic protection device, the latter comprised of an ultra-thin polymer mesh protective sleeve, wrapped around the stent. The protective sleeve is made of a micron-level-fiber knitted mesh, engineered in an optimal geometric configuration and designed for utmost flexibility while retaining strength characteristics of the fiber material. The sleeve is designed to expand seamlessly when the stent is deployed, without affecting the structural integrity of the stent, and to prevent plaque detachment during and post procedure. The sleeve is designed to diffuse stent pressure on the vessel wall, thereby reduce injury and lower the likelihood of restenosis. InspireMD specializes in stent platform technology.

• The Spinal Unit (Memphis, Tennessee) of Medtronic (Minneapolis) reported receiving ap-proval to market two smaller kit sizes of Infuse bone graft for use in certain spinal fusion and dental regenerative procedures. The FDA has approved two additional configurations of Infuse bone graft: XX Small (0.7 cc) kit and X Small (1.4 cc) kit. Infuse bone graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. Implanted into a bone-deficient site, Infuse works with the body's own biology to induce normal bone formation.

• NEC Display Solutions of America (Chicago) has introduced the 30-inch MultiSync MD304MC widescreen display LCD display projector, designed exclusively for the needs of medical diagnostic professionals. The four-megapixel color display is certified for radiology and emergency room environments, and includes patented technologies designed to make work easier and more accurate. The MD304-MC uses in-plane switching technology which offers color reproduction and brightness uniformity by minimizing off-angle color shift. Off-angle viewing is important in medical settings, where colleagues are asked to validate diagnosis as they stand to the side of the computer user. NEC makes commercial and personal LCD and plasma displays and projectors.

• Nipro Diabetes (Miramar, Florida) has introduced the Amigo insulin pump that helps control blood glucose for children and adults with Types 1 and 2 diabetes. The Amigo features computer-like help screens and mimics the pancreas by delivering basal insulin throughout the day and night and allowing the wearer to program bolus insulin whenever needed. It uses rapid-acting insulin that is very similar to the insulin produced by the human pancreas. The Amigo is also a smart pump because it is capable of calculating bolus insulin for food and high blood glucose readings through parameters prescribed by the physician and stored in the pump. Nipro makes diabetes products and supplies.

• Nuance Communications (Burlington, Massachusetts) has introduced version 5.0 of its Dictaphone PowerScribe for radiology speech-enabled reporting solution, which it says enhances and integrates enhancements geared to improve the radiology workflow process, via accurate, comprehensive and readily available clinical documentation. Features of the PowerScribe include enhanced voice recognition that reduces word error rate by 35%, workflow engine enhancements, system technology upgrades, and a new graphical user interface. Nuance is a developer of speech solutions.

• Omnicell (Austin, Texas) introduced SafetyMed, a point-of-care solution that extends medication from Omnicell's automated medication dispensing system to the patient's bedside. The system integrates the company's new SafetyMed bedside point-of-care software with a "smart" mobile cart for re-duced medication errors. SafetyMed is accessed through a secure web browser via a hospital's wireless network and is designed to verify medication and patient accuracy prior to administration through features that are integrated with Omnicell's medication dispensing systems. It uses bar code technology to validate real-time medication order details while confirming patient and medication identity.

• St. Jude Medical (St. Paul, Minnesota) reported the U.S. launch of the TigerWire steerable guidewire. The newest member of its Medical GuideRight family of steerable guidewires, the TigerWire is designed to enhance physicians' ability to steer through challenging peripheral arteries, the vessels that supply blood to the legs and arms. The TigerWire's tip is designed with enhanced flexibility to aid in navigation through the vessels. Its supportive design provides distinct zones of flexibility that make it easier for physicians to track and position the guidewire through challenging anatomy. The insertion of a guidewire is a first step in interventional procedures in which physicians thread catheters through the arteries to diagnose the severity of disease or deliver treatments, including devices such as stents that open blockages and restore blood flow.

• TAH Industries (Robbinsville, New Jersey) reported the introduction of the u-TAH Nano system, a single-use packaging and applicator system to use the mechanical, ergonomic, and economic benefits of standard single-component dispensers for mixing and applying two-component adhesives, pastes and other dental and medical materials in clinical applications. Potential applications for the u-TAH Nano system include packaging, mixing and applying a wide range of two-component materials such as self-cure and dual-cure dental materials, surgical sealants and adhesives, audiology impression materials, and orthopedic cements. TAH makes disposable plastic mixers and cartridge dispensing systems, meter mix dispense valves and accessories.

• Volcano (San Diego) reported participation in the Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN (SATURN) trial. This is the first pharmaceutical trial allowing physicians to use the Volcano Revolution 45 MHz IVUS imaging catheter as part of the protocol. The study by AstraZeneca is designed to measure the impact of Crestor (rosuvastatin) 40 mg and atorvastatin (Lipitor) 80 mg on the progression of atherosclerosis in high-risk patients. SATURN will compare the effects of these two statins on the ability to decrease progression or induce regression of atherosclerosis, the main cause of cardiovascular disease, following two years of treatment in patients with coronary artery disease. Volcano specializes in the diagnosis and treatment of coronary and peripheral vascular disease.