Boston Scientific (Natick, Massachusetts)used Digestive Disease Week last month to report worldwide commercial availability of its SpyGlass Direct Visualization System for single-operator duodenoscope-assisted (SODAC) — that lengthy description boiling down to mean visual examination of the bile ducts.
According to the company, the SpyGlass requires only one physician operator, providing unprecedented, direct visualization of all bile-duct quadrants. SpyGlass is designed to provide four-way steerability and dedicated irrigation channels in addition to a 1.2 mm working channel through which diagnostic and therapeutic devices can be used. “The primary benefit is that one physician can do this,” Len Farris, a global marketing director for Boston Scientific, told Biomediocal Business & Technology.
Farris said the SpyGlass system provides the opportunity for a more definitive diagnosis of digestive diseases, which leads to earlier treatment. Direct visualization of the biliary system (via cholangioscopy) has been possible for more than 30 years and its benefits are well documented in numerous published studies, the company says. However, it says that the technology has not been widely adopted due to the cost and limitations of available devices.
SpyGlass System was designed to help GI endoscopists overcome these hurdles and to make cholangioscopy feasible for a larger number of physicians. Direct visualization with the SpyGlass System potentially offers significant procedural and clinical advantages over conventional Endoscopic Retrograde Cholangiopancreatography (ERCP), according to the company.
ERCP is used to diagnose and treat “challenging” conditions of the bile ducts and pancreas, such as removing gallstones, opening obstructed bile ducts and obtaining biopsies in suspected tumors. With conventional ERCP, physicians use an endoscope to view the entrance to the biliary tract while access to the ducts is gained with small catheters passed through the scope’s working channel.
Visualization is achieved by injecting contrast media and taking X-rays of the treatment area. However, the resulting flat, 2-D, black and white images often do not provide sufficient information to obtain a complete diagnosis, according to Boston Scientific. Estimates indicate that at least 30% of ERCPs performed using brush cytology or biopsy forceps for tissue acquisition result in the need for additional testing, the company said.
If ERCP is insufficient to make an adequate diagnosis, or therapeutic intervention requires direct visualization into the bile ducts, the physician may choose to perform cholangiopancreatoscopy.
Historically, this procedure has required two endoscopists, one to operate the therapeutic duodenoscope (mother scope) and another to steer the cholangioscope (or baby scope) and to operate its working channel. Thus, conventional cholangiopancreatoscopy has failed to gain widespread adoption as a solution because available systems are labor-intensive, and include instrumentation commonly viewed as fragile and difficult to manipulate.
SpyGlass, Boston Scientific says, overcomes the shortcomings of both conventional ERCP and currently available peroral cholangiopancreatoscopy systems, enabling a single physician to potentially secure a definitive diagnosis and perform therapeutic intervention in one procedure.
The SpyGlass System uses a miniature 6,000-pixel fiber-optic probe that attaches to a camera head. The probe is inserted through a single-use access and delivery catheter that can be steered in four directions to access and inspect the treatment area. The system attaches directly to a standard duodenoscope, eliminating the need for a second physician operator.
Elsewhere in the product pipeline:
• 3D Systems (Rock Hill, South Carolina) reported plans to introduce a compact, fast, low-cost hearing aid manufacturing system based on its new Film Transfer Imaging (FTI) technology, the V-Flash HA 230 manufacturing system, this fall. The HA 230 Desktop manufacturing system can build high-quality, three-dimensional hearing aid shells within hours. Dreve Otoplastik, a hearing aid and materials manufacturer, will be the distributor for the V-Flash HA 230. The V-Flash weighs about 100 pounds. 3D Systems provides 3-D modeling, rapid prototyping and manufacturing solutions.
• AccSys Technology (Pleasanton, California) reported that the company’s first mobile PULSAR PET Isotope Production Laboratory has been sold and shipped for the rproduction of fluorodeoxyglucose (FDG) and other compounds in a hospital-based molecular imaging program. It consists of a lightweight proton linear accelerator (linac) installed in a mobile coach of Mobile Coaches outfitted with a laboratory containing a shielded mini-cell for housing a synthesis unit for FDG and a clean area with a Class 3 laminar flow hood for dispensing. The mobile accelerator and laboratory, which can be moved and set up quickly, aboids the geographic constraints of the present heavier accelerators, setting “a new standard for the local delivery of short lived PET,” AccSys said. PULSAR PET Isotope Production Systems are based on the light-weight, rugged technology used in all AccSys rf ion linac systems. AccSys manufactures and services compact ion linacs using its patented linac technology.
• Avantis Medical Systems (Sunnyvale, California) reported receiving FDA clearance for its Third Eye Retroscope auxiliary endoscopy system. The retroscope is an imaging device used during colonoscopy to provide an additional view that can reveal polyps, cancers and other lesions that might be missed during a standard colonoscopy procedure. The retroscope is passed through the instrument channel of a standard colonoscope until it extends beyond its tip. As it emerges, the device automatically turns around 180 to aim back toward the tip of the colonoscope. Then, as the colonoscope is withdrawn, the Third Eye follows along to provide a continuous retrograde view of the colon. This retrograde view complements the forward view of the colonoscope and may reveal abnormalities that are hidden behind folds and flexures. Avantis makes catheter-based endoscopic devices.
• Baxter Healthcare (Deerfield, Illinois) reported results of a Phase I study that evaluated pulmonary insulin produced with Baxter’s Promaxx microsphere technology and administered using a small, standard dry powder inhaler. The study demonstrated that the insulin powder can be effectively administered to the deep lung using an off-the-shelf dry powder inhaler designed for upper airway drug delivery. Each study subject received in randomized fashion a single dose of 10 International Units of insulin through subcutaneous injection (SC) in one period, and 6.5 milligrams of the inhaled insulin microspheres, called recombinant human insulin inhalation powder (RHIIP) in the other period. Study data show that RHIIP had a faster onset of action than SC. The bioavailability of RHIIP relative to SC was more than 12%. Baxter Healthcare, a subsidiary of Baxter International, makes products to assist treatment of complex medical conditions including hemophilia, immune disorders, kidney disease, cancer, trauma and other conditions.
• BD Diagnostics (San Diego) reported that it has submitted to the FDA, for 510(k) clearance, the first assay for the rapid and simultaneous identification of methicillin-sensitive Staphylococcus aureus (MSSA) and methicillin-resistant Staphylococcus aureus (MRSA) from patients with positive blood cultures. This assay will enable physicians to implement the right treatment at the right time for patients with bloodstream infections, transforming patient care and significantly reducing healthcare costs. The BD GeneOhm StaphSR assay is a test that is performed directly from positive blood cultures. BD specializes in improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines.
• Cook Urology (Spencer, Indiana) introduced a line of resection electrodes for urological procedures such as transurethral resection of the prostate (TURP) and transurethral resection of bladder tumors (TURBT). Cook says it offers five different types of electrodes compatible with all major brands of resectoscopes. The electrodes enable prostatic or bladder tissue removal with minimal bleeding, increased visibility and decreased procedure time. Cook Urology is a division of Cook Medical (Bloominton, Indiana).
• Diagnostic HYBRIDS (Athens, Ohio) reported the release of its D3 IFA enterovirus identification kit for the qualitative identification of enteroviruses in cell culture by immunofluorescence. The kit, for in vitro diagnostic use, utilizes a blend of monoclonal antibodies developed in-house. These antibodies target enterovirus-specific antigens produced after a relatively short incubation period in the company’s enterovirus cell system called Super E-Mix, or conventional cells such as primary monkey kidney cells. The D3 kit represents a product design improvement on current identification protocols that employ a non-specific, cellular induced protein that is not induced specifically by enteroviruses. Diagnostic HYBRIDS makes diagnostic and analytical products for a wide range of viral respiratory diseases, herpes virus infections, and other specific viral and thyroid diseases.
• Diamics (Novato, California) reported that it has begun high-volume manufacture of its CerCol cervical sample collector. The initial GMP qualification run passed inspection and met product specifications. This allows production to commence so that Diamics can recognize revenue from its recently signed $22 million contract with the Bejing Jingmin Hospital Group. Diamics’ representatives in China have moved forward with the CerCol registration. The hospital group has agreed to purchase the CerCol collectors and use them within their own facility as well as sell them to their affiliates to support the country’s focus on improving women’s health care. The CerCol is intended for the collection of cervical cytology material and its transfer for Pap analysis. The new device demonstrated > 98% sample adequacy in multi-center clinical trials and offered patients greater comfort over conventional collector devices. Diamics is a privately held company developing products for cancer screening and diagnostics.
• Draeger Medical (Telford, Pennsylvania) reported the launch of its newest ventilator, the Carinahome, into the U.S. market. The Carinahome’s design enables caregivers to support patients’ ongoing conditions away from clinical settings. The Carinahome, with its pressure- and volume-oriented modes, has proven itself equally effective in and out of the clinical environment, and presents both professional and non-medical caregivers with their own interfaces. The user interface concept means that while a full-access interface is available, showing both pressure and flow curves, a dedicated patient-friendly screen enables patients to adjust pre-determined settings according to their personal needs. Draeger makes products assisting emergency, perioperative, critical, perinatal, and home care.
• Eclipsys (Boca Raton, Florida) reported that PowerBANK Enterprise Edition has received FDA 510(k) clearance. PowerBANK is Eclipsys’ solution for automating the functions of a hospital’s blood bank and is a component of Eclipsys sunrise laboratory. PowerBANK automates the processes from receipt of blood products to monitoring blood products and patient results as well as issue and transfusion documentation. It provides functionality for complete product inventory management and includes reports capabilities on receipt, release and results of blood products. PowerBANK also supports the U.S. industry consensus standard for the uniform labeling of blood and blood components using ISBT 128 by using bar coded entry. Eclipsys makes integrated information software, clinical content and provides professional services that help healthcare organizations.
• E-Z-EM (Lake Success, New York) reported receiving FDA 510(k) clearance for its EmpowerMR injector system, its first product for the MRI market. EmpowerMR uses features dealing with the problem of electrical interference in the magnetic field of the MR scanner. MRI systems create powerful magnetic fields and require the use of non-magnetic materials and components in the immediate surroundings of the scanner. Electromechanical devices like injector systems can create both electric and magnetic fields that cause electrical interference with the scanner during the imaging process, leading to image distortion or artifacts. EmpowerMR uses a hydraulic control system instead of the shielded electrical control components used by most other MR injectors systems. EmpowerMR has no shielded iron core motors, piezoelectric motors or electrically active motor control circuitry adjacent to the scanner, hence minimizing the prospect of electrical interference with the scanner’s magnetic field. EmpowerMR provides for utilization in MR field strengths up to 7 Tesla. E-Z-EM makes contrast agents for gastrointestinal radiology.
• Fluidigm (South San Francisco, California) has introduced the BioMark system based on nanofluidic chips, for real-time PCR, known as dynamic arrays, and with advantages compared to 96-well plates, including: 24 times the number of PCR assays per run, reductions in reagent costs, and less liquid-handling complexity to implement large-scale studies. The system also runs BioMark digital arrays, which enable “digital PCR” — a term describing detection of nucleic acid mutations in a high background of similar sequences. Fluidigm makes systems based on the properties of integrated fluidic circuits to control fluids on a nanoliter volume scale.
• Hamilton Thorne Biosciences (Beverly, Massachusetts) said it has received third-round FDA marketing clearance for additional clinical applications for its ZILOS-tk zona laser drill. It says that the drill is the only non-contact laser device to be awarded marketing clearance for zona-pellucida drilling for blastomere biopsy and trophectoderm biopsy of human embryos in clinical applications. Laser-assisted biopsy with the ZILOS-tk uses a highly focused laser beam to remove the zona pellucida in very precise increments. Laser-assisted biopsy requires less handling of the embryo than these other biopsy methods. Also, laser-assisted biopsy is faster than the other methods and, therefore, the embryo spends less time outside the incubator. Hamilton Thorne is a private technology company that supplies computer-based solutions to the infertility, drug discovery, and animal production markets.
• HealthTronics (Austin, Texas) reported launch of its LithoDiamond ULTRA lithotripter. The LithoDiamond ULTRA has five key clinical features: technology which provides both electrohydraulic, or “spark gap” therapy delivery, as well as electromagnetic therapy delivery; a rotating therapy head that provides unencumbered access to both sides of the patient for treating kidney and lower ureteral stones in either the supine or prone position; integrated iso-centric C-arm and image chain which provides optimal image quality to visualize stones in the kidney and ureter; mobile platform consisting of two components for excellent portability and productivity; and table functionality that allows for cysto, prostate and other surgical procedures. HealthTronics makes urology services and products.
• Ichor Medical Systems (San Diego) reported receiving FDA approval to conduct a Phase I clinical trial of a melanoma vaccine to be administered to patients utilizing a novel delivery technology. The vaccine consists of DNA encoding a form of the tyrosinase protein. The vaccine will be administered with the Ichor TriGrid delivery system (TriGrid), which uses electroporation to increase the intracellular delivery of the DNA vaccine to the cells at the site of administration. The design of electrodes and DNA injection needle in the TriGrid yields consistent placement of electroporation pulses where DNA is administered in the target tissue. The automated one-step push-of-a-button process controls the rate of DNA injection and the time interval between injection and electroporation application. Ichor, a privately held biotech company, makes products based on the in vivo application of electroporation to enhance intracellular delivery of DNA drugs encoding therapeutic proteins or antigens for vaccines.
• Mentor (Santa Barbara, California) reported FDA approval of an amendment to its MemoryGel silicone gel-filled breast implant post-approval study (PAS) protocol addressing patient enrollment. Responding to feedback from institutional review boards and physicians concerning the restriction of patient access to an approved device, the company said that the FDA approved the amendment to the PAS protocol to a voluntary patient enrollment design, allowing those patients who choose not to or cannot participate in Mentor’s PAS the opportunity of selecting Mentor’s MemoryGel implants for their surgery. Mentor is a supplier of medical products for the global aesthetic market.
• Nanogen (San Diego) reported submitting a 510(K) application to the FDA for its cystic fibrosis kit and NanoChip 400 microarray system. The cystic fibrosis kit is to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. The genetic assay screens for 23 mutations which account for approximately 90% of cystic fibrosis cases in the U.S. Caucasian population. The NanoChip 400 instrument is an automated multiplexing platform that laboratories use to detect genetic sequences. Tests can be performed using reagents supplied by Nanogen or laboratories can develop a variety of “homebrew” assays. The NanoChip employs Nanogen’s core microarray technology, which utilizes patented microfluidics and electronic technology to automate sample handling and detection of results. Nanogen produces diagnostic products.
• A study published in the Journal of Child Neurology indicates that a treatment from Medtronic (Minneapolis) for spasticity in children with cerebral palsy improves their quality of life and is cost-effective, compared to other established cost-effective treatments. Medtronic said that the findings of the study should expand access to the treatment, known as Medtronic ITB therapy (Intrathecal Baclofen Therapy). The most common form of cerebral palsy involves spasticity, tight, stiff muscles that make coordinated movement of the arms and legs difficult or uncontrollable. Medtronic ITB therapy, which uses the company’s SynchroMed implantable infusion system to deliver a muscle relaxant directly to the fluid-filled area surrounding the spinal cord, can reduce severe spasticity with fewer side-effects than oral medication.
• NeuroLogica (Danvers, Massachusetts) reported launch of its CereTom OTOscan in-office computed tomography scanner optimized for otolaryngology. The OTOscan provides the images of both bone and soft tissue. The CereTom OTOscan is revolutionizing ear/nose/throat treatment options by enabling the patient scans directly during office visits, avoiding the need to refer patients to an imaging facility to receive ENT diagnostics. The OTOscan is a portable eight-slice CT scanner that acquires 1.25 mm slices per rotation. It is 29 inches long, about five feet tall and four feet wide and weighs about 750 pounds. The system’s battery can be recharged in any standard wall outlet and holds enough power to image four to eight patients. The scanner also includes a mini-PACS system that is ideal for use in the physician’s office. NeuroLogica is a neuroscience-based medical imaging company.
• Sonic Innovations (Salt Lake City) introduced Velocity, its new digital hearing aid product family at the American Academy of Audiology National Convention and Exposition. The systems offered in Velocity give hearing impaired consumers the ability to use their hearing aids “hands-free.” Using environmental sound cues, Velocity is able to automatically adjust the hearing aid settings to best meet the challenges of a particular listening situation, without requiring the wearer to press a button. Velocity features patented digital signal processing and advanced noise reduction, patent-pending adaptive directional technology, automatic directionality, adaptive feedback cancellation and several advanced user options, including patient-friendly voice alerts and automatic telephone listening settings that are activated when a conventional telephone is held to the ear. The company also introduced the ion 200, an open behind-the-ear product, at the The ion 200 technologies combine to automatically adjust the hearing aid as the consumer’s listening environment changes. Sonic Innovations makes digital hearing aids.
• SonoSite (Bothell, Washington) reported a major advance in image resolution for the MicroMaxx system together with a series of enhancements to improve clinical workflow. The fifth major technology expansion to the MicroMaxx platform since the system began shipping in mid-2005, the new capabilities include SonoMB technology, a proprietary multi-beam imaging algorithm that dramatically improves image resolution. Also included are advances in fundamental and harmonic imaging for abdominal applications, automated image optimization, and credentialing worksheets for recording exams in emergency medicine. Existing customers can upgrade their MicroMaxx systems to the new capabilities via compact flash card at no charge. SonoSite makes hand-carried ultrasound devices.
• SynCardia Systems (Tucson, Arizona), reports the availability for clinical investigation of a portable driver, the Companion, that is designed to allow stable U.S. patients to recover at home while they wait for their donor heart for transplant. For OR and ICU applications, the Companion is designed to be docked into a hospital cart that features a 15” monitor intended to be viewed from across a room. For stable patients to be discharged, the Companion is designed to be “re-docked” into a smaller caddy that features large wheels and an adjustable handle intended to facilitate patient mobility. SynCardia makes the only FDA- and CE Mark-approved temporary total artificial heart.
• Toshiba America Medical Systems (Tustin, California) reported the completion of enrollment for 400 patients in its CorE 64 (Coronary Evaluation on 64) study taking place in seven countries, the largest trial ever initiated evaluating the use of 64-slice CT technology, the company said. The trial’s enrollment completion signifies that the study of all patient participants has finished, resulting in the most statistically reliable data available to date. The trial investigates the use of multi-slice CT as the primary diagnostic tool for detecting cardiovascular diseases and disorders, as compared to cardiac catheterization, a costly, invasive technique. Toshiba America Medical Systems makes diagnostic imaging systems, and coordinates clinical diagnostic imaging research for all modalities in the U.S.
• WaveLight (Sterling, Virginia) reported that the FDA clearance of wavefront-guided and mixed-astigmatism indications for the Allegretto Wave Eye-Q system. The Eye-Q wavefront-guided LASIK procedure was approved for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent of myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane. The procedure may be performed on patients who are 18 years of age or older with documentation of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. The procedure may also be performed with a custom offset of -3.00 to +1.00 D for sphere and -3.00 to 0.00 D for cylinder. The Eye-Q was approved for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane in patients who are 21 years of age or older with documentation of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. WaveLight makes products for ophthalmology and specializes in vision optics.
• Wright Medical Group (Arlington, Tennessee) reported the commercial launch of the Charlotte 7mm multi-use compression (MUC) screw system for foot and ankle surgery. The “head” on a traditional headed screw sits prominently above the surface of the bone which can irritate the soft tissues in the heel or ankle when the patient walks, potentially requiring secondary surgery to remove the screw. The 7mm MUC screw system was engineered to address the potential shortcomings of traditional screws by creating a head that resides completely within the bone, rather than above the bone surface. Wright is an orthopedic device company.