Short of a cure for diabetes or a drug therapy that serves to simulate a cure, the best near-term hope for fighting off the ravages of diabetes is currently in the hands of the device sector of med-tech. That hope is the creation of a system linking real-time continuous sensing and monitoring of a person’s glucose level, with this monitoring then activating a pump system that delivers insulin in exactly the right amounts. Referred to as a “closed loop” system, this combination of devices would be most advanced when totally implanted and requiring only occasional maintenance.
Given the complexity of the disease and the various metabolic requirements that are involved, however, this particular “Holy Grail” of medicine is probably still years away. But last month two companies unveiled FDA approvals that serve to point in the direction of the closed-loop system.
The first of these was early-stage firm DexCom (San Diego) with a three-day sensor, with the approval of its device followed closely by Medtronic Diabetes (Northridge, California), subsidiary of the tech titan Medtronic (Minneapolis), with that company claiming even a further advance in its technology.
DexCom received FDA approval for its STS System consisting of a tiny wire-like sensor that the patient can, himself or herself, insert just under the skin. The sensor continuously measures glucose levels, with the data transmitted wirelessly to a cell phone-like Receiver. With the push of a button, the hand-held Receiver provides the patient with real-time glucose measurements and trends, as well as providing auditory and vibratory alarms of high and low glucose levels. Significantly, the FDA approval came much before the company expected it, the agency skipping its approval-letter-first-final-approval-later but rather going straight to approval.
Adjunctive to the fingerstick regimen those with diabetes must follow, the DexCom sensor was approved for monitoring over three-day periods, and the company said it will later seek an approval for use over a seven-day period. Besides alerting the user to highs and lows in glucose ranges, the sensor is especially useful in warning against these problem events during the night, when such attacks can happen without the person able to respond – and occasionally resulting in death.
As if not to be one-upped by the smaller start-up – which immediately parlayed the approval into an announcement for an initial public offering – Medtronic Diabetes unveiled approval of its three-day sensor, bannering it in somewhat incorrect fashion as the first to be “integrated.”
While the term integrated will very much tend to suggest that the closed-loop system has been achieved, this is not the case for the MiniMed product. Its “integration” is in the ability of the sensor to send signals to a pump and, according to the company, tell it exactly the amount of insulin to be delivered. But the pump doesn’t automatically do the delivery. Rather, the patient still must activate the pump. Additionally, like the DexCom sensor, the system is also adjunctive to the required daily fingersticks.
Both approval announcements were followed by press statements from the Juvenile Diabetes Research Foundation (JDRF; New York), which hailed the developments as steps toward the ultimate “artificial pancreas” of the closed loop sort, emphasizing their ability to control wide swings in blood sugar.
Aaron Kowalski, PhD, director of strategic research projects for JDRF, said that such devices offer “a huge difference” to those with many of those with diabetes and that his organization is interested in these advancements, from whatever company. He noted that JDRF is itself funding a research program focused on this at Yale University (New Haven, Connecticut), led by Bill Tamborlane, PhD. He said that the Yale group has developed a system of the closed-loop variety and with it produced “preliminary data that is unbelievable, extremely exciting to me.” This effort is pushing forward using off-the-self products, primarily the Guardian RT (real-time) sensor from Medtronic MiniMed (Northridge, California) and a Medtronic insulin pump, Kowalski noted.
Kowalski emphasized the inadequacy of much of the current technology used to control diabetes. Some studies, he said, have found that even those patients who were intensively managing their disease – measuring their glucose an average of nine times a day – spent less than 30% of the day in normal glucose range. The rest of the time their glucose was either too high, or too low. He said studies have found that patients using continuous glucose sensors spent 26% more time in normal glucose range and have statistically significant improvements in HbA1c levels, an important measure of longer-term glucose control.
In other products news:
• Acacia Research (Newport Beach, California) said that its CombiMatrix group has launched the ElectraSense Influenza Typing System based on CombiMatrix’s electrochemical detection technology and its Influenza A Typing Microarray. The CombiMatrix Influenza A typing microarray can identify all strains of Influenza A, including the pathogenic H5N1 strain. CombiMatrix is prepared to make this system available to domestic and international government agencies that are engaged in monitoring influenza and planning for a potential pandemic. Using this system, government agencies can verify, before disseminating potentially alarming information to the public, whether samples contain a highly pathogenic substrain of H5N1 or one of the several non-lethal substrains of H5N1. The portable system eliminates the bulk, complexity, delicate lasers, and fluorescent dyes common with existing technologies. CombiMatrix will seek FDA approval for the product.
• Angiotech Pharmaceuticals (Vancouver, British Columbia) said an article in the March 15 edition of Journal of the American Medical Association on the TAXUS V ISR (in-stent restenosis) clinical trial that found the Taxus Express2 paclitaxel-eluting stent system, made by Angiotech’s partner, Boston Scientific (Natick, Massachusetts), achieved superior outcomes in the treatment of in-stent restenosis compared to those patients treated with radiation-based brachytherapy. TAXUS V ISR showed that compared with brachytherapy, implantation of paclitaxel-eluting stents reduced the nine-month rate of target vessel revascularization from 17.5% to 10.5% and target lesion revascularization rate from 13.9% to 6.3%. The study also demonstrated an 11.5% rate of major adverse cardiac events for the Taxus stent group, as compared to a 20.1% rate for the control group.
• ArthroCare (Austin, Texas), has received FDA 510(k) clearance to market its Parallax acrylic resin cartridge with Tracers that works with the Parallax integrated delivery system (IDS), which ArthroCare acquired via its $28 million acquisition of Parallax (Scotts Valley, California) in 2004. The company said the Parallax IDS is the industry’s first fully-enclosed device used to mix and deliver bone cement during vertebroplasty and kyphoplasty procedures.
• Aspect Medical Systems (Newton, Massachusetts) has enrolled the first 20 patients in its BRITE major depression trial (Biomarkers for Rapid Identification of Treatment Efficacy in Major Depression), designed to determine if the company’s brain monitoring technology can predict the effectiveness of antidepressants after one week. Aspect President and CEO Nassib Chamoun said during a conference call with investors and media that while most patients will “eventually respond” to some antidepressant regimen, “it is often difficult for clinicians to predict who will respond to a particular drug, especially early in their treatment.” Chamoun said the BRITE trial is “an ambitious effort by Aspect and our collaborating investigators to address several important clinical issues regarding the care of patients with major depression. The scale of the BRITE trial is indicative of the challenges that are faced by clinicians and researchers in determining the best course of treatment for an individual patient.” The study is an effort to build on Aspect Medical’s use of the BIS Monitoring System for central nervous system uses other than its initial focus, the monitoring of brain activity during surgery or sedation.
• Bausch & Lomb (Rochester, New York) reported FDA approval of the company’s 100 Hertz excimer laser, the 217z100, for use as part of its Zyoptix Personalized Laser Vision Correction System for refractive surgery. The combination of beam diameters and laser speed of the 217z100 makes it among the fastest laser vision correction treatment times available in the U.S. The 217z100 laser operates at twice the speed of the Bausch & Lomb system currently on the U.S. market in both standard and custom treatment modes. The laser is expected to be commercially available in the U.S. by July, along with an upgrade path to allow current users of the Zyoptix laser to access the faster technology.
• Biotronik (Portland, Oregon), focused on cardiac rhythm management, reported FDA approval and the first implant of the newest member of its Biotronik implantable cardioverter defibrillator lead family, the Linox SD active fixation, steroid-eluting lead. The Linox SD incorporates a slim 7.8 Fr isodiametric lead body, an advanced helix mechanism, and two color-coded DF-1 connectors. Linox SD also features Biotronik ‘s fractal technology for improved sensing performance and a steroid-eluting collar to control acute threshold increases. The first U.S. implantation of Linox SD was performed at Riverview Regional Medical Center (Gadsden, Alabama) on April 10. The company said it also recently received FDA approval for the Setrox S active fixation, steroid-eluting bradycardia lead. It features a slim isodiametric profile at 6.7 Fr with the same advanced helix mechanism and flexible distal tip that provides greater maneuverability for implantation and improved post-implantation results. Both Linox SD and Setrox S offer great mapping capability that allows physicians to identify the optimal implant location prior to extension of the helix, the company said.
• Boston Scientific (Natick, Massachusetts) reported the U.S. launch of its ZIPwire Hydrophilic Guide Wire, which has received FDA clearance to facilitate the placement of devices during diagnostic and interventional procedures. The ZIPwire Guide Wire’s coating supports smooth exchanges with other devices and is designed to support crossing of difficult lesions. A flexible and refined tip is designed to allow physicians to maneuver through tortuous blood vessels and facilitates smooth catheter advancement and precise positioning. A robust nitinol core resists kinking and transmits rotation along the length of the device (torque transmission), which improves maneuverability. The ZIPwire Guide Wire is available in stiff and standard versions and in various lengths, diameters and tip shapes.
• CardioDynamics (San Diego), a developer of impedance cardiography (ICG) technology, reported publication of data from the ED-IMPACT trial, which demonstrated that information from its BioZ ICG device resulted in a change in treatment 39% of the time and a change in emergency department diagnosis 13% of the time in patients presenting with shortness of breath. The results were published online in Academic Emergency Medicine, and will be published in the print version of the journal in April.
• Cardiogenesis (Foothill Ranch, California), manufacturer of surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) procedures, reported the publication of an Expert Review of Medical Devices focused on the company’s Holmium:YAG TMR system in the March edition of Future Drugs. Author Keith Allen, MD, of the Heart Center of Indiana (Indianapolis), concluded: “Angiogenesis is the most likely mechanism of action responsible for clinical improvement following TMR, and research should be continued to find ways to augment this process.”
• A hand-held surgical probe could help surgeons obtain a clear margin during a single lumpectomy procedure, according to a report issued at the annual scientific meeting of the American Society of Breast Surgeons (Columbia, Maryland). Developed by Dune Medical Devices (Caesarea, Israel), its BP probe provides information in real time to detect differences in electrical waveforms reflected from fresh tissue specimens. The probe device and accompanying console were designed specifically for intraoperative use and, if necessary, in the lumpectomy cavity, enabling what he called data enhanced surgery. The probe works using RF spectroscopy, or spectrum measurement of the issue in the radiofrequency range of 0-1 GHz.
• Fujifilm Life Science (Stamford, Connecticut), a developer of imaging technology, reported the availability of the LAS-3000mini, a compact, super CCD luminescent image analyzer. Based on the LAS-3000, the mini offers researchers a high-performance desktop solution for luminescence applications. The compact image analysis system is designed for chemiluminescence and bioluminescence analysis, specifically for Western blotting applications. It incorporates Fuji’s super CCD chip, which allows for resolution of 3.2 to 6.3 million pixels. The LAS-3000mini also uses the newly designed F0.85 Fujinon high-sensitivity lens to capture the faintest images. The low-noise design captures images at minus 30 degrees Celsius, allowing for increased exposure times. In addition, the compact body incorporates the modular darkroom and non-parallax tray.
• GE Healthcare (Waukesha, Wisconsin) reported FDA 510(k) clearance for the Innova 3131IQ and 2121IQ digital flat panel biplane imaging systems at the American College of Cardiology (Bethesda, Maryland) annual scientific sessions held in Atlanta last week. Both systems are indicated for use in cardiovascular imaging, diagnostic and interventional procedures, and 3-D imaging of vessels and soft tissue. The Innova IQ platform is capable of imaging the finest vessels and cardiovascular anatomy based on the company’s digital flat panel technology. With the 20cm and 30cm area coverage, the Innova Biplane systems are the first to cover the full size of the patient’s lateral and frontal anatomy simultaneously, GE said.
• Gen-Probe (San Diego) reported that it has submitted to the FDA an amendment to its biologics license application for the Procleix Ultrioassay on the Procleix enhanced semi-automated system (eSAS). The Ultrioassay was developed to simultaneously detect HIV-1, hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissues. The amendment responds to questions asked by the FDA in an October 2005 complete review letter regarding the Ultrioassay. Separately, Gen-Probe reiterated that it intends to submit a 510(k) application for the fully automated Procleix Tigris system to run the Procleix WNV assay, a blood screening test for the West Nile virus, by the end of April. The WNV assay was approved by the FDA in December 2005 to run on the eSAS. The company intends to submit a 510(k) application for the Ultrioassay on the Tigris system following clearance of the system for the WNV assay.
• Hitachi America (Tarrytown, New York), a subsidiary of Hitachi, said that it has obtained FDA 510(k) clearance for its ProBeat Proton Beam Therapy System. ProBeat is a proton beam irradiation system designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Hitachi’s first U.S. ProBeat system is in its final stages of construction at the University of Texas M. D. Anderson Cancer Center Proton Therapy Center (Houston).
• Hologic (Bedford, Massachusetts) said a breast cancer research study it funded with Aid for Cancer Research (Boston) evaluated the use of Advanced Image Enhancement (AIE; Providence, Rhode Island) software for examining regions of interest with Hologic’s Lorad Selenia digital mammography system. The study reported that the AIE software allowed the radiologist to reach an opinion with more confidence in 20% to 70% of the cases studied, depending upon the radiologist. When asked to rate AIE technology on the ability of the software to improve the conspicuity and detail of calcifications, the radiologist participating in the study rated the software superior in 88% of the cases studied. The report concluded that AIE technology provided a significant advantage for improving clarity of structures in dense breast tissue.
• IRIS International (Chatsworth, California), a manufacturer of automated IVD urinalysis systems and medical devices used in hospitals and clinical reference laboratories worldwide, said it unveiled its new iChem 100 Urine Chemistry Analyzer at the Clinical Laboratory Management Association ThinkLab ‘06 conference in Charlotte, North Carolina. The iChem100 analyzer, its associated iChem Urine Chemistry Strip and the visual read vChem Urine Chemistry Strips product lines, were introduced to nearly 3,500 laboratory professionals who attended the exhibition at the Charlotte Convention Center. The iChem100 is a semi-automated, benchtop instrument designed for small clinical laboratories testing up to 50 samples per day, which include small hospitals, outpatient clinics, alternate care facilities, nursing homes and large physician offices.
• The FDA has approved a humanitarian device exemption (HDE) for fetoscopy instrument sets distributed by Karl Storz Endoscopy America (Culver City, California) under the Humanitarian Use Device (HUD) program for the treatment of fetuses with twin-to-twin transfusion syndrome (TTTS). TTTS, according to the FDA, is a rare disorder of the placenta that sometimes occurs when women are pregnant with identical twins. In TTTS, during the development of the twins, blood vessels in the fetuses’ shared placenta connect their blood circulations. In most cases, the blood flows properly through these vessels. The instrument set consists of a fetoscope, which is one of the company’s endoscopes with a light attached that is used to view the fetus. The endoscope also includes a sheath which is used to enter the abdomen of the mother through a small incision. That incision is used to pass through surgical instruments and, if necessary, any fluid. The device set is intended for use for fetuses whose gestational age is between 16 and 26 weeks.
• Masimo (Irvine, California) reported FDA clearance of the Rainbow SET Rad-57cm Pulse CO-Oximeter, a hand-held, continuous monitor that analyzes data from 8-wavelength finger sensor to measure arterial oxygen saturation, carbon monoxide, methemoglobin and pulse rate. Building on Masimo’s Rad-57 launched in 2005, the Rad-57cm adds the ability to measure methemoglobin, which compromises the blood’s ability to carry oxygen and can be life-threatening.
• Matritech (Newton, Massachusetts), a developer of protein-based diagnostic products for the early detection of cancer, said data on its point-of-care NMP22 BladderChek Test were presented at the Society for Gynecologic Investigation meeting in Toronto, showing that it detected 100% of the aggressive tumors, one of which was muscle invasive, in women with symptoms or risk factors for bladder cancer. The NMP22 BladderChek Test was also positive for seven conditions that required biopsy for diagnosis. The clinicians noted that the test has the potential to be an effective screening tool in identifying aggressive lesions early and improving prognosis in women at risk for bladder cancer. The NMP22 BladderChek Test detects elevated levels of the NMP22 protein marker in a single urine sample. The noninvasive assay is the only in-office test approved by the FDA for the diagnosis of bladder cancer.
• Mediscience Technology (Cherry Hill, New Jersey), which is developing a fluorescence-based optical biopsy platform system that uses the properties of light and its molecular interaction with tissue to aid in the diagnosis of physiological change and cancer, said that it has been notified by the FDA that its optical biopsy device (CD-R) has been classified as a non-significant risk device, and that it can commence a multicenter pilot study of CD-R for cancer detection of the cervix. The main objectives of the pilot study are to determine efficacy; the clinical sensitivity and clinical specificity by comparing the device’s real-time results to the Pap test and biopsy; and assess any adverse events.
• MediSpectra (Lexington, Massachusetts) has gotten the FDA green light for its premarket application (PMA) for the Luma Cervical Imaging System, designed to serve as an adjunct to traditional colposcopy. The device is an optical imaging system located on an “articulated arm” which is then pulled over and its light shone on the surface of the cervix in conjunction with a colposcopy exam, taking all of about 12 seconds. Then the ob-gyn completes the regular colposcopy exam, determining which areas may look abnormal. However, he checks the Luma for its results, to determine whether the ob/gyn missed any areas that may be precancerous before taking biopsies. The system scans tissue with a combination of fluorescence spectroscopy, white light diffuse reflectance spectroscopy and video imaging.
• Medtronic (Minneapolis) reported FDA clearance of expanded labeling for its cardiac resynchronization therapy (CRT) biventricular pacing systems. The labeling revision reflects new clinical benefits of Medtronic CRT systems including reduced risk of all-cause mortality and unplanned heart failure or cardiovascular hospitalization, along with previously established outcomes of patients’ reduction in NYHA Class, improved quality of life, and improved exercise capacity, among others. The FDA’s labeling expansion was based on the results of CARE-HF (Cardiac Resynchronization in Heart Failure), a landmark clinical study sponsored by Medtronic. The study results, first presented during the American College of Cardiology conference in Atlanta, and concurrently published in The New England Journal of Medicine, demonstrated that CRT reduces hospitalizations and saves lives in many patients with moderate or severe heart failure and poor heart pumping function. In the study, CRT was shown to reduce all-cause mortality by 36% and unplanned hospitalizations for worsening heart failure by 52%.
• Nanogen (San Diego), developer of advanced diagnostic products, reported that it has received FDA 510(k) clearance to market its StatusFirst CHF NT-proBNP EDTA plasma test to aid in the diagnosis of individuals suspected of having congestive heart failure (CHF). The StatusFirst CHF product results from collaboration between Nanogen and Princeton BioMeditech (PBM; Princeton, New Jersey), a rapid diagnostic test manufacturer. Nanogen and PBM have co-developed and will co-market the product. PBM will manufacture the product under contract with Nanogen. The StatusFirst CHF test is sold in conjunction with the DXpress reader, a qualitative and quantitative instrument supplied by PBM.
• North American Scientific (NAS; Chatsworth, California) CEO Michael Cutrer said the company is developing a specific device for breast brachytherapy that will allow it to enter this developing $500 million market by year’s end. The company has a multi-channel catheter that will conform to the shape and size of the tumor bed, and it’s placed through a single incision.
• NuVasive (San Diego), focused on developing products for minimally disruptive surgical treatments for the spine, reported the launch of its Gradient Plus Anterior Cervical Plating System, a next-generation enhancement of the company’s Gradient CLP dynamic cervical plate, acquired from RSB Spine in June 2005. Gradient Plus allows spine surgeons to choose, during the procedure, between three fixation options based on the surgical requirement: fixed, semi-constrained or dynamic. The company’s Controlled Translation technology incorporates variable angle screws combined with its Gradient locking system, which enables the screws to be progressively resistant to axial compression, offering a better anatomical fit. Additional features include a low profile leading edge, which translates into less soft tissue disruption for the patient. The product also includes docking guides, which improve a surgeon’s ease of drilling, tapping and screw insertion.
• Portland Orthopaedics (Sydney, Australia), a manufacturer of reconstructive orthopedic devices, said it has been granted FDA approval to sell its Beacon Primary Knee System in the U.S. The Primary Knee has been licensed from Signal Medical (Marysville, Michigan) and is used as a first-time knee replacement for patients who are the most likely sufferers of osteoarthritis and rheumatoid arthritis. The company said the implant will relieve pain and increase mobility. Manufacturing of the Beacon Primary Knee has commenced and will be the manufacturing platform for the revision knee, a niche knee product designed for people with poor bone quality who need the greater modularity and fixing capability. The revision knee is currently under development under a $1.9 million AusIndustry grant.
• Respironics (Murrysville, Pennsylvania) reported the release of the ComfortLite 2 minimal-contact nasal mask, that it said helps improve the outcomes of patients with obstructive sleep apnea through multiple cushion options and minimal contact with the face. The new Pillows Cushion offers patients a flexible pillow design that inserts slightly into the nostrils for an instant seal and easy patient set-up. The more traditional Simple Cushion rests at the tip of the nose, thus reducing pressure points at the bridge of the nose and the upper lip. Both cushions are available in sizes petite, small, medium and large. The Direct Seal cushion offers a comfortable seal and fit while resting just outside the nostrils, and comes in sizes one through six. The headgear design of the ComfortLite 2 eliminates facial pressure points and provides a reliable seal without nostril irritation. In addition, the materials and replacement parts of the ComfortLite 2 have been upgraded over the original ComfortLite to ensure durability and quality.
• Sicel Technologies (Raleigh, North Carolina) reported in mid-April that it has received FDA 510(k) clearance for its Dose Verification System (DVS), a wireless implantable radiation sensor and reader designed to help radiation oncologists know if the radiation they’re administering has hit its target. The device also provides physicians with the knowledge of how much radiation has hit the target. At this point, the DVS sensor is approved only for breast cancer, but the company said it expects to expand the indications for radiation treatment of other cancers.
• Smith & Nephew Orthopaedics (Memphis, Tennessee) reported the launch of the Journey Bi-Cruciate Stabilized Knee System, the first knee replacement system designed to restore natural knee motion. The anatomical knee system is designed to move and feel like a normal knee, and offers the additional durability of Smith & Nephew’s alternate-bearing surface, Oxinium oxidized zirconium. The system is described as “bi-cruciate stabilized” because unlike conventional knee systems, this design provides functions for both the anterior cruciate ligament and posterior cruciate ligament. The surgical technique is similar to other knee procedures, and the Journey system’s newly designed instruments allow for both minimally invasive surgery and computer-assisted surgery. The Journey knee system offers more sizing options for better fit and minimal bone resections.
• SpectRx (Norcross, Georgia) said it was granted a patent for the method in which its noninvasive cervical cancer detection technology helps to define the location of disease and reduce errors in data collection. U.S. patent No. 7,006,220 recognizes that the technology is capable of increasing the spatial resolution of changes in tissue in order to more efficiently detect diseases. The patent claims a device that spectroscopically measures tissue at a high resolution while avoiding ambiguity between measured locations, by moving a component of the device and repeating interrogations on a different set of locations of tissue using both fluorescence and reflectance spectroscopy. The method claimed allows for a short measurement time, thereby reducing potential errors while allowing the use of cost effective instrumentation, the company said.
• St. Jude Medical (St. Paul, Minnesota) reported FDA approval and launch of its next generation vascular closure device, the Angio-Seal VIP. The new device, which is approved for both diagnostic and interventional procedures, gives physicians an improved method for sealing arterial catheterization access sites. Because it provides more coverage on the artery surface than previous devices, physicians may more effectively achieve hemostasis, the company said. The device’s coated suture enhances physicians’ ability to effectively seal access sites. If physicians need to access the site a second time, they can safely re-enter with the Angio-Seal VIP device within 1 cm of the original site. All components, including a small anchor, collagen and a suture, of the Angio-Seal VIP are fully absorbed within 60 to 90 days.
• ThermoGenesis (Rancho Cordova, California), a developer of enabling technologies for cell therapy and wound care, reported that GE Healthcare (Waukesha, Wisconsin) has introduced the company’s AXP AutoXpress Platform, the first automated, functionally closed, sterile system that harvests stem cells from cord blood with high yield and high throughput. The AXP platform is designed to bring automation and precision to cord blood stem cell processing, which is today performed using manual methods. GE Healthcare acquired the global exclusive distribution rights for the AXP Platform from ThermoGenesis in October 2005, as well as the non-exclusive distribution rights for its BioArchive System, a computer-controlled cryopreservation and storage system for cord blood.
• Varian Medical Systems (Palo Alto, California) said its On-Board Imager device for delivering image-guided radiation therapy efficiently improves tumor targeting, according to a study recently published in the Journal of American College of Radiology. Using Varian’s On-Board Imager, researchers measured the time required to deliver image-guided treatments and found that the process can be smoothly and efficiently integrated into normal clinical workflow. The On-Board Imager and associated processing software were used to generate and analyze radiographic kilovoltage X-ray images prior to each patient’s treatment, compare them with reference images from the treatment plan, and fine-tune the patient’s position for treatment. The average amount of time it took to generate the images and reposition patients dropped from an initial 7 to 8 minutes when the technology was new to the clinical team to a constant 3 to 4 minutes per patient after a year’s experience.
• VisEn Medical (Woburn, Massachusetts), a provider of optical imaging technologies for biomedical research, introduced at the Academy of Molecular Imaging meeting in Orlando, Florida, the first three products in its NanoSparks line of optical imaging probes. AminoSpark680 is a super-bright and robust platform label that can be readily conjugated to a range of targeting molecules, enabling custom tailored molecular imaging in multiple disease areas. CellSpark680 is a nanoparticle label used to track the location and movement of cells in vivo, a key tool for research in cell trafficking in vivo with subsequent fluorescence activated cell-sorting analysis. AngioSpark680 is a nanoparticle probe that enables ultra-long and ultra-bright fluorescent imaging of vascularity and angiogenesis, tailored for applications in intravital microscopy. The company said the NanoSpark products will be available for sale in 2Q06 and plans to launch additional NanoSpark products later in the year.
• Demonstrating its intention to move into an expanded area of the ventricular assist device (VAD space, WorldHeart (Oakland, California) recently reported the first human implant, earlier this month, of its rotary VAD at St. Luke’s Hospital (Thessaloniki, Greece). The procedure marked the start of the company’s first-in-man feasibility study of this advanced-generation device. A surgical team, whose members had completed training at WorldHeart’s Salt Lake City facility in February, implanted the device into a 67-year-old man with advanced congestive heart failure, in conjunction with an operation that included heart valve repair as well as a coronary artery bypass graft.
• Wright Medical Group (Arlington, Tennessee), an orthopedic medical device company, has received FDA marketing clearance for use of its AlloMatrix Custom Biocomposite as a bone graft extender in the spine. The product is delivered to the customer in a freeze-dried, powdered form, ensuring that the DBM (demineralized bone matrix) proteins are preserved until mixed and prepared at the time of surgery, Wright said. The powdered DBM is combined with a high volume of large cancellous bone chips, enabling the surgeon to deliver high volumes of the patient’s own osteogenic bone marrow to the fusion site to aid in the complex bone repair cascade. In a prospective clinical study comparing lumbar fusions using an autograft from the patient’s iliac crest with AlloMatrix Custom Biocomposite combined with bone marrow aspirate and local bone, outcomes were found to be substantially equivalent. Patients treated with the AlloMatrix Custom Biocomposite are spared the additional operative time, blood loss, cost and discomfort common with the iliac crest harvesting procedure, the company said.