Monday, March 15, 2010
Medtronic's DBS Therapy for Epilepsy May Yet Get FDA Approval
An FDA advisory panel has voted 7 to 5 in favor of approval of Medtronic's deep brain stimulation (DBS) device, probably the Soletra, as a treatment option for medically refractory epilepsy in certain patients. The device, already approved for Parkinson's, was only days earlier reported to have failed an important study goal. Now it is seeing new life, and potential approval, due to a kink in the latest study.
Jennifer Corbett Dooren at the Wall Street Journal explains:
A study of the device was conducted in 110 patients, but it failed to meet a study goal that looked at a reduction in the seizure rate over a three-month period.However, the FDA said that when looking at just the third month of treatment, patients being treated with the deep-brain-stimulation device had a greater reduction in seizures compared with patients whose device was not activated.
The missed study goal was influenced by one patient who developed a different type of seizure after the device was turned on, both the FDA and Medtronic said. When the device's power was lowered, the seizures stopped.
Medtronic asked the FDA and the panel to consider the data without the one patient, which would result in the study meeting the three-month goal, or to consider the last month of the three-month period. But the panel was divided on whether the patient should be removed from the analysis of the study.
Wall Street Journal from March 10: Medtronic Brain Stimulator Missed Study Goal
Wall Street Journal from March 12: FDA Panel Backs Device For Epilepsy
Medtronic press release: FDA Panel Recommends Approval with Conditions of Medtronic Deep Brain Stimulation Therapy for Patients with Refractory Epilepsy ...
Flashback: Medtronic's Deep Brain Stimulation Devices Approved for Parkinson's and Essential Tremor
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Thursday, March 11, 2010
VERTEX SELECT Occipitocervical Spinal Reconstruction System from Medtronic
Medtronic is making available in the US its VERTEX SELECT Reconstruction System, a package for performing cervical spinal stabilization procedures via the posterior approach.
From the press release:
When paired with the VERTEX SELECT® Occipitocervical Module this system comprises a comprehensive posterior cervical-upper thoracic spinal system that offers adjustability through multiple plate designs, rods, screws, and hooks that gives surgeons more options during surgery, enabling them to tailor the procedure to each patient’s needs.The VERTEX SELECT® System can be used to treat patients with degenerative disc disease, spinal stenosis, fracture, dislocation, failed previous fusions, and or tumors.
Press release: Medtronic Introduces the Vertex Select® Reconstruction System ...
Flashbacks: Occipitocervical Fusion Module from Medtronic...
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Monday, March 8, 2010
sterEOS 2D|3D Workstation Images Spines With Significant Radiation Reduction
Biospace Med, maker of X-ray imaging systems out of Paris, France, just received FDA approval to use the firm's sterEOS 2D|3D workstation on pediatric patients to image the spine. The company claims that the system provides imagery competitive to that of CT scanners, but with only .1% of the radiation dose. Patients remain standing while the system simultaneously takes an X-ray from the front and laterally, after which a computer reconstructs the two frames into a three dimensional representation of the spine. This allows for quick imaging of patients in a weight bearing position while significantly reducing their radiation exposure compared with CT.
From the press announcement:
“FDA clearance for sterEOS pediatric use in spine will have a significant impact on demand for EOS as it will allow for the first time to visualize in 3D the spine deformations in the standing, weigh bearing position and retrieve fundamental clinical parameters for surgical planning. This is all done at a drastically reduced radiation exposure, and enables to repeat exams for a better follow up from childhood to adulthood,” said Peter Newton, M.D., Rady Children’s Hospital, San Diego, Ca. “Reduction of radiation exposure is especially important for children and adolescents who have scoliosis or other types of musculoskeletal disorders that are being followed on a frequent basis and therefore need to have regular x-rays over a long period of time to watch the progression of their condition and treatment. A technology that can reduce radiation exposure up to 10 times compared to a conventional x-ray and up to 100 or more times compared to a CT scan is a major breakthrough for orthopedic imaging, especially for the pediatric population.”
Press release: FDA clears Biospace med's sterEOS 2D|3D workstation for pediatric use in spine...
(hat tip: MassDevice)
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Friday, March 5, 2010
marLED Surgical Lights from KLS Martin
By perusing through the latest stuff coming out of Germany, we found a little press release from Gebrüder Martin GmbH & Co.KG, also known as KLS Martin Group, that profiled the company's new generation of operating lights, named marLED.
This operating room fixture runs on what the company calls "Second-Generation LEDs" and is designed to minimize formation of shadows and to deliver a cold, bright light. Furthermore, the marLED can be equipped with KLS Martin's surgiCam SD and HD camera systems, for an intraop procedure recording. The camera can be seen in the picture below.
From marLED product page:
In this brand-new product line, high-performance LEDs are used as a basis for effective problem solution even where surgical field illumination is difficult. By using a new overall approach in terms of design as well as lighting technology, it was possible to overcome the limits of existing solutions and set new standards regarding shadow prevention and color fidelity. The radically new optical and housing concept also makes a lasting contribution towards facilitating the surgeon's work. The innovative, modern design with its symbiosis of ergonomics and technology gives the operating room a pleasing, state-of-the-art atmosphere.Maximum adaptation of the light field Space-saving design creates room for movement Compatibility with laminar flow systems Ergonomic and perfectly easy operation with sensoTouch and sensoGrip Cool light and excellent shadow compensation Variable color temperature
Product pages: marLED; surgiCam
Press release: The marLED Lights from KLS Martin ...
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Friday, February 12, 2010
Neuro PBV IR from Siemens Monitors Intracranial Parenchymal Blood Flows
Siemens has just announced the release of the Neuro PBV IR computed tomography suite that provides a live look of inracranial blood flows for neuroradiologists performing clot lyses, stent placements, ablations, etc.
With syngo Neuro PBV IR (Parenchymal Blood Volume, Interventional Suite), Siemens Healthcare has developed a new application for interventional radiology that allows you to review parenchymal blood flow during minimally invasive interventions in the brain for the first time. This feature assists the neuroradiologist in the treatment of stroke patients by displaying the condition of the cerebral tissue directly in the angio suite.This not only results in clinical advantages for stroke treatment, but is equally helpful for tumor biopsy and treatment, tissue embolization, and vasospasm therapy (spasms of blood vessels).
Another benefit of the new Siemens software is that it is capable of providing blood volume data for the whole brain, unlike traditional CT acquisition, and allows the clinician to review the information from any orientation, axial, coronal, sagittal etc. Syngo Neuro PBV IR uses cone-beam CT technology (syngo DynaCT) to acquire the information required for such advanced tissue visualization.All that is required to generate the PBV information is two C-arm rotations around the patient and a steady state contrast injection. The sophisticated processing algorithms of the system use the resulting data to generate a neurological PBV map. The information is available at tableside, in less than 40 seconds, without the need for any further user interaction.
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Wednesday, February 3, 2010
Swift-Lock to Make Lead Anchoring Fast and Easy
At the ongoing American Academy of Pain Medicine annual meeting in San Antonio, St. Jude Medical unveiled the new Swift-Lock anchor for neurostimulation leads. The device was just approved by the FDA as an easier option of attaching anchors to leads of implantable neurostimulators.
From the announcement:
Designed to reduce anchoring time and enhance procedural efficiency, the Swift-Lock anchor eliminates the need for sutures or medical adhesive typically required to secure the anchor to the lead. Featuring an easy-to-use mechanical lock, physicians secure the anchor with a simple 90-degree twist. This design minimizes the complexity and variability associated with anchoring leads.The Swift-Lock anchor features include:
Intuitive locking mechanism that provides tactile and visual confirmation that the lead is locked
Strong fixation to the lead to help mitigate the risk of migration
Highly radiopaque material to provide easy fluoroscopic visualization
Simple twist lock mechanism allows for easy repositioning of the lead if needed
Press release: St. Jude Medical Unveils Latest Product at American Academy of Pain Medicine Annual Meeting
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Tuesday, January 19, 2010
IMRIS Combination MRI Fluoroscopy Systems for Intraprocedural Multimodal Imaging
IMRIS out of Winnipeg, Canada recently received FDA approval to market the firm's neurovascular and cardiovascular combination MRI/X-ray angiography systems. The IMRISnv and IMRIScardio systems feature MRI scanners that ride on rails attached to the ceiling and a complete fluoroscopy package that can be swung in and out of the surgical field. This combination allows clinicians to quickly evaluate the problem, perform a procedure, and then check back with the MRI to see how it went, all without moving the patient.
IMRISNV features a wide bore 3T MRI scanner and a bi-plane angiography system completely integrated into a single suite that permits the patient to transition quickly and seamlessly between MR imaging and intervention without transporting the patient between modalities. Using IMRISNV, MR images can be taken before and during procedures to assess tissue health, and can also be used in conjunction with the fluoroscopic images during the interventional procedure. On completion of the procedure, new images can be taken to evaluate the intervention.IMRIScardio provides physicians with enhanced images for visualizing the cardiovascular system before, during and after an intervention. The IMRIScardio suite includes a wide bore 1.5T MRI scanner and a single-plane or biplane angiography system providing the ability to alternate between imaging modalities and immediately assess treatment.
Link: IMRIS...
Press release: IMRIS RECEIVES FDA CLEARANCE FOR IMRISNV AND IMRIScardio... (.pdf)
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Thursday, January 7, 2010
Sovereign Spinal Fusion From Medtronic Unveiled
Medtronic has announced a release of an intervertebral body fusion device, a system called SOVEREIGN™, that can provide spine stabilization in patients that want to avoid bone grafts, and the traditional metal plates.
The SOVEREIGN Spinal System incorporates a lens-shaped device with three holes for the placement of titanium screws, which protrude through the device and stabilize the adjacent vertebral bodies while preventing expulsion of the implant. The system also incorporates a cover plate that is designed to resist screw backout and that must be used in combination with the screws. Made of polyetheretherketone (PEEK), the SOVEREIGN device is radiolucent on x-rays, which allows the surgeon to view the spinal fusion during a follow-up visit.The SOVEREIGN Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous vertebral levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The implant may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN intervertebral body fusion device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN interbody device is intended to be used with the three titanium alloy screws and the accompanying cover plate. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation which has been cleared by the U.S. Food and Drug Administration for use in the lumbar spine must be used to augment stability. The accompanying cover plate MUST be used anytime the device is used with any number of screws.
Press release: Medtronic Introduces the Sovereign™ Spinal System for Lumbar Surgery...
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Friday, December 18, 2009
eXimia NBS System For Non-Invasive Brain Mapping Gets US OK
The FDA has given approval to Nexstim (Helsinki, Finland) to market the firm's Navigated Brain Stimulation System for the "assessment of the primary motor cortex for pre-procedural planning". The system uses traditional MRI data to guide the TMS (Transcranial Brain Stimulation) device to map the motor cortex so as to avoid performing direct cortical stimulation during brain surgery.
Integrated, TMS-compatible 6-channel EMG Designed for clinical use: Fast setup, ready to use in few minutes - complete documentation with online and offline reporting Accurate targeting of stimulation: Online calculation and display of location and strength of the stimulating intracranial electric field Guided and controlled repetition of any previous excitatory or inhibitory stimulus within 2 mm accuracy and 2 degrees tilting and orientation Repeatable sessions: Automatic recording of stimulation and response data, documentation of session workflow for later replication and analysis Easy to use: Software help tools available on-screen:
- Grid for systematic brain mapping
- Targeting tool for optimal coil placement
- Aiming tool for precise repetition of given stimuli
- Automated stimulation (location controlled)
- Display of somatotopic maps in color
Optimal performance with Nexstim eXimia TMS
Also programmable for compatibility with Medtronic/Magventure or Magstim TMS stimulators and coils
Press release: FDA clears Nexstim's Navigated Brain Stimulation for non-invasive cortical mapping prior to neurosurgery...
Product page: eXimia NBS System with integrated EMG...
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Esteem Totally Implantable Hearing Device Under Consideration for Approval in US
Today at the Ear, Nose, and Throat Advisory Committee of the FDA a meeting is under way to consider whether to recommend approval of Envoy Medical's (St. Paul, Minn) fully implantable hearing aid. The Esteem device uses a piezoelectric sensor to monitor the eardrum and convert the signal into digital for processing. The processed information is then converted back into physical vibrations and applied to the stapes capitulum. MedPage Today is reporting that in a recent clinical trial the device improved the hearing of a good number of subjects, but almost half experienced some sort of adverse effects such as taste disturbance and facial palsy.
The Esteem™ Totally Implantable Hearing Device (TIMED) is a totally implantable hearing system that is implanted under the skin behind the ear and in the middle ear space. The Esteem™'s purpose is to help improve hearing in adult patients who have mild to severe sensorineural hearing loss, and who have at least 60% or better discrimination of words (WRS). The goal is to provide comfortable, natural sounding, high fidelity sound to participants with sensorineural hearing loss by direct driving of inner ear fluid.The Esteem™ device consists of: (1) a Sensor-PZT transducer that serves as a microphone, (2) an implantable Esteem™ Sound Processor containing a non-rechargeable battery, (3) connecting IS1-like leads that detach from the Sound Processor, and (4) a Driver-PZT transducer that vibrates the stapes. There is no external hardware, and the ear canal is not occluded. Control and programming of the Esteem™ are achieved through transcutaneous telemetry. Black arrows indicate the pathway that sensed sound energy travels through the Esteem™ system. The second (incus) and third (stapes) hearing bones are separated to prevent feedback vibrations.
More from MedPage Today...
Product page: Esteem-Hearing Implant...
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Monday, December 14, 2009
Promising Results Released in Controlling Epilepsy via Deep Brain Stimulation
Last week at the American Epilepsy Society Meeting in Boston, Medtronic and NeuroPace released results of clinical trials studying the benefits of the firms' competing Deep Brain Stimulation (DBS) systems to control symptoms in patients suffering from severe epilepsy. The findings seem to foreshadow the future in which the technology might become a standard treatment option for patients who continue to develop seizures despite adequate medication regiments, and in some cases, vagus nerve stimulation or even ablative surgery.
From Medtronic's announcement:
The results of the study show improvement over time with median (mid-point) reduction in seizure frequency of 41 percent at one year, 56 percent at two years, and 68 percent at three years of DBS therapy, in conjunction with antiepileptic medications, compared to baseline. Of the original 110 patients who received DBS implants in the trial, 91 remain active in the study, including some who have received DBS therapy for more than five years. At the time of this data analysis, 102 patients had completed two years and 57 had completed three years of therapy. In addition, 14 patients (13 percent) experienced seizure free intervals ranging from six months to more than four years.The study, known as SANTE® (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy), is a prospective, randomized, double-blind pivotal study to evaluate the use of DBS therapy for patients with medically refractory epilepsy with partial-onset seizures, a form of epilepsy that does not respond well to antiepileptic drugs.
The types of adverse events reported in the study were consistent with known adverse events associated with epilepsy and implanted DBS systems. There were no serious unanticipated device-related adverse events. At the conclusion of the unblinded phase of the study (first 13 months), 4.2 percent of adverse events (a total of 34 events) were serious and device-related. That rate declined over time. Of the 34 events, the most frequent serious device-related events were lead(s) not within the target (nine events) and implant site infection (eight events). Depression and memory impairment were reported more frequently in active stimulation patients compared to no stimulation (controls) although objective neuropsychological assessment did not show any statistical differences between active or no stimulation (control) groups.
The SANTE study involves stimulating the left and right anterior nucleus of the thalamus – the brain’s central message and relay station – with Medtronic DBS Therapy for Epilepsy in conjunction with epilepsy medications. Patients in the study have had epilepsy for an average of 22 years and 54 percent of the 110 implanted patients had previously undergone resective surgery and/or vagal nerve stimulation therapy. Benefit was seen in patients with prior history of vagal nerve stimulation or previous epilepsy surgery as well as patients without such history.
From a statement by NeuroPace:
The trial demonstrated a statistically significant reduction in seizure frequency in the treatment group (responsive stimulation active) as compared to the sham stimulation group (responsive stimulation inactive). During the last two months of the three month blinded evaluation period of the study, people in the treatment group experienced a mean percentage reduction of 29 percent in their disabling seizures compared to 14 percent reduction for those in the sham stimulation group. In the long term, open label period of the trial, at least 12 weeks of data were available for 171 study participants; 47 percent of these subjects experienced a 50 percent or greater reduction in their seizure frequency based on their most recent 12 weeks of data, as compared to their baseline.The trial also demonstrated a serious adverse event rate less than comparative surgical procedures. There were no serious unanticipated device related adverse events reported in the trial. There was no difference between the treatment and sham stimulation groups when comparing the rate of adverse events, including depression, memory impairment and anxiety.
Press releases: Pivotal Study of Medtronic Deep Brain Stimulation Therapy Shows Long-Term Reduction in Seizure Rate in Patients with Severe Epilepsy; Pivotal Trial Data Demonstrate NeuroPace RNS System Reduced Seizures in People with Epilepsy...
Product pages: Medtronic DBS...; NeuroPace RNS System...
Flashbacks: Medtronic to Seek FDA Approval of Brain Stimulation Device for Epilepsy; Neuropace Implantable Epilepsy Device Showing Positive Signs in Initial Clinical Study
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Will High Def 3D Binocular Disparity Monitor Make a Clinical Jump?
LG of Seoul, South Korea has released a 23 inch LCD monitor that can display 3D video and graphics at full HD resolution (we're assuming this means 1080p). The system comes with shutter glasses that synchronize to how the screen flashes between views for the left and right eye, an effect called binocular disparity. Now it's looking more and more likely that 3D technology will soon be a common modality to view volumetric, live images in radiology rooms and in the ORs.
The panel adopts the company’s proprietary technologies such as “high performance 3D exclusive controller” capable of processing more than twice as much image data as other HD 3D LCDs and “copper bus line” to improve on the resolution and picture quality. In addition, the panel is able to reproduce both 2D and 3D images, meaning that users can switch back and forth from 2D and 3D modes.Although full HD 3D images have been developed for contents such as video games, movies and animations, 3D display products with full HD resolution were unavailable in the market. The commercial launch of LG Display’s full HD 3D LCD panel is expected to help to boost development of high resolution 3D contents while allowing users to view true-to-life 3D images.
Press release: LG Display Rolls Out 3D LCDs with Full HD Resolution
(hat tip: Vizworld)
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Friday, December 4, 2009
Penta Spinal Stimulator Lead Gets Approval in US
St. Jude Medical has received FDA regulatory clearance for the firm's new five-column neurostimulation lead. The Penta™, being unveiled at North American Neuromodulation Society meeting, sports the market's smallest electrodes arranged in five columns.
This innovative surgical lead provides the broadest lateral electrode span of any neurostimulation lead on the market -- yet the paddle configuration is only 10.9 mm wide. The Penta lead's unique design is made possible by a proprietary micro-texturing process which enables greater amounts of current to be delivered via the small electrodes. The result is a lead that can more specifically focus current over a greater lateral area of the spinal cord, which may provide better coverage for managing hard to control chronic pain.
Press release: St. Jude Medical Receives FDA Approval for Industry-First Five-Column Neurostimulation Lead to Manage Chronic Pain...
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Thursday, December 3, 2009
SJM Releases New Neurostimulator Programming Software
At the ongoing North American Neuromodulation Society annual meeting in Las Vegas, St. Jude Medical is unveiling new software to help program company's spinal cord stimulators. The new MultiSteering Technology for the Rapid Programmer platform aims to make customizing neurostimulators faster and more comprehensive.
Features from the press release:
Allows more than 10 times the number of electrode configurations to be evaluated in the same amount of time as conventional programming Efficiently captures multiple painful areas by enabling the clinician to evaluate stimulation patterns in real time Provides control of multiple stimulation fields for optimal pain coverage
Press release: New Neurostimulation Patient Programming Software Enables More Thorough and Efficient Capture of Complex Pain Patterns...
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Friday, November 20, 2009
Let Draeger Polaris Be Your Guiding Light
We are continuing to profile the latest gadgets that are being showcased at the Medica 2009 in Düsseldorf. This beautiful line of cold OR light systems, appropriately dubbed Polaris, comes from Drägerwerk AG & Co., a company better known to everyone as Dräger.
Details from the press release:
Compared with conventional light sources, the smaller LEDs of the Polaris system are considerably more energy-efficient than conventional light sources. An LED light source has a life span of about 30,000 hours (corresponding to about seven to ten years of service life in the operating room), while the life span of a conventional light source is about 1,000 hours (corresponding to about four months of service life in the operating room). The slight amount of lost heat from the LEDs is dispensed through the top of the housing.The different Polaris models are distinguished by their illuminating power. They can be used as an individual OR light or as a satellite in multiple-light systems, and can also be equipped with an integrated camera.
This new product design received the red dot design award 2008 which, according to the Design Zentrum Nordrhein Westfalen, is based on criteria such as innovation, functionality, quality and ergonomics.
The 108 light-emitting diodes of the Polaris (700 model) distribute light with a color temperature of 4,600 Kelvin. "Cold light" (without long-wave infrared content) is generated by means of a phosphor layer on the semiconductor and focused via an optical system. The LEDs are installed in the reflectors in pairs.
The individual light paths form a light cylinder which has an illumination depth of about 1,100 millimeters and a variable diameter of 220 to 290 millimeters. This ensures that the light of each LED can be focused on the OR field and that several surgeons can work simultaneously on the OR field without noticeably reducing the brightness.
Press release: Precision lighting with the new Dräger Polaris...
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Monday, November 16, 2009
DuraSeal Spine Sealant Gets FDA Green Light
Covidien has made an announcement that it obtained FDA approval for the DuraSeal™ Spine Sealant, a synthetic hydrogel indicated for closure of dural tears that occur during spine surgeries. According to MassDevice, it took seven years and a $245 million merger of Covidien with Confluent Surgical to deliver DuraSeal to the market.
From the press release:
In a clinical study of more than 150 patients, DuraSeal spine sealant was shown to be superior at achieving an intra-operative watertight seal, compared with the control group, which consisted of conventional methods of dural closure such as sutures or fibrin sealants. DuraSeal spine sealant achieved an intra-operative watertight seal 100% of the time, compared with 64% of the time by the control group. The safety results between the two groups were similar, given the patients' medical conditions and the nature of the complex spinal procedures performed.The new sealant is a 100% synthetic hydrogel that provides excellent tissue adherence, is absorbed by the body and is easy to apply. Stored at room temperature, DuraSeal spine sealant takes only two minutes to prepare and three seconds to set, which enables surgeons to achieve an intra-operative dural seal quickly.
Press release: Covidien Introduces First FDA-Approved Spine Sealant ...
Product page: DuraSeal ...
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Tuesday, November 3, 2009
Simple iPhone App Measures Spine Angles on X-rays
Dr. Frederic P Jacquot, an orthopedic surgeon from France, developed an innovative iPhone application that could measure spine curvature angles "on the fly." Just like other spine clinicians, Dr. Jacquot was trained to measure the Cobb angle, kyphosis angle, and the sacral slope on spine radiographs. So instead of using a protractor, he realized that he could utilize the accelerometer inside the iPhone to do it.
All that one has to do in using the device is align the side of the iPhone to the standard tracings we use routinely, and the position sensor built in the iPhone will do the rest.The precision of the device itself is 1/10th of a degree, far more precise than the precision of the measure as determined in everyday practice and the literature.
Measures are logged for further use and may be sent by e-mail to the surgeon or staff for recording purposes, with the levels of the measured curve, type of curve and patient id or number. A calibration procedure was also implemented to accurately measure the angle with the horizontal plane as in the sacral slope.
Product page: CobbMeter ...
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Monday, October 26, 2009
TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems
Siemens has just announced that it has integrated the TruSystem 7500 OR table from TRUMPF (Puchheim, Germany) with its Artis zee and Artis zeego fluoroscopy scanners. The TruSystem 7500 adjusts to just about any position imaginable and is transparent to x-rays, and so can be used in almost any surgical or invasive radiological procedure. TruSystem 7500 OR table is illustrated above, and Artis zeego multi-axis interventional fluoroscope is shown in the picture below.
The Trumpf OR table has been designed especially for this integration and is equipped with a onepiece carbon tabletop, which can be replaced by a segmented universal tabletop. The table column enables the two tops to be exchanged easily. The carbon tabletop is transparent to X-rays and thus ensures that there will be no disruptive artifacts in the images. It is suitable for interventional procedures and minimally invasive surgery. The integration of the OR table with the Siemens angiography systems also make fast rotations and 3-D imaging possible with the surgical C-arm. The modular design of the segmented tabletop enables extremely flexible positioning of the patient, particularly important in orthopedics and neuro surgery. Complicated positions, such as the chest side position, can be achieved quickly with great precision as well as comfort for the patient and staff.
Along with the integrated Trumpf OR table, Siemens continues to offer its Artis tables for the entire Artis zee series, which are available in three designs: as a standard table, a table with Trendelenburg tilting and one with Trendelenburg and lateral tilting.
Press release: Siemens integrates Trumpf's OR table in its Artis zeego and Artis zee ceiling angiography systems...
Product pages: TruSystem 7500, Artis zee, Artis zeego
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Wednesday, October 21, 2009
ThumBlade Scalpel Safety System
Here's an interesting new take on improving the safety for scrub techs, nurses and surgeons. ThumBlade™ scalpel system from Precision Medical Devices Inc. (Marlboro, NJ) is a no contact, disposable safety sheath that covers blades, and allows activation of the scalpel with just one hand. So no more sharps and no more mosquito use to mount a blade.
Medgadget has obtained the following details about the device:
Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.
Product page: ThumBlade™ safety scalpel system...
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» Single Chip Stereo Endoscopy from Visionsense Coming to an OR Near You (October 20, 2009)
» Guardian II Hemostasis Valve Gets FDA Nod (October 13, 2009)
» Neuropace Implantable Epilepsy Device Showing Positive Signs in Initial Clinical Study (September 24, 2009)
» New Surgical Glue from Lifebond to Offer a Stronger, Tighter Seal (September 21, 2009)
» Medtronic Releases New Intraop Nerve Integrity Monitors (September 16, 2009)
» Brio DBS System Wins EU OK for Parkinson's; First Person Implanted with the Device (September 9, 2009)
» IsoFlow Catheter Helps Target Tumor During Chemo Infusion (August 25, 2009)
» FDA OK's PlasmaBlade for Tonsil and Adenoid Tissue Removal (August 4, 2009)
» Plato's Cave: New 3D Visualization System (July 27, 2009)
» New Cerebral Oximeter from Nonin Granted US OK (July 16, 2009)
» microECoG Electrodes Create New Possibilities to Study, Intervene in Brain Function (July 9, 2009)
» Brain Surgery With MR Guided High Intensity Focused Ultrasound (June 24, 2009)
» Braingate Neural Interface Developing Into Wireless Version (June 19, 2009)
» US Trial of Libra Deep Brain Stimulation System for Parkinson's Is Moving Along (June 9, 2009)
» BRYAN Cervical Disc Gets FDA Approval (June 2, 2009)
» Siemens Introduces Cappa C-Nav System for Navigating the Body Without Radiation (June 2, 2009)
» ViRob, a Cavities Crawler (May 28, 2009)
» Medtronic's Deep Brain Stimulation Devices Approved for Parkinson's and Essential Tremor (May 22, 2009)
» Libra DBS Showing More Promise in Study (May 21, 2009)
» MRI Assisted Laser Interstitial Thermal Therapy for Brain Tumor Treatment (May 15, 2009)
» Digital Subtraction Angiography on a Single Image (May 14, 2009)
» BrainLab's Digital Lightbox Getting an Upgrade (May 13, 2009)
» Lab-on-a-Tube for Multimodality Neuromonitoring Post Brain Injury (May 11, 2009)
» Occipitocervical Fusion Module from Medtronic (May 8, 2009)
» PEEK PREVAIL Cervical Interbody Device for Spinal Fusions (May 5, 2009)
» Magnus Operating Table from Maquet (May 4, 2009)
» Injectable Bone Graft for Minimally Invasive Spinal Surgery (April 30, 2009)
» TissuePatch Surgical Sealant Films (April 27, 2009)
» Barricaid Anular Reconstruction Device Gets EU OK (April 14, 2009)
» Libra DBS for Parkinson's Going Live in Europe (March 30, 2009)
» NeuroVasx Gets CE Mark for cPAX Aneurysm System (March 27, 2009)
» Cardinal's Endura Scrubs for the Modern Clinician (March 19, 2009)
» Apnex Hypoglossal Nerve Stimulation for OSA (March 16, 2009)
» Genesis IPG Now for Chronic Angina (March 11, 2009)
» MRI May Replace X-Rays for Catheterizations (March 3, 2009)
» Inspire II Implantable Nerve Stimulator for Obstructive Sleep Apnea (February 27, 2009)
» Medtronic's Reclaim Deep Brain Stim Approved for Some OCD Sufferers (February 20, 2009)
» Spinal Implants with CleanFUZE Silver Ion Antibacterial Technology (February 17, 2009)
» BeamPath NEURO CO2 Flexible Laser Helps Remove Brain Tumor from Fragile Spots (February 2, 2009)
» Wood Boring Wasps Inspire New Neurosurg Probe (January 27, 2009)
» European Union Approves Deep Brain Stimulation Systems for Parkinson's (January 26, 2009)
» Amimon's High Definition Wireless Video Goes Clinical (January 5, 2009)
» FDA Clears Polyzene-F based Embolic Microspheres (December 30, 2008)
» Image Guided Spine Navigation Systems Improve Spine Surgeon's Screw Placement (December 15, 2008)
» Medtronic to Seek FDA Approval of Brain Stimulation Device for Epilepsy (December 15, 2008)
» SmartBolts Help Avoid Tightening Errors (December 5, 2008)
» Somatom Definition Flash: All Around Dual Nature CT (November 24, 2008)
» Thinking Aloud...Interfacing With Speech (November 24, 2008)
» TruSystem 7500: New OR Table from TRUMPF (November 21, 2008)
» New Scanning Methods Detect Brain Trauma (November 21, 2008)
» Developing the Next Generation of DBS Devices (November 20, 2008)
» Valeo Silicon Nitride Ceramic Spacers Get CE Mark (November 17, 2008)
» PlasmaBlade Finds New Uses With New Attachments (October 29, 2008)
» Infrascanner, an Intracranial Hematoma Detector, Goes on Sale in Europe (October 21, 2008)
» Bion Implantable Nerve Stimulator for Chronic Headache (October 14, 2008)
» Wellex Interspinous Process Medical Device Wins CE Mark (October 10, 2008)
» The BeamPath NEURO System: First Flexible CO2 Laser Scalpel (September 23, 2008)
» Eon Mini, World's Smallest Spinal Cord Stimulator, Makes Clinical Debut (September 17, 2008)
» Live Wireless Monitoring of Chemical Activity of the Brain (September 16, 2008)
» Brain Stem Meets MARVEL (September 15, 2008)
» Solex Goes for The Jugular: New Heat Exchange Catheter Gets FDA OK (September 10, 2008)
» Digital Lightbox Brings Minority Report to The OR (No Precognition Capabilities) (August 19, 2008)
» Long Lasting Spinal Cord Neurostimulator from St. Jude Gains Approvals (August 13, 2008)
» Color Changing Crystals for Detecting Brain Trauma (August 11, 2008)
» Physio-L Lumbar Artificial Elastomeric Disc Gets EU OK (August 7, 2008)
» Hydrogel as a Repair Device for Torn Cartilages (August 4, 2008)
» NeuroPace: Maybe First Since Jesus to Prevent and Treat Epilepsy (August 4, 2008)
» V Series Neuro Clot Retrievers from Concentric (July 30, 2008)
» Force-feedback Offerings from Haption (July 28, 2008)
» PlasmaBlade System Gets FDA Go Ahead (July 24, 2008)
» SlimFuse Cervical Plate Goes On Sale (July 24, 2008)
» CombiCarrier II Wins Silver for Good Design (July 18, 2008)
» Daysimeter Helps to Study Light's Effects (July 15, 2008)
» G-Wire: Visually Positioned Guidewire for Faster, Safer Procedures (June 30, 2008)
» Battling Migraines From the Inside and Out (June 27, 2008)
» Smart Brain-Computer Interface Learns with the Brain (June 27, 2008)
» LDR Receives 510(k) for Spinal Transforaminal Approach Implant (May 29, 2008)
» SpineAssist Gets New FDA Approval (May 28, 2008)
» The Third Install in the US of Aquilion ONE CT from Toshiba (May 21, 2008)
» Demand Is High for Brilliance iCT, a 256-Slice CT from Philips (May 19, 2008)
» neuroArm Performs First Surgery (May 19, 2008)
» Peak PlasmaBlade Wants to Be The New Bovie (May 7, 2008)
» Gore Receives EU's CE Mark for PRECLUDE Vessel Guard (May 7, 2008)
» LimiTorr Volume Limiting Cerebral Spinal Fluid Drainage System (April 29, 2008)
» New Data Shows that Deep Brain Stimulation Useful for Severe, Treatment Resistant Depression and OCD (April 28, 2008)
» St. Jude Receives Patent for Anti Depression Neurostimulation Method (April 22, 2008)
» World's Smallest Spinal Cord Stimulator Approved in US, Europe (April 14, 2008)
» AutoLITT Laser Interstitial Thermal Therapy System (April 2, 2008)
» Ornim Oxygen Saturation System FDA Approved (March 20, 2008)
» Spinal Non-fusion Technology from Raymedica (March 17, 2008)
» Canada OK's Oxiplex® Gel Adhesion Barrier for Spine Surgery (March 5, 2008)
» What Drives the NeuroArm (February 22, 2008)
» Leica M720 OH5: Another Premium to Be a Neurosurgeon (February 22, 2008)
» Eon Promises Longer Lasting Neurostimulation (February 14, 2008)
» St. Jude Begins Trial of Deep Brain Stimulation for Depression (February 8, 2008)
» OrNim's Targeted Oximetry (January 30, 2008)
» Total Recall (January 30, 2008)
» Brain Stimulation Device for Stroke Victims Fails Clinical Trial (January 25, 2008)
» Penumbra System Approved in US for Post Stroke Revascularization (January 15, 2008)
» Surgilux: Surgery Without Stitches (January 2, 2008)
» In the Works: Photoacoustic Tomography Device (December 17, 2007)
» Somatom Definition AS: The World's First Adaptive Computed Tomograph (December 6, 2007)
» AquilionONE CT from Toshiba Cleared by FDA (November 27, 2007)
» FusionOptic™ Technology from Leica (November 16, 2007)
» Tessellation of Brain MRI Images to Help with Surgical Planning (November 13, 2007)
» Non-Contact 3D Med Display (November 7, 2007)
» NeuroArm Robot Promises to Revolutionise MRI-guided Neurosurgery (November 7, 2007)
» Wireless EEG Powered by Body Heat (October 31, 2007)
» X-STOP® IPD® Procedure (September 28, 2007)
» Scientists Develop Better Gauging of Brain Blood Flows (September 12, 2007)
» The Top of Your Head is Apparently Worth $4000 (August 30, 2007)
» Vagus Nerve Stimulation Shows Success in Study (August 20, 2007)
» Deep Brain Stimulation Therapy for MCS (August 17, 2007)
» Implant for Potential Treatment of Epilepsy (August 15, 2007)
» Treating Cancer with Electric Fields (August 3, 2007)
» Medtronic's Cervical Discs Deliver Good News to the Company (July 18, 2007)
» MEMS-based Pressure Systems from ISSYS (July 10, 2007)
» 3-D Ultrasound Provides Window on the Brain (June 21, 2007)
» Auditory Nerve Implants Improve on Cochlear Implants (June 19, 2007)
» EndoSite 3Di Digital Vision System Now Used for Thoracic and Neuro Cases (June 15, 2007)
» Lets Get It On: Liquid Web Connects Nerves to Eletrodes (June 14, 2007)
» Neurosurgeons, Just Cut Out the Glowing Tissue (June 13, 2007)
» Miniature Neurosurgical Robot Wins Award (June 5, 2007)
» Simultaneous Imaging of the Brain by MRI and PET (May 25, 2007)
» Medtronic's Bryan® Cervical Disc System (May 25, 2007)
» NeuroArm: Navigating the Future of Surgery (April 18, 2007)
» StaXx® FX Structural Kyphoplasty System (April 18, 2007)
» Flexible Electronics for Brain Injury Research (April 6, 2007)
» NovoTTF-100A for Glioblastoma Multiforme (March 30, 2007)
» World's First 'Spinal Transplant' Completed (March 26, 2007)
» iPlan® BOLD MRI Mapping (March 1, 2007)
» Pilot Study of Genesis® Neurostimulation System in Angina (February 28, 2007)
» Expanded Endonasal Approach is Safe and Efffective in Peds (February 22, 2007)
» Cyberkinetics Requests Humanitarian Waiver to Sell Nerve Growth Stimulation System (February 21, 2007)
» 3mensio™ Technology: Medical Visualization and Surgical Planning Software (January 26, 2007)
» Axiom Artis dBA Twin (January 24, 2007)
» New Ideas on Developing Thought-Controlled Artificial Limbs (January 19, 2007)
» Second Sight Medical Retinal Prosthesis Receives FDA Approval for Clinical Trials (January 10, 2007)
» ActiveCare DVT®: Goes with Patient; Goes to Cleveland (December 27, 2006)
» ELANA: Nonocclusive Intracranial Bypass Surgery (December 20, 2006)
» Robots Provide 24/7 Care for Stroke Patients (November 17, 2006)
» Thought-Driven Computer Control by ALS Patient (October 16, 2006)
» Teenager Plays Space Invaders with His Mind (October 11, 2006)
» H2S Offers Hope in Total Circulatory Arrest (October 10, 2006)
» RestoreADVANCED™, PrimeADVANCED™ Neurostimulators (October 9, 2006)
» MPH® Hemostatic Technology (October 3, 2006)
» PRESTIGE® Cervical Disc System (September 21, 2006)
» The Arctic Sun® (September 13, 2006)
» Preemptive Treatment of Seizures by VNS? (September 5, 2006)
» Leksell Gamma Knife® PERFEXION™ System (August 11, 2006)
» Live Surface, A Software for Surgeons (August 2, 2006)
» More Neuroendovascular Fun: The Penumbra Stroke System (July 18, 2006)
» O-arm™ Imaging System (July 10, 2006)
» Cyberonics VNS System in the Literature (July 6, 2006)
» Ultrasound Technology for Counting Emboli (June 26, 2006)
» Utah Electrode Array to Control Bionic Arm (May 24, 2006)
» Eon™ Rechargeable Neurostimulation System (May 8, 2006)
» The Northstar Stroke Recovery System (May 5, 2006)
» Neurosurgical News (May 4, 2006)
» The SpineJet, A Water Scalpel (May 1, 2006)
» Deep Brain Stimulation Shows Promise in Treatment of Obsessive Compulsive Disorder (April 27, 2006)
» I-space Medical Imaging (April 25, 2006)
» Scan2Knit (April 19, 2006)
» Just Call Her the Robo-Chick (April 6, 2006)
» Medtronic RestorePRIME Neurostimulation System (March 30, 2006)
» Wireless C-Arms from Xograph (March 3, 2006)
» Neurological Devices: Developed enough for a 2-page AP Article (February 28, 2006)
» Fonar 360°™: A Room-Size MR Scanner (November 14, 2005)
» New C-Spine Surgery Technique Developed (November 7, 2005)
» Operating Suite Opens for "Nose Jobs" (October 19, 2005)
» First Human Implants of BioDisc™ (September 6, 2005)
» Machines, software model helping to create better spinal implants (July 27, 2005)
» Onyx Liquid Embolic Approved by FDA (July 22, 2005)
» Novalis® Shaped Beam Surgery (June 27, 2005)
» Adaptive Prosthetics (April 28, 2005)
» DARPA Encourages a Prosthetic Revolution (April 12, 2005)
» DuraSeal™ (April 11, 2005)
» Trilogy™ Technology for Image-Guided Radiosurgery (April 8, 2005)
» Cervical-Stim® by Orthofix (March 28, 2005)
» The BioScanIR System (March 23, 2005)
» Virtual 3D surgical patient (February 10, 2005)
» Oscillating field stimulator for injured spinal cords (January 17, 2005)
» BrainGate Neural Interface System (January 14, 2005)
» Charite (December 24, 2004)
» IGSonic (December 14, 2004)
