Wednesday, May 7, 2008
Peak PlasmaBlade Wants to Be The New Bovie
PEAK Surgical, Inc. from Palo Alto, CA hates the bovie cutter/coagulator. The company cannot stand the 1920's technology behind the bovie, and how its thermal function destroys healthy patient tissue around the cut. What do we hate about the bovie? Well, you know: all those bovie induced burns and destroyed gloves that surgeons are regularly subjected to.
Long story short, PEAK Surgical wants its Peak PlasmaBlade, a cold cutter and coagulator, to be the bovie of the 21st century. The company is quite hopeful: a new study presented in a poster session at the ongoing American College of Obstetricians and Gynecologists' (ACOG) 56th Annual Clinical Meeting in New Orleans showed that PEAK PlasmaBlade™ "cut freshly excised human abdominal tissue with little thermal tissue injury compared with traditional electrosurgery."
More about the technology:
Electrosurgery was invented in the beginning of the 20th century and became one of the most-often used surgical tools after William Bovie introduced his electrosurgery (radiofrequency) generator in 1926. Since then, electrosurgical cutting has been performed using continuous radiofrequency waveforms, which thermally vaporizes soft tissue via an electrical arc through air and Joule heating. This results in a cutting and coagulation action that leaves a wide zone of collateral thermal damage.By contrast, PEAK Surgical’s PULSAR Generator supplies pulsed waveforms that produce short plasma-mediated, highly controlled electrical discharges through extensively insulated electrodes on a handheld device -- the PEAK PlasmaBlade. Because the radiofrequency is provided in short pulses with low duty cycle (fraction of time the voltage is ON), and the PEAK PlasmaBlade is so highly insulated, heat diffusion and associated thermal damage to surrounding tissues is limited, resulting in greatly reduced collateral damage and extreme cutting precision.
PEAK Surgical’s technology including the pulsed plasma-mediated discharges and electrode insulation techniques were originally developed by Professor Daniel Palanker’s group at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University. They have been evaluated in ophthalmic applications, including human studies in retinal and cataract surgery – one of the most delicate, precise and difficult types of surgery, and in preclinical studies.
Check out the following product brochure distributed by PEAK Surgical:
Product page: Peak PlasmaBlade...
Press release: PEAK Surgical Announces Positive Results from Preclinical Study of PEAK PlasmaBlade™ for Obstetric and Gynecologic Surgery
Video demonstrating the device...
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Wednesday, May 7, 2008
Gore Receives EU's CE Mark for PRECLUDE Vessel Guard
Gore & Associates has received EU's approval to market its PRECLUDE vessel guard, developed to provide protection for vasculature following anterior spinal surgery for degenerative disc disease, just in case if these surgical patients have to return for a revision procedure. Anterior vertebral re-explorations have inherently increased risks of damage to major abdominal vessels, such as the aorta, the vena cava, and the iliacs.
GORE PRECLUDE Vessel Guard enables vasculature management in patients having undergone anterior spinal surgery for degenerative disc disease, including artificial disc replacement (ADR), where scarring around the aorta, vena cava, and iliac vessels can complicate revising, repositioning, or removing a disc prosthesis. An ideal biomaterial for intimate vessel contact and protection, GORE PRECLUDE Vessel Guard is soft and conformable with excellent handling characteristics. The tight microstructured membrane is inserted between the prosthesis and the vessels during the primary surgery. In a revision surgery, the vessels can be identified, dissected from the device and mobilized. GORE PRECLUDE Vessel Guard has a three-layer construction with two outer layers consisting of a tight expanded polytetrafluoroethylene (ePTFE) microstructure preventing penetration by fibroblasts, thus minimizing vascular tissue attachment to the device, allowing safer anterior revision. GORE PRECLUDE Vessel Guard is also easy to use--an elastomeric inner layer minimizes impingement and provides the stiffness needed for accurate placement. The material may be trimmed and tailored without fraying.The U.S. Food & Drug Administration (FDA) cleared GORE PRECLUDE Vessel Guard indicated for vessel protection in August 2006.
Press release: Gore Receives CE Mark for GORE PRECLUDE® Vessel Guard
Video (Windows Media): 14-Month Revision Surgery with a GORE ePTFE Membrane
Product page...
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Tuesday, April 29, 2008
LimiTorr Volume Limiting Cerebral Spinal Fluid Drainage System
Integra LifeSciences is introducing its new CSF drainage system that features a shutoff valve that activates when a preset amount of fluid enters the bag, increasing the safety of the patient as well as reducing the workload on nurses that otherwise have to manually monitor the level.
The LimiTorr(TM) Volume Limiting CSF Drainage System can be used for both lumbar and ventricular drainage. It includes a volume-limiting valve mechanism, which halts drainage when the pre-determined volume of 20 mL or 30 mL is met. This safety mechanism helps prevent CSF overdrainage, which can lead to subdural hematomas, brainstem herniation or death.CSF drainage is an important component of managing the intracranial pressure of a neuro-compromised patient or a patient undergoing abdominal aortic aneurysm surgery. "This product increases patient safety, and reduces the stress of those caring for patients undergoing lumbar subarachnoid or cranial CSF drainage; it's also safer than other devices I have used," said Dr. McDermott.
Dr. McDermott had clinicians in mind, as well as patient safety, when he envisioned the LimiTorr(TM) system. "For patients, this device reduces the likelihood of CSF overdrainage. For nurses, the device helps reduce the anxiety associated with having to constantly monitor the drainage volume to prevent CSF overdrainage, and allows them to devote more time to other patient care issues."
Press release: Integra LifeSciences Announces Launch of the LimiTorr Volume Limiting CSF Drainage System
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Monday, April 28, 2008
New Data Shows that Deep Brain Stimulation Useful for Severe, Treatment Resistant Depression and OCD
The idea that deep brain stimulation could become a useful treatment for a variety of drug resistant psychiatric disorders is not new to us or to our readers. To review, you can just take a look at many flashbacks at the end of this post. Now the news is that at the upcoming annual scientific meeting of the American Association of Neurological Surgeons (AANS), the data to be presented by Ali Rezai, M.D., a neurosurgeon at the Cleveland Clinic, will again point to usefulness of deep brain stimulation (DBS) for severe, treatment resistant depression and obsessive compulsive disorder (OCD).
From the statement by Medtronic:
The data represent the largest and longest clinical experience to date with DBS for psychiatric disorders and was collected through the collaborative research efforts of several leading institutions. All of the studies being presented used the Medtronic DBS system to stimulate a target within the brain called the ventral anterior limb of the internal capsule/ventral striatum (VC/VS), which is a central node in the neural circuits that regulate mood and anxiety.“The data we are presenting on 43 patients is the result of more than 10 years of work across multiple institutions worldwide. These data represent the largest number and the longest evaluation of patients with psychiatric disorders who have undergone DBS implants, including some with long-term follow up,” said Dr. Rezai, who represented an international working group of physicians studying DBS therapy for treatment resistant OCD and depression. “While OCD and depression treatment with DBS require additional clinical evaluation research, our early open-label experience to date is encouraging and indicates that DBS may help severely disabled and suffering patients who have exhausted other treatment options.”
Flashbacks: St. Jude Begins Trial of Deep Brain Stimulation for Depression ; Deep Brain Stimulation Shows Promise in Treatment of Obsessive Compulsive Disorder; Deep Brain Stimulation Therapy for MCS; Deep Brain Stimulation Awakens Patient; St. Jude Receives Patent for Anti Depression Neurostimulation Method; Brain Implant Relieves Depression
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Tuesday, April 22, 2008
St. Jude Receives Patent for Anti Depression Neurostimulation Method
St. Jude Medical has received a patent from the US Patent and Trademark Office for their deep brain stimulation technology that focuses on Brodmann Area 25 to treat severe, refractory depression.
Brodmann Area 25 is a structure within the subcollosal gyrus region of the brain. It is the focus of the St. Jude Medical BROADEN(TM) (Brodmann Area 25 DEep brain Neuromodulation) study, which is evaluating whether deep brain stimulation (DBS) therapy can help people who suffer from major depressive disorder, a severe form of depression. This study is being conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE), which was announced in February 2008."This patent is a cornerstone in developing our approach to deep brain stimulation for depression, which is the leading cause of disability in the U.S. among illnesses," said Chris Chavez, president of St. Jude Medical's ANS Division. "The BROADEN study provides hope for a meaningful new therapy to the millions of patients still seeking treatment for their severe depression."
On April 4, St. Jude Medical enrolled the first patient, a woman from Chicago, in the BROADEN study. The patient will be implanted with the Libra(R) Deep Brain Stimulation System, an investigational device, at Alexian Brothers Behavioral Health Hospital in Chicago.
Full patent: Method of treating depression, mood disorders and anxiety disorders using neuromodulation...
Press release: St. Jude Medical Awarded U.S. Patent for Neurostimulation Therapy for Depression
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Monday, April 14, 2008
World's Smallest Spinal Cord Stimulator Approved in US, Europe
St. Jude Medical just announced that the company's rechargeable, longest-lasting Eon Mini implantable neurostimulator has received approval from the FDA, as well as a CE Mark from the EU.
Even with its small size, the Eon Mini has the longest-lasting battery life of any rechargeable spinal cord stimulation (SCS) device in its class. It is the only small rechargeable neurostimulator to receive a 10-year battery longevity approval by the FDA. For patients this means the device should provide sustainable therapy and maintain a reasonable recharge interval for 10 years of use at high settings. The device’s battery longevity also may mean that patients require fewer battery replacement surgeries.
The Eon Mini also allows patients the freedom to comfortably recharge the device’s battery while taking a walk, cooking a meal or shopping because the charging system is fully portable. Additionally, Eon Mini has the greatest recommended implant depth of any small rechargeable SCS device, so the device can be placed more discreetly, potentially making it less noticeable.In addition, the Eon Mini device features the following:
Enhanced microchip and software (NeuroDynamix™) technology that continuously selects the most efficient power management mode, preserving the battery’s capacity to deliver therapy.
Constant current circuitry that automatically adjusts power output to deliver consistent therapy over time.
Advanced programming capability that allows physicians to treat up to eight pain areas simultaneously to address complex pain patterns.
A 16-contact header that is compatible with all St. Jude Medical SCS leads, giving physicians more control in designing the system for optimal pain relief.
Product page: The Eon Neurostimulation System...
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Wednesday, April 2, 2008
AutoLITT Laser Interstitial Thermal Therapy System
Michigan Live is reporting that Winnipeg, Canada-based Monteris Medical Inc. "will establish an office in Kalamazoo this month and begin testing its technology on humans in two Cleveland hospitals next month, Monteris Chief Executive Officer James W. Duncan said Tuesday." 
The company is developing a minimally invasive, MRI-guided laser interstitial thermal therapy system called AutoLITT™, designed for the treatment of primary brain cancers, such as glioblastoma multiforme. The move is thought to represent the company's strategy in obtaining FDA approval of the product by the end of this year, and in laying the foundation for establishing manufacturing facilities in Michigan.
A quick glance at technology:
Focused-LITT is made possible by Monteris™ novel AutoLITT™ System. It consists of state-of-the-art capital equipment, proprietary imaging and treatment management software, and novel single-use application tools.Probe. A thin (3mm), side-firing, internally-cooled laser probe is inserted into the tumor, similar to brain biopsy procedures.
Probe Driver. The control mechanism enables the surgeon to have axial and rotational control over probe positioning, with hand controls analogous to endoscope controls. The surgeon is able to direct the laser beam to all parts of the tumor by simply rotating the probe and moving up and down.
Laser. A standard surgical laser with approximately 1064nm wavelength (e.g Nd:YAG or tuned diode laser) is connected through MRI-compatible umbilicals to the probe and probe driver.
Treatment Planning Software. Interactive software enables the surgeon to image the probe, tumor and surrounding brain tissue to determine the optimal treatment strategy and ablation sequences.
Treatment Monitoring Software. Interactive software enables the surgeon to real-time visualize laser firing direction, the resultant thermal "bloom," and tissue that has reached thermal damage threshold (i.e. ablated), overlaid upon real-time images of the tumor and surrounding brain.
MRI. A standard 1.5T MRI (or higher) imager is required--available in most hospitals.
Check out the product page for AutoLITT™ system and this video demonstrating how the product works...
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Thursday, March 20, 2008
Ornim Oxygen Saturation System FDA Approved
Ornim Medical, out of Lod, Israel, just received FDA approval for its non-invasive cerebral oxygen monitor for use during surgeries. Back in January, we've profiled OrNim's Targeted Oximetry as a potential diagnostic modality not just for the brain, but for monitoring oxygenation of other organs, such as viscera or extremities.
From Globes Online:
OrNim's Ultrasound Tagged Light technology - UTLight, transmits a beam of light through tissue to measure the absorption of light by oxygenated and deoxygenated hemoglobin. The system tags the light with ultrasound beams enabling to bypass superficial tissue, and measure absolute oxygen saturation levels within the monitored tissue.Shechter explains, "If the blood in the area marked by the ultrasound is red and oxygen-rich, it absorbs more tagged light. If the area is light and oxygen-poor, more tagged light is reflected back to us. In this way, we can precisely measure oxygen levels."
More at Globes...
FDA press release: Ornim receives FDA 510(K) clearance (.pdf)...
Flashback: OrNim's Targeted Oximetry
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Monday, March 17, 2008
Spinal Non-fusion Technology from Raymedica
Raymedica, Inc., a Minneapolis-based developer and manufacturer of prosthetic disc nuclei aimed at preserving the motion of the spine, has been recognized by Frost & Sullivan at the 2008 Excellence in Medical Technologies & Life Sciences Awards. 
The company has developed two product platforms, called PDN-SOLO® and HydraFlex™, both thought to be designed for treatment of patients that "fall in gap of being under-treated by a discectomy but over-treated by more invasive spine surgery," according to Frost & Sullivan. The FDA has granted an approval for the company to perform a clinical evaluation of its HydraFlex Nucleus Arthroplasty System for the treatment of DDD.
Here's what Raymedica says about its HydraFlex device, that features the firm's proprietary hydrogel technology:
Nucleus Arthroplasty non-fusion technology goes beyond nucleus replacement and involves a comprehensive systematic approach to DDD. It is not only the implant that is important in Nucleus Arthroplasty motion preservation procedures, but the consideration of many factors including proper patient selection, indications, surgical technique/approach, and post-operative rehabilitation. Nucleus Arthroplasty motion preservation technology involves a complete spectrum of treatment. The systematic approach of Nucleus Arthroplasty motion preservation technology is better suited to providing predictable and successful outcomes than the device-only approach of nucleus replacement...Implanted via an Anterior lateral RetroPeritoneal Approach (ARPA), the HydraFlex device is designed to replace the diseased nucleus potentially providing pain relief and maintaining disc height. The HydraFlex device is designed with the Company’s same proprietary pre-formed contained hydrogel technology that has been implanted in over 4,000 patients over the past 10 years.
The HydraFlex Nucleus Arthroplasty System has distinct design features that provide a more anatomic contoured shaped device for greater fit and fill; a softer core with a larger footprint to potentially reduce the risk of subsidence; and faster hydration to allow faster stabilization in comparison to the Company’s pioneering PDN-SOLO® design. The HydraFlex NAS™ incorporates new co-functioning instrumentation that is designed to provide repeatable/reproducible intra-discal sizing with consistent placement of the device during implantation. The ARPA permits a more thorough consistent nucleus cleanout, the ability to repair the annular incision, and is a less destabilizing approach. This device and system approach is collectively designed to potentially improve clinical performance.
Product page: HydraFlex™ Nucleus Arthroplasty System™...
Nucleus Arthroplasty™ motion preservation technology...
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Wednesday, March 5, 2008
Canada OK's Oxiplex® Gel Adhesion Barrier for Spine Surgery
FzioMed, Inc., out of San Luis Obispo, CA, is reporting that Health Canada has approved the company's Oxiplex® gel for use in lumbar spine surgery. The company's bioabsorbable gel is composed of biocompatible medical polymers, carboxymethylcellulose (CMC) and polyethylene oxide (PEO). Designated as a medical device, the gel is applied to roots of spinal nerves during lumbar laminectomy. 
It is touted to create a "temporary, protective barrier against the damaging effects of excessive fibrosis, inflammation and other irritants that can lead to recurrent postoperative pain." The company reports that its product has been successfully used in 49 countries (including the European Union) and in more than 100,000 surgeries.
Details about the technology:
Key characteristics of FzioMed's biomaterial science:Non-Animal and Non-Bacterial. FzioMed biomaterials contain no animal or bacterial by-products.
Biocompatible. Pre-clinical and clinical data have demonstrated the safety and biocompatibility of FzioMed biomaterials when used in a variety of surgical procedures. The polymers CMC and PEO have been used extensively for decades in the medical device and pharmaceutical industries. Over 90,000 spine surgery patients have been treated safely with our world-leading Oxiplex/SP Gel.
Bioabsorbable. FzioMed biomaterials are naturally absorbed by the body over time and cleared via normal processes. They do not need to be removed after application.
Tissue Adherent. FzioMed biomaterials can be formulated to adhere to tissues, so that they remain in place for a period of time for site-specific applications.
Versatile. FzioMed biomaterials can be formulated into a variety of bioabsorbable product types - gels, films, solutions, foams, sponges, and powders - with specific characteristics such as tissue adherence, elasticity, strength, viscosity and absorption. This allows us to tailor products for use in targeted medical applications.
Handling, Packaging & Storage. FzioMed products can be stored at room temperature and are provided sterile and ready to use. They require no mixing or assembly before use.
Press release: FzioMed's Oxiplex Gel for Spine Surgery Approved in Canada...
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Friday, February 22, 2008
What Drives the NeuroArm
New details have emerged about NeuroArm, the world's first MRI-guided neurosurgical robot at the University of Calgary, designed to function within the high magnetic field of an MRI environment. Massachusetts-based Johnson Medtech, a subsidiary of Hong Kong's Johnson Electric, is the company that takes credit for the ceramic motors that give the arm its mobility. Furthermore, we have uncovered an interesting video (below) that gives more details on this whole NeuroArm project.
From the press release by Johnson Medtech:
Working with a team of experts from the University of Calgary and MacDonald, Dettwiler and Associates Ltd. (MDA), Nanomotion of the Johnson Medtech network collaborated to implement non-magnetic actuators that enable the precision motion necessary for conducting microsurgical operations safely within the strong magnetic field of an MRI system. In the past, the magnetic nature of electric motors and their metal components restricted surgeons and surgical tools from the MRI environment, making motion impossible.The neuroArm utilizes sixteen of Nanomotion’s HR2-1-N-3 piezo ultrasonic nonmagnetic motors, coupled with the company’s AB5 drive module. These motors cover six joints, all of which are rotary. Using the real-time visibility into the human body provided by the MRI, the sophisticated Nanomotion actuators in the neuroArm enable surgeons to manipulate tools at a microscopic scale and conduct surgeries that were previously difficult or impossible.
“Our design team overcame a number of challenges in building the neuroArm. One was the need for the neuroArm to operate in the strong magnetic field of the MRI, and with extreme precision,” said Dr. Garnette Sutherland, Professor of Neurosurgery, University of Calgary. “Nanomotion’s non-magnetic piezo ultrasonic motors enable the neuroArm to effectively conduct microsurgical operations within the MRI environment.”
In addition to the non-magnetic benefit of the ceramic motors, Nanomotion’s precision motion control abilities increase the granularity with which a surgeon can work, from within an eighth of an inch using the human hand, to within the width of a hair using the neuroArm. These sophisticated motors provide surgeons with unprecedented detail and control, enabling them to manipulate tools at a microscopic scale.
The video:
Johnson Electric - JEMedtech...
Flashbacks: NeuroArm: Navigating the Future of Surgery ; NeuroArm Robot Promises to Revolutionise MRI-guided Neurosurgery
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Leica M720 OH5: Another Premium to Be a Neurosurgeon
Leica Microsystems has announced a new neurosurgical microscope that features specially designed compact optics that supposedly will make operating much more comfortable for the surgeons.
The following is from the press release:
By incorporating horizontal optics for the first time, Leica Microsystems is writing a groundbreaking chapter in the history of optics design. The optics carrier is so compact that the surgeon naturally adopts a healthy working posture. Whatever the position of the patient, even sitting upright, operations can be performed without arm, back or neck strain. The microscope allows hours of fatigue-free work.A significant increase in working space with variable focus provides free access to the operating area, greater instrument maneuverability and an optimal view. The Leica M720 OH5 supports the surgeon as he works; he can see more and see better, work even more safely and generally benefit from the perfect ergonomics.
No two people are the same. Thanks to individually adjustable components, the Leica M720 surgical microscope provides optimal ergonomic conditions for concentrated and precise work and an excellent view. The two binocular tubes have a swivel range of 115° and feature the innovative butterfly technique, which enables the eyepieces to be swung to a second viewing plane with a simple hand movement. If desired, the tube can be locked in one of five defined positions simply by pressing the ErgoLock™ button. This improves the ergonomics and the stability, which is a particular advantage when using a mouth switch. The microscope can therefore be matched optimally to both the surgeon and his assistant, irrespective of body height, position of the operating area or the microscope.
Thanks to the SpeedSpot™ feature, a simple hand movement focuses the microscope -- there is no need to follow the movement through the eyepiece. If the two laser spots overlay, the surgeon can be sure of a razor-sharp image. As a focusing reference, SpeedSpot™ guarantees a brilliant image at all ports (surgeon, assistant, documentation).
The Leica M720 OH5 surgical microscope ideally combines original Leica APO OptiChrome™ Optics and a 300 Watt xenon illumination system to give the surgeon a steady clear and sharply focused image for the entire duration of the operation.
As working distance decreases, the maximum possible light intensity value is reduced: The working distance-controlled BrightCare™ feature ensures that the light intensity does not surpass safety levels. The magnification-controlled illumination diameter AutoIris™ automatically matches the illuminated area to the field of view. This prevents heating of tissue outside the surgeon's field of observation.
The patented mobility concept of the Leica OH5 stand is based on the proven OH4 system. Thanks to its magnificent reach, it offers the surgeon and the whole operating team a level of maneuverability unattained by competitor products. The system is remarkable for its precise and harmonious balance of maneuverability and extremely easy movement.
Product page: Leica M720 OH5...
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Thursday, February 14, 2008
Eon Promises Longer Lasting Neurostimulation
St. Jude Medical has received both FDA approval and EU's CE Mark for an upgraded version of its Eon device for spinal cord stimulation therapy. The device promises to run on once a day recharges for ten years after implantation, reducing the need of surgical replacement of the battery in the future:
With neurostimulation therapy, devices with rechargeable batteries have quickly become the standard. At high stimulation parameters, a 10-year-old Eon device will maintain at least 24 hours of continuous therapy between recharges. For patients, this means the Eon device can provide sustainable therapy and maintain a reasonable recharge interval for 10 years, potentially resulting in fewer battery replacement surgeries.Rechargeable neurostimulators are designed with a battery reserve to protect the device from damage should a patient discontinue therapy. The Eon neurostimulator's battery reserve allows the device to be safely recharged for up to 18 months after stimulation has been discontinued.
"We continually strive to develop best-in-class products that enhance patients' quality of life," said Chris Chavez, president of St. Jude Medical's ANS Division. "The addition of battery life-extending technology, which enables the 10-year battery capability, is a prime example of our commitment to making a good product even better."Introduced in March 2005, the Eon neurostimulator was upgraded in September 2006 with NeuroDynamix(TM) technology, a proprietary microchip and enhanced software design, which contribute to the increased battery efficiency. The claim was granted after St. Jude Medical monitored the device's performance since the initial product introduction in 2005.
Press release: St. Jude Medical Receives FDA and CE Mark Approvals of Extended 10-Year Battery Life Claim for Rechargeable Neurostimulator
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Friday, February 8, 2008
St. Jude Begins Trial of Deep Brain Stimulation for Depression
St. Jude Medical just received an Investigational Device Exemption (IDE) from the FDA that will allow the company to proceed with an extensive clinical trial of deep brain stimulation for the treatment of depression in patients that have failed other available forms of therapy.
Drs. Mayberg and Lozano conducted the first study of deep brain stimulation (DBS) for depression in Toronto, Canada, in 2003 and published their findings in Neuron in March 2005. As reported in this journal article, imaging studies led them to an area of the brain thought to be involved in depression called Brodmann Area 25. This area appears to become overactive when people are profoundly sad and depressed.St. Jude Medical owns the intellectual property rights and has various patents pending for the use of neurostimulation at Brodmann Area 25. The Libra(R) Deep Brain Stimulation System, which is being evaluated in this study, is designed to deliver mild electrical pulses from a device implanted near the collarbone and connected to small electrical leads placed at specific targets in the brain.
To be eligible for the study, participants must:-- Currently be diagnosed with major depressive disorder
-- Be between 21 and 70 years old, with onset of first episode
before age 45-- Have tried at least four treatments in their current episode,
such as different medications, various combinations of
medications or electroconvulsive therapy-- Have been depressed for at least one year.
Press release: St. Jude Medical Announces Clinical Study of Deep Brain Stimulation for Depression
Study page: BROADEN™ Clinical Study
Flashbacks: Brain Implant Relieves Depression; Deep Brain Stimulation Shows Promise in Treatment of Obsessive Compulsive Disorder
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Wednesday, January 30, 2008
OrNim's Targeted Oximetry
OrNim, a Lod, Israel company, has developed a non-invasive laser-based sensor for direct monitoring of oxygen levels within the brain. The company is trying to break into a lucrative market of cerebral perfusion monitoring, currently dominated by such devices as INVOS Cerebral Oximeter from Somanetics Corp. Unlike its competitiors, OrNim believes its monitor could potentially be used for monitoring a variety of organs, from brain to viscera.
From the company's technology page:
... pulse oximetry is an optical based technology that is used to measure oxygen levels within the arterial blood. It works by attaching a non-invasive probe to a patient (usually placed on the ear, finger, or toe) which transmits a beam of light through the patient’s blood vessels. This technology works by measuring the differences in absorption of different wavelengths of light by oxygenated and deoxygenated hemoglobin. Pulse oximetry has markedly improved medical care – particularly in the fields of anesthesiology and intensive care – and as a result has been rapidly adopted by the medical community. However, pulse oximetry is subject to a number of limitations – most notably, the technology cannot penetrate deep tissue, it is sensitive to ambient light levels and remains limited to peripheral perfusion (e.g. the finger). Tissue oximetry, a technology capable of penetrating deep tissue, remains qualitative in nature (i.e. it cannot provide an absolute measurement of blood oxygen saturation).OrNim is introducing a breakthrough technology that enables localized, quantitative measurements of oxygen saturation levels from deep tissue volumes. OrNim’s sensors are capable of performing Targeted Oximetry - allowing caregivers the ability to pinpoint specific regions of the body, bypass peripheral tissue, and measure oxygen saturation levels within the monitored tissue.
The ability to locally monitor tissue oxygenation is particularly important in the instance of monitoring oxygen saturation within cerebral tissue. The Company’s technology is capable of filtering out the contribution of external tissue to the measured signal - thereby providing a “clean” reading of oxygen saturation from only the tissue that is targeted.
This is a revolutionary application as prior methods of quantitatively measuring oxygen in specific deep tissue tended to be invasive (i.e. requiring a surgical procedure), narrowly localized, and subject to environmental interference.
In addition to monitoring tissue oxygenation, Targeted Oximetry is inherently capable of monitoring other vital parameters. As a result, the technology can also be used to detect the presence and extent of hemorrhages within the monitored tissue, or changes in blood perfusion to the tissue.
With quantitative cerebral oximetry, patient outcome can be improved. Additionally, intensive care (ICU) patient stay and costs associated with patient treatment can be significantly reduced. It is essential to determine a patient’s absolute oxygenation for managing his/her therapy. In cases where the patient’s condition is unknown prior to start of procedure, qualitative modalities are inefficient.
OrNim’s first product will assist physicians in preventing and reducing neurological damage that frequently occurs during traumatic brain injury, stroke, or following cardiac arrest.
More at MIT Tech Review...
Company page: OrNim...
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Total Recall
At Toronto Western Hospital in Ontario, neurosurgeons seem to have stumbled on a surprising discovery when a patient receiving deep-brain hypothalamus stimulation therapy had clear memory recalls of things he long forgot.
A limited clinical study being conducted to follow up on that finding is so far pointing to similar results.
The accidental breakthrough came during an experiment originally intended to suppress the obese man's appetite, using the increasingly successful technique of deep-brain stimulation. Electrodes were pushed into the man's brain and stimulated with an electric current. Instead of losing appetite, the patient instead had an intense experience of déjà vu. He recalled, in intricate detail, a scene from 30 years earlier. More tests showed his ability to learn was dramatically improved when the current was switched on and his brain stimulated.Scientists are now applying the technique in the first trial of the treatment in patients with Alzheimer's disease. If successful, it could offer hope to sufferers from the degenerative condition, which affects 450,000 people in Britain alone, by providing a "pacemaker" for the brain.
Three patients have been treated and initial results are promising, according to Andres Lozano, a professor of neurosurgery at the Toronto Western Hospital, Ontario, who is leading the research.
Professor Lozano said: "This is the first time that anyone has had electrodes implanted in the brain which have been shown to improve memory. We are driving the activity of the brain by increasing its sensitivity – turning up the volume of the memory circuits. Any event that involves the memory circuits is more likely to be stored and retained..."
The man, who has not been identified, was also tested on his ability to learn lists of paired objects. After three weeks of continuous hypothalamic stimulation, his performance on two learning tests was significantly improved. He was also much more likely to remember a list of unrelated paired objects with the electrodes turned on than when turned off.
Speaking to The Independent yesterday, Professor Lozano said: "His performance improved dramatically. As we turned the current up, we first drove his memory circuits and improved his learning. As we increased the intensity of the current, we got spontaneous memories of discrete events. At a certain intensity, he would slash to the scene [in the park]. When the intensity was increased further, he got more detail but, when the current was turned off, it rapidly decayed."
The discovery surprised the scientists as the hypothalamus has not usually been identified as a seat of memory. The contacts that most readily produced the memories were located close to a structure called the fornix, an arched bundle of fibres that carries signals within the limbic system, which is involved in memory and emotions and is situated next to the hypothalamus.
More at The Independent...
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Friday, January 25, 2008
Brain Stimulation Device for Stroke Victims Fails Clinical Trial
An implantable neural stimulator called Renova™ from Northstar Neuroscience failed a crucial clinical trial evaluating the effectiveness of cortical stimulation and rehab for motor recovery in patients with stroke.
Northstar Neuroscience, Inc. (NASDAQ: NSTR), a medical device company developing therapies for the treatment of neurological diseases and disorders, today announced that its EVEREST(a) pivotal trial evaluating cortical stimulation to improve hand and arm function in stroke survivors did not meet its primary efficacy endpoint.The EVEREST trial was designed to determine whether cortical stimulation in conjunction with rehabilitation therapy would lead to greater gains in hand and arm function and activities of daily living than rehabilitation therapy alone. At the four-week follow-up, 30.8% of the patients receiving cortical stimulation achieved the threshold of clinically meaningful improvement for the composite primary efficacy endpoint defined in the study protocol, compared to 29.1% of the patients in the control group. The primary efficacy endpoint required a 20% absolute difference between these two groups and thus the endpoint was not met. Secondary analyses of the components of the primary endpoint also failed to show a statistically meaningful difference between investigational and control subjects.
The company is currently collecting and processing longer-term data through 24 weeks, as well as other secondary endpoints. While our analysis of this data is not complete, based on preliminary review the company does not believe that this analysis, once completed, will demonstrate sufficient evidence of efficacy to support a pre-market approval (PMA) submission to the FDA.
Press release: Northstar Neuroscience Announces Primary Endpoint Results of EVEREST Clinical Trial ...
Product page: Renova Cortical Stimulation System ...
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Tuesday, January 15, 2008
Penumbra System Approved in US for Post Stroke Revascularization
The Penumbra System, a clot-retrieval technology that we were watching since 2006 while it was undergoing clinical trials, has received an FDA nod for use in the revascularization of patients with acute ischemic stroke.
The Penumbra System is a package of tools used by neuro interventional specialists to remove occlusions from the large vessels of the brain that are causing an acute ischemic stroke. It works on the proximal surface of the occlusion, optimizing safety and eliminating the need for navigation beyond the occlusion. The Penumbra System is comprised of an aspiration platform containing multiple devices that are size-matched to the specific neurovascular anatomy allowing clots to be gently aspirated out of intracranial vessels.In the pivotal trial, in addition to