BB&Ts

For many people, anxiety builds at just the thought of a dental appointment. One of the worst aspects of dental work is simply getting painful anesthetic injections. In response, Bresslergroup (Philadelphia) has produced DentalVibe, a new device that takes the fear and pain out of dental injections by tricking the brain with a vibrating diversion.

The premise behind the DentalVibe is that most dentists already grab the cheek and shake as they inject.

“This idea came to us from a dentist in Florida who came up with the general idea of masking the pain from dental injections by introducing a tool that vibrates the gum during injection,“ David Schiff, Bresslergroup director of engineering, said.

Research shows that fear of a painful anesthetic injection keeps half of the patient population away from the dentist. Steven Goldberg, DDS, latched on to the idea that shaking the tissue briefly masks the pain and refined it.

“He started out with a vibrating flosser and held it to a patient's cheek,“ Schiff said. “He then came to us to develop it into a product. We did the research to determine, ergonomically, how it might be used and how it might be handled along with other dental instruments.“

Bresslergroup started with research using a laser interferometer, a device that uses the interference of waves, to determine the optimal vibration frequency and amplitude.

“We discovered that a continuous vibration masked the pain, but after a few seconds, your brain gets used to the signal and the pain signal of injection starts to come through again,“ Schiff said. “By introducing an intermittent pulse – a vibration and then it shuts off for a fraction of a second – it kept sending the vibrating signal to the brain anew.“

Now called the DentalVibe Gate Control Theory of pain management, it creates a diversion for the brain. The DentalVibe, a hand-held tool, also retracts the lips and illuminates the injection area with an LED light. These additional features help to avoid accidental needle sticks and enhance operator visibility, according to the company.

“A dentist only has so many hands,“ Schiff said. “They typically want to retract the cheek with a dental mirror and use the other hand to do the injection. DentalVibe frees up their hand.“

It contains a microprocessor which controls the VibraPulse technology. Those pulses travel along the A-beta nerve fibers and then are transmitted quickly to the brain. Pain sensations travel along the slower C fibers. So in the race to the finish, the brain feels the vibration, not the pain of injection.

The company plans no formal studies since FDA isn't required, and will rely on patient testimonials to boost sales.

DentalVibe, which costs $795 plus single-use, disposable tips, was launched at the Chicago Midwinter Dental Meeting last month.

“The big issue with dentists is how to recoup the cost of DentalVibe,“ Bresslergroup's Director of Marketing, Michael Flanagan, said. “The dentist has to market this to patients, pointing out that it's a differentiator to pull people into his practice. Once the patients experience it, we would think they would be happy with it and come back.“

Elsewhere in the product pipeline:

• Affymetrix (Santa Clara, California) reported the launch of the GeneAtlas System, a personal solution for processing Affymetrix arrays and characterizing changes in gene expression in a variety of research applications. The system includes all required instrumentation, training materials, and data analysis programs that provide biologically relevant results. The system uses a new array strip format that enables researchers to interrogate four distinct samples simultaneously. Array strips are available in options that provide comprehensive coverage of the transcribed human, mouse, or rat genomes for expression profiling. The array strip is also available for custom array designs through the MyGeneChip custom array program.

• Ascension Orthopedics (Austin) has launched the PyroTitan Humeral Resurfacing Arthroplasty System. Ascension claims the PyroTitan is designed to meet the unique soft tissue biocompatibility requirements of the shoulder joint, and is the first commercially-available human shoulder arthroplasty prosthesis made of PyroCarbon. The system is intended to address glenohumeral joint disease due to non-inflammatory, inflammatory and post traumatic arthritis by replacing the damaged humeral head bearing surface and restoring patient anatomy while preserving bone. This system provides size-specific, color-coded, cannulated instrumentation for ease of use and reproducibility.

• Axis Surgical Technologies (Mountain View, California) received FDA clearance for the C-MOR visualization device for use in diagnostic and operative arthroscopic and endoscopic procedures. The self-contained, portable, direct-imaging tool provides illumination and visualization of an interior cavity through either a natural or surgical opening. The C-MOR displays real-time endoscopic images directly using an on-board LCD display, providing better use of the surgeon's natural field of view and range of motion, as well as providing immediate diagnosis for structural issues, such as ligament tears. The intuitive design equips office-based physicians with modern imaging capabilities designed to enhance continuity of care, as well as potentially enabling the treating physician to immediately diagnose injuries without having to wait for MRI results, the company says.

• biospace med (Cambridge, Massachusetts) has received FDA approval for the sterEOS 2-D/3-Dworkstation for pediatric use in spine applications.The sterEOS workstation enables 3-D bone-envelope-modeling in a weight-bearing position and provides over 100 clinical parameters to the orthopedic surgeon for pre- and post-operative surgical planning. biospace med says the EOS can capture head-to-toe images of children and adults in a standing, weight-bearing position with a dramatic reduction in radiation dosage—up to 10 times less than a conventional x-ray and up to 1000 times less than a CT scan. And, the full-length, weight-bearing imaging capabilities of EOS provide physicians with a global vision of balance and posture.

• bioTheranostics (San Diego) reported the launch of an expanded tumor-type database for its flagship product, CancerTYPE ID, and the launch of KRAS mutational testing. CancerTYPE ID predicts cancer origin in patients whose primary cancer was initially “unknown or uncertain“ using conventional diagnostics. Knowing the site where the cancer originated impacts physicians' therapeutic decisions, and the results of the CancerTYPE ID assay can help physicians select optimal therapies earlier in the diagnostic process. In tissue samples for which CancerTYPE ID returns a positive result for colorectal cancer, the availability of KRAS, a companion diagnostic test for anti-EGFR therapy, enables medical professionals to obtain additional valuable information and make individualized treatment decisions. KRAS will also be offered as a stand-alone test.

• CaridianBCT (Lakewood, Colorado) has received FDA approval for the Trima Accel Automated Blood Collection System Version 6.0. The latest version of the Trima Accel system includes the Auto Red Blood Cell (RBC) procedure, allowing for the collection of a ready-to-transfuse leukoreduced red blood cell product from donors and eliminating the requirement for post-procedure leukoreduction and addition of storage solution. “The Trima Accel V6.0 Auto RBC procedure brings a host of improvements and additional ease-of-use to blood centers and helps them meet the changing blood supply needs of hospitals,“ said Bob Cole, senior VP of CaridianBCT's automated collections business area. “By increasing efficiencies through streamlining operations and reducing the opportunities for error, the Auto RBC procedure will benefit blood centers.“

• Corgenix Medical (Denver) has introduced its new automation friendly anti-phospholipid assay format. Automated microplate ELISA processing from Corgenix is available for a range of anti-phospholipid antibody screening tests, including anti-Cardiolipin (aCL) antibodies, anti-Phosphatidylserine (aPS) antibodies and anti-Beta2 Glycoprotein I IgG antibodies. Corgenix makes specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders.

• Genomic Health (Redwood City, California) said that its research scientists have developed a clinically useful method for whole genome expression analysis using standard tumor specimens that are routinely collected in clinical practice. Genomic Health said it is now able to access the entire transcriptome, or all of the RNA that is made by cells, in order to quantify the gene expression profile in a single assay using sequencing technology developed by Illumina.

• Henry Schein (Melville, New York) reported the launch of Henry Schein ConnectHealth, an initiative that is a partnership of Henry Schein and electronic health record, medical device, and computer services companies, which have come together to help physicians meet the demands of creating and maintaining a coordinated, efficient digital office. The company claims the ConnectHealth will seamlessly connect electronic health records with medical devices and coordinate all information technology aspects of the physician's office.

• Hill-Rom (Batesville, Indiana) reported the extension of its smart room technology to provide a choice of solutions that connect the smart bed and other medical devices to the Electronic Medical Record (EMR) on both a wired and a wireless platform. The Hill-Rom connectivity platform creates options for hospital staffs to choose the solution that is optimal for their existing hospital IT infrastructure. In turn, this technology can improve the clinical workflow for nurses and reduce the clinical documentation burden for front-line caregivers by automating medical device data transmission to the EMR.

• N.M.B. Medical Applications (Thornton-Cleveleys, UK) reported FDA approval of the Quantum Humeral Composite Nailing System. The system is an intramedullary interlocking nail made of Endolign (from Invibio Biomaterial Solutions). Endolign, an inherently pure and inert composite of continuous carbon fibers in a Peek-Optimapolymer matrix, enables patient/surgeon benefits that can advance the treatment of long bone fractures. N.M.B. says the Quantum Composite Nail design combines with Enodlign's unique material characteristics and performance capabilities to challenge the limitations of Titanium and Stainless Steel.

• OrthoDynamix (Jacksonville, Florida) said it has received FDA clearance for its new device, ArthroSteer 3.5 mm Ablator, a mono polar electrosurgical device, for general surgical use, including the orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulating soft tissue in, but not limited to the knee, shoulder, and primarily the hip. ArthroSteer's technology improves triangulation and or orientation of its instruments in tight joint capsules enabling the surgeon greater access to damaged tissue.

• Pari Respiratory Equipment (Midlothian, Virginia) launched their newest aerosol delivery system, the Vios. Paired with Pari's gold standard reusable nebulizers, Vios delivers fast treatments, small particle size, and high respirable drug dose to the lungs, the company said. PAri says the Vios includes either two Pari LC PLUS or two Pari LC Sprint nebulizers, allowing physicians to make the choice best suited to the situation.

• Pioneer Surgical Technology (Marquette, Michigan) reported the launch of its Contact Anterior Lumbar Plate (ALP). This plate provides a one-step locking mechanism along with back-out protection and controlled screw toggle. The plate was designed for optimum synergy with the company's Contact PEEK Anterior Interbody Spacer.

• PositiveID (Delray Beach, Florida) said that its new generation Health Link personal health record (PHR) is designed to be the first PHR to provide real-time blood sugar readings for diabetics, and their caregivers or physicians. The company intends to integrate its Health Link PHR with its iGlucose system, which uses wireless SMS messaging to automatically communicate a diabetic's glucose levels in real-time.

• Predictive Biosciences (Lexington, Massachusetts) has introduced its Multi-Analyte Diagnostic Readout (MADR) approach to the development of a non-invasive, urinary biomarker based assay for the detection of bladder cancer during the 2010 Genitourinary Cancers Symposium. The MADR research, which combines protein and DNA biomarkers to identify with high certainty a group of bladder cancer patients who are disease free and could be excluded from undergoing invasive procedures, was conducted under collaboration agreements with Lahey Clinic Medical Center and Mayo Clinic. The MADR approach is being used by Predictive in the development of its CertNDx line of cancer assays, and is an extension of Predictive's Clinical Intervention Determining Diagnostic (CIDD) approach. CIDD was developed by Predictive to identify biomarker cutoffs that maximize negative predictive value in order to identify with very high certainty those who require no further intervention.

• SensAble Technologies (Woburn, Massachusetts) said that it will be offering a second, fully integrated scanner option for the SensAble Dental Lab System, as well as SensAble's new OpenScan software interface. SensAble is also incorporating its OpenScan interface into the latest release of its software, which will allow technicians using the SensAble Dental Lab System to import STL files from other open scanners that their labs may already have. The SensAble Dental Lab System is an integrated digital solution to scan, design and fabricate common dental restorations.

• Stryker Interventional Spine (Kalamazoo, Michigan) has launched the VertaPlex HV – a high viscosity bone cement for use in treating vertebral compression fractures. Vertebroplasty and vertebral augmentation (also known as balloon kyphoplasty) are minimally invasive procedures widely used to treat the intense pain caused by VCFs. They involve injecting bone cement into the vertebral body to create an internal cast that stabilizes the fracture, thereby reducing pain. Stryker claims the VertaPlex HV cement achieves a thick viscosity as soon as it's mixed so there's no waiting time. It maintains this viscous state for an average of 18 minutes or longer, helping to satisfying the desire for immediate and longer working time. VertaPlex HV's thick viscosity helps contribute to a controlled fill that interdigitates with the trabecular bone.

• Toshiba America Medical Systems (Tustin, California) has unveiled new cardiac software enhancements available now for the Aquilion ONE and Aquilion Premium CT systems.

Toshiba says the software upgrades will improve cardiac CT imaging in the following ways:

– New ONE Beat Prospective Reconstruction shortens the interval window and reduces radiation exposure time. This enhancement alone reduces radiation dose by 21% over the previous software, as the more efficient imaging lowers the radiation exposure to the patient;

– Real Time Beat Control calculates the running real time average of the heart rate to precisely predict the next heart beat for a more accurately timed scan. Important for patients with arrhythmia or unstable heart rates, Real Time Beat Control ensures better accuracy and improves image quality while reducing repetitive exams.

• In an effort to put critical patient information in the hands of physicians at the bedside, University of Pittsburgh Medical Center (UPMC) said that it has developed its first electronic health record (EHR) application for BlackBerry smartphones. The pilot project gives physicians access to such information as a patient's allergies, current medications and recently completed lab tests. UPMC's application for BlackBerry smartphones is enabled by the health system's interoperability platform, created by technology partner dbMotion (Pittsburgh). The dbMotion Solution allows UPMC to present clinicians with a single, comprehensive view of key patient data, including allergies, medications, lab results, problems and physician notes, without replacing existing information systems. It also provides “semantic interoperability“ to clinicians, which allows data to be transferred and organized in meaningful ways, according to UMPC.