ENT Archive

Monday, February 8, 2010

Medtronic's ENT Scope Sheath Proves Effective for Germicidal Protection

A study out of Boston University School of Medicine, presented last week at the annual Triological Society meeting, has looked into the effectiveness of Medtronic's Slide-On Sensory Sheath as an alternative to germicidal immersion for flexible nasopharyngolaryngoscopes in between procedures. The condom-like device is wrapped over the fiber optic cable to prevent ENT scopes from getting dirty in the first place. The scope still requires an "enzymatic detergent cleaning and disinfection with 70 percent alcohol" when switching between patients, but the Slide-On should still save time during busy use of the scope.

From a Medtronic statement:

Microbial study results show that sterile disposable sheaths, when used with endoscopes, are as effective as using a liquid germicidal system for disinfecting scopes between patient procedures and provide protection against cross-contamination equivalent to immersion in germicidal solutions.
The Medtronic Slide-On™ EndoSheath® System is a sterile, disposable cover for flexible endoscopes that provides a latex-free barrier between the scope and the patient. The system is designed to reduce patient contact with organic debris and staff exposure to hazardous chemicals. The study authors noted that the system is an alternative to time-intensive chemical reprocessing, allows for quick scope turnaround and helps physicians maximize time treating patients.

Press release: Study Suggests Slide-On Endosheath System Provides Several Advantages Over Traditional Germicidal Immersion ...

Product page: Slide-On™ Sensory Sheath ...

Flashbacks: Slide-On™ Sensory Sheath for ENT

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Monday, February 8, 2010

Dental Hearing Aid Technology from Sonitus Medical

Sonitus Medical out of San Mateo, California is a company that's betting on bone conducting dental hearing implant technology. The SoundBite Hearing System that the firm is developing consists of a unit that has a microphone and wireless transmitter, and a tiny speaker that attaches to rear teeth to resonate and transmit the audio mechanically to the cochleae. The idea for this technology is not new and maybe risky, but Sonitus Medical seems confident it can earn regulatory approval and introduce an all new hearing aid technology to market.

The SoundBite hearing system consists of both a BTE (behind the ear) microphone unit, housing the receiver, wireless transmitter, and attached microphone, and a discreet, removable ITM (in the mouth) hearing device. An inductive charger unit is provided to charge the BTE microphone unit and ITM hearing device.
SoundBite is designed to detect sound using a tiny microphone placed in an open-fit dome within the ear canal of the impaired ear. This nearly invisible microphone is attached by a thin tube to a transmitter unit called a BTE worn behind the ear. Placing the microphone in the ear canal is intended to allow the SoundBite hearing system to capitalize on the natural acoustic benefit provided by the patient's own pinna or outer ear to capture and direct sound.

Once sound is captured by the microphone, it is processed by the BTE digital audio device. The BTE wirelessly transmits sound to the removable ITM (in the mouth) hearing device, which is custom made for your own teeth for optimal comfort and function. The ITM hearing device in turn uses advanced technology to produce imperceptible sound vibrations that are conducted via the teeth, through bone, to the both cochleae. In this way, the SoundBite hearing system is intended to provide clear, high fidelity sound and thus restore normal hearing to patients who are essentially deaf in one ear with no surgery or modifications to the teeth required.

SoundBite hearing system is intended for patients who suffer from single sided deafness, conductive hearing loss, or mixed hearing loss and seek a non-surgical, non-invasive, hearing device that delivers high fidelity sound.

Product page: SoundBite ...

(hat tip: ScienceRoll)

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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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Wednesday, December 23, 2009

Esteem Totally Implantable Hearing Device On Track for US Approval

Last Friday we reported that the FDA's Ear, Nose, and Throat Advisory Committee has met to discuss whether to recommend approval of Envoy Medical's (St. Paul, Minn) fully implantable hearing aid. Now word is that the group unanimously voted to suggest giving the go ahead to allow marketing of the Esteem device in the US.

More details in the press release: FDA Advisory Panel Votes 15 to 0 in Favor of Approving Envoy Medical's Esteem® Fully Implantable Hearing Restoration System...

Flashback: Esteem Totally Implantable Hearing Device Under Consideration for Approval in US

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Tuesday, December 22, 2009

A Christmas Gift to Intuitive Surgical: TransOral Robotic Surgery Gets FDA Approval

The FDA has given the go ahead for surgeons to use robotic surgery for procedures in the throat and nearby regions by going through the mouth. In effect, this is a new indication for the Da Vinci Surgical System from Intuitive Medical, as it is the only robot of its type that can be used to perform the procedures. The transoral applications of robotic surgery have been developed at the University of Pennsylvania School of Medicine, where a special center was created to study the subject.

Drs. Gregory S. Weinstein and Bert W. O’Malley, Jr. of the University of Pennsylvania School of Medicine’s Department of Otorhinolaryngology: Head and Neck Surgery founded the world’s first TransOral Robotic Surgery (TORS) program at Penn Medicine in 2004, where they developed and researched the TORS approach for a variety of robotic surgical neck approaches for both malignant and benign tumors of the mouth, voice box, tonsil, tongue and other parts of the throat. Since 2005, approximately 350 Penn patients have participated in the world’s first prospective clinical trials of TORS.
Head and neck tumor treatments often involve a combination of surgery, radiation therapy, and chemotherapy. In many cases, surgery offers the greatest chance of cure; yet conventional surgery may require an almost ear-to-ear incision across the throat or splitting the jaw, resulting in speech and swallowing deficits for patients. In comparison, the minimally invasive TORS approach, which accesses the surgical site through the mouth, has been shown to improve long term swallowing function and reduce risk of infection while speeding up the recovery time. When compared to traditional surgeries, after their cancers have been removed successfully, patients have been able to begin swallowing on their own sooner and leave the hospital earlier. TORS outcomes are markedly improved when compared to standard chemotherapy, radiation or traditional open surgical approaches for oropharyngeal cancer.

Press release: FDA Clears TransOral Robotic Surgery - Developed at Penn -for Tumors of Mouth, Throat and Voice Box...

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Friday, December 18, 2009

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.

Monday, December 14, 2009

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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Thursday, December 3, 2009

Artificial Larynx to Give Mute a New Voice

Using touch sensors, the Palatometer from CompleteSpeech of Orem, Utah is capable of reading how one's tongue contacts the palate during speech. Developed to help people with speech impediments learn how to speak properly, the device is now being used by research scientists from the University of the Witwatersrand in Johannesburg, South Africa to develop an artificial larynx that can digitally vocalize the speech of mute people.

From Technology Review:

To use the device, a person puts the palatometer in her mouth and mouths words normally. The system tries to translate those mouth movements into words before reproducing them on a small sound synthesizer, perhaps tucked into a shirt pocket.
So far, Russell has trained the system to recognize 50 common English words by saying each word multiple times with the palatometer in her mouth. The information can be represented on a binary space-time graph and put into a database. Each time the user speaks, the contact patterns are compared against the database to identify the correct word.

Russell's team has tested the word-identification system using a variety of techniques. One approach involves aligning and averaging the data produced while training the device for a few instances of a word to create a template for comparison. Another compares features such as the area of the data plots on the graph, and the center of mass on the X and Y axes. A voting system compares the results of selected methods to see whether there is agreement. The researchers have also tested a predictive-analysis system, which considers the last word mouthed to help determine the next.

More from Technology Review: A Tongue-Tracking Artificial Larynx...

Link: CompleteSpeech Palotometer...

Image: Top: CompleteSpeech's palatometer. Bottom: The space-time graph of the tongue-palate contact pattern for the word "been."

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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...

Product brochure... (.pdf)

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Tuesday, November 10, 2009

A New LED Powered Endoscope from Schölly

Schölly Fiberoptic out of Denzlingen, Germany is releasing a new video bronchoscope with CMOS "chip-in-the-tip" and bright LED technology. The device is going to be unveiled at MEDICA 2009 next week in Düsseldorf.

The controller unit is plug-and-play with easy start-up. Its compact size saves table space and the simple controls eliminate the need for lengthy training. The controller is completely silent since it does not require a cooling fan. All video settings are preprogrammed, so no complicated and time consuming set-up is necessary. A single cable leads from the controller to the ergonomic handpiece. The handpiece includes the tip deflection lever, working channel port, suction valve, and buttons for taking photos and illumination adjustment. High-powered LEDs are incorporated inside the handpiece. These LEDs eliminate the need for costly replacement bulbs.

Link: Innovative New Video Bronchoscope with DeepVu Technology ...

(hat tip: German Healthcare Export Group)

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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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Tuesday, October 20, 2009

Single Chip Stereo Endoscopy from Visionsense Coming to an OR Near You

Visionsense out of Orangeburg, New York, a company that makes single chip 3D endoscopic vision technology, has raised $8M in VC funds to begin full scale marketing of its unique technology in the US and Europe. The firm's Visionsense Stereoscopic Vision System, designed to improve depth perception and understanding of complex surgical anatomy, can be used for a variety of complex surgeries, such as skull-base and keyhole neurosurgical cases, as well as a wide range of laparoscopic procedures.

Camera Control Unit (CCU) – The CCU consists of a single Pentium PC with proprietary Visionsense hardware and software.

3D Stereoscopic Display - The CCU connects to a stereoscopic display with flexible arm for multiple viewing angles (requires glasses).

Video Cart - specifically designed to maximize surgeon ergonomics and minimize the footprint in the operating room.

The VSII is designed to work with:

Cameras - The VSII uses various configurations of cameras specifically designed for transnasal and keyhole neurosurgical applications. Currently, there are 2 lengths (170mm and 300mm) and 2 angles (0 and 30 degree). The cameras are able to be sterilized and are reusable for 40 procedures.

LED Light Source - The VSII uses its own customized light source which uses a few watts of power to illuminate the surgical field.

Digital Recording/playing/editing procedures, in both mono and stereo

Product page: VSII -Visionsense Stereoscopic Vision System

Flashback: Single Chip Stereo Endoscopy from Visionsense

(hat tip: Globes)

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Wednesday, October 14, 2009

Touch Controls Is The Latest Feature in Hearing Aids from Starkey Labs

Starkey Laboratories has released a new line of hearing aids that sport a touch sensitive pad, similar to that on most laptops, which allows the user to control the volume and change between different sets of settings all without any buttons. Inspired by the Apple iPod scroll wheel, the S Series™ BTE with Sweep™ Technology is water resistant, which probably means you can take a shower while wearing one. Another nifty feature is the ability of the hearing aid to recognize the standard tones produced by telephones. This means you can use any phone as a remote to control the settings.

Features of the four models in the S Series from the product page:

Traditional hearing aid buttons, switches and dials are often difficult for patients to find and manipulate. With Sweep Technology, there is no mechanical movement required for activation, no push buttons that oxidize and fail with time, and no openings around the volume control wheel that allow moisture and dirt to enter the hearing aid. The sweep surface is a single seamless control, giving patients full access to volume, memory and standby controls — smarter technology that makes patients' lives simpler.

The new S Series BTE is a flexible option that can be fit with standard earmolds or open with thin tubing. The instrument includes Advanced HydraShield™, Starkey's proprietary moisture and corrosion protection system, as well as T2, giving patients the ability to adjust hearing aid volume or memories with a touch-tone phone. The instrument was designed for optimal patient acceptance, utilizing the same design language as the award-winning S Series receiver-in-canal (RIC).

The new BTE with Sweep Technology rounds out Starkey's S Series with Drive Architecture™ line of hearing instruments, which already includes completely-in-canal, in-the-canal and in-the-ear styles, along with a full RIC family, in four technology levels. Drive Architecture triples the processing power of previous platforms, enabling industry-leading feedback cancellation, superior integrated noise management, live real ear measurement, and much more. It is engineered from the ground up to deliver maximum performance, comfort and personalization.

Here's a video showing the touch control pad in use:

Press release: Starkey Introduces Sweeping Changes to Hearing Aids; Touch Screen Meets Hearing Aid in New S Series BTE

Product page: S Series

S Series brochure...

Starkey's technical paper on the Sweep technology...

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Tuesday, October 13, 2009

SoundBite, a Cochlear Hearing Aid Without The Implant

Cleveland Clinic has released its annual Top 10 Medical Innovations, a list that answers the question: "What game-changing medical technology, device, or therapy do you see breaking through in 2010?" At the top of the list is SoundBite, a bone conduction hearing system from Sonitus Medical, a firm out of San Mateo, California, that may bring some serious competition to the cochlear implant market, specifically for people suffering for a single sided deafness. Currently awaiting FDA approval, the system uses teeth as a sound conducting medium, instead of a cranium where cochlear aids are being typically implanted nowadays. Being much less conspicuous, the system should be a popular choice if it gets regulatory approval.

Merging the well-known principles of bone conduction together with advanced wireless and sound processing technology, SoundBite is the world's first non-surgical and removable bone conduction hearing system, which is designed to transmit sound via the teeth. The SoundBite hearing system consists of both a behind the ear device, housing the receiver, wireless transmitter, and attached microphone, and a discreet, removable, custom-fit retainer-like device. An inductive charger unit is provided to charge the behind the ear device and retainer.

SoundBite is designed to detect sounds using a small microphone placed within the open ear canal of the impaired ear. The nearly invisible, thin tube microphone is attached to the transmitter unit worn behind the ear. This microphone placement in the pinna or outer ear is intended to allow the SoundBite hearing system to capitalize on the natural acoustic ability of the outer ear to capture and direct sound into the open ear. SoundBite system hearing is intended to provide clear, high fidelity sound and is designed to restore normal hearing to patients.

From the microphone, SoundBite hearing system will receive sound in the transmitter unit worn behind the ear. This nearly invisible, digital audio device wirelessly transmits sound to the removable dental retainer-like device, which is custom fitted by a partner dentist for optimal comfort and function. The retainer uses advanced technology and specialized electronics to produce imperceptible vibrations that are conducted via the teeth and bones, to the both cochleae. No surgery is required.

Press release: Sonitus Medical Technology Ranks #1 on Cleveland Clinic's 'Top 10' Medical Innovations for 2010...

Product page: SoundBite hearing system...

Cleveland Clinic: Top 10 Medical Innovations for 2010...

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Wednesday, September 23, 2009

ImThera's Targeted Hypoglossal Neurostimulation Therapy for Obstructive Sleep Apnea

Hypoglossal nerve stimulation for treatment of obstructive sleep apnea is a promising technology being pursued by a number of companies, including big firms such as Medtronic. The big idea is that muscles of the upper airway relax more than necessary in some OSA patients, the passage gets blocked and air can't flow repeatedly during sleep. Hence hypoglossal stimulation, properly timed to one's breathing, can help to relieve the obstruction. ImThera, a start up out of San Diego, California, is now reporting that it has developed a new neurostimulation solution for people that failed to find a less invasive therapy for their obstructive sleep apnea (i.e. CPAP mask) The aura 6000 implant provides night time electric stimulation to the hypoglossal nerve. The firm has yet to receive regulatory approval to market the device.

Components of the aura 6000:

Implanted
A multi-contact electrode specific to the Hypoglossal nerve. The electrode connects to the IPG via a lead wire.

An implantable pulse generator (IPG) enclosure which contains the electronics and the RF receive-transmit antenna. It is externally programmable, specifically for each patient, and re-chargeable.

External

Patient's controller, charger and programmer device. The external controller interfaces to the IPG for patient functions and to the physician's computer for set-up and programming.

Physician's PC including the aura600 Clinical Manager software.

Product page: aura 6000...

Press release: ImThera Medical Completes Development of Targeted Hypoglossal Neurostimulation Treatment for OSA... (.pdf)

Flashbacks: Apnex Hypoglossal Nerve Stimulation for OSA ; Inspire II Implantable Nerve Stimulator for Obstructive Sleep Apnea

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Tuesday, September 8, 2009

Nucleus 5 Smallest Cochlear Implant Gets US OK

Cochlear, Ltd (Lane Cove, NSW, Australia) has won FDA approval to market the Nucleus 5 device for people with severe-to-profound hearing loss. The titanium device is the smallest of its kind. Nucleus 5 sports a two way remote control, telephone connectivity, and proprietary sound processing technology.

Smallest sound processor — for a comfortable and discreet fit. The Nucleus 5 Sound Processor is smaller than any other and designed to fit comfortably and securely. Yet, it is tough and secure enough for any situation.
Features the most flexible options to anticipate your needs – from an extensive selection of wearable options for every age and lifestyle, to music, phone and entertainment accessories and easy connection options, we’ve anticipated your everyday needs.

Thinnest titanium implant design — Ideal choice for all ages. The Nucleus 5 System features the thinnest titanium implant in the industry. It is 40% thinner than our previous generation and 30% thinner than any other titanium implant available.

Nucleus 5 is the world’s most water resistant allowing you to relax around water or play by the pool. With the industry’s only International Protection Rating of IP44 18 you have the assurance that your sound processor can keep up with your active lifestyle, even around water.

The exclusive two-way remote assistant is an added bonus to your system. Gives you the added flexibility and control of being able to adjust your settings easily from the remote assistant or directly on the sound processor – and gives parents the added peace of mind that their child is hearing their best.

Also allows the easiest bilateral use. With the Nucleus 5 System if you have chosen to go bilateral (with cochlear implants for both ears) your two sound processors can be easily and simultaneously controlled with the exclusive two-way remote assistant.

Product page: Nucleus 5...

Press release: Cochlear Americas Announces FDA Approval of the Nucleus(R) 5 System

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Thursday, August 6, 2009

MED-EL's Vibrant Soundbridge Middle Ear Implant Gets EU OK

MED-EL out of Tyrol, Austria has received European approval to market the Vibrant Soundbridge middle ear implant system for children and adolescents. The device features a single point connection to the skull, so the system can remain permanent as it accommodates the patient's head growth.

From the product page:

The implanted part of the Vibrant Soundbridge is called the VORP (Vibrating Ossicular Prosthesis) and consists of an internal coil, a magnet to hold the Audio Processor over the implant, a demodulator, the conductor link and the innovative technology of the Floating Mass Transducer™ (FMT™).
The signal from the Audio Processor is transmitted to the VORP and transformed into mechanical vibrations by the FMT.

The VORP is implanted during a surgical procedure in which the FMT is attached to a vibratory structure of the ear. When activated, the FMT vibrates in a controlled manner, specific to each patient's hearing needs, causing the structure of the ear to vibrate. It conducts a wide frequency range up to 8000 Hz.

The FMT, a tiny magnet, lies at the core of this advanced technology.

The externally worn Audio Processor (AP) is attached to the patient's head, behind the ear, by a magnet which is attracted to a magnet within the implanted VORP.

The Audio Processor includes a microphone to pick up sound from the environment, sound processing circuitry to modify the output signal to the patient's specific requirements, a battery to power the device and high-quality, fully digital signal processing.

The Audio Processor is designed to have a battery life of approximately one week.

Product page: Vibrant Soundbridge

Press release: VIBRANT SOUNDBRIDGE received market approval for the implantation in children and adolescents within Europe and countries that recognize the European CE mark

Flashbacks: MED-EL Corporation's new Cochlear Implant System ; DUET Electric-Acoustic Hybrid Hearing Aid Undergoing US Trials...; Earworm: A Symphony Borne of Science...

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Tuesday, August 4, 2009

FDA OK's PlasmaBlade for Tonsil and Adenoid Tissue Removal

Peak Surgical out of Palo Alto, California has received FDA approval for its tonsil and adenoid tissue dissection device. The PEAK PlasmaBlade TnA, which features interchangeable tips, is based on the recently introduced PlasmaBlade system that aims to replace the Bovie as a standard dissection and coagulation device. The primary advantage of PEAK's technology is the low thermal footprint of the cutting tip, leading to less damage to the tissue around the dissection site.

All of the PlasmaBlade tissue dissection surgical devices are used in conjunction with PEAK Surgical’s PULSAR Generator, which supplies pulsed waveforms that produce short plasma-mediated electrical discharges through the PlasmaBlade. Because the radiofrequency is provided in short on-and-off pulses with low duty cycle, and the blade is insulated, heat diffusion and associated heat damage to surrounding tissues is limited, resulting in less collateral damage and more precise tissue dissection. In contrast, most radiofrequency-based surgical devices use continuous voltage waveforms and un-insulated electrodes to cut tissue.
The PlasmaBlade provides surgeons with a single device that offers:

* the precision of a traditional scalpel;
* the bleeding control of traditional electrosurgery technology;
* minimized thermal damage;
* the ability to quickly and easily cut through all types of soft tissue, including skin, fat and muscle;
* the ability to operate in a wet or dry surgical field.

Product page: PlasmaBlade Family...

Press release: PEAK Surgical Introduces PEAK PlasmaBlade™TnA...

Flashbacks: PlasmaBlade Finds New Uses With New Attachments; PlasmaBlade System Gets FDA Go Ahead; Peak PlasmaBlade Wants to Be The New Bovie

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Monday, July 27, 2009

Plato's Cave: New 3D Visualization System

A new radiology visualization platform, called Plato's Cave, has been implemented at The Methodist Hospital in Houston. The engineers and clinicians have pulled expertise from a number of companies in the industry to develop a system that can be utilized for advanced radiology readings or as a technology to perform preoperative surgical planning for advanced cases, such as intracranial aneurysms or facial surgery. The system uses a projector to display images on a screen and specialized glasses to show them in three dimensions. The physician can use a traditional video game controller to navigate through the volumetric visualization.

In Plato’s “Allegory of the Cave,” prisoners saw shadows on a cave wall as reality and blindly accepted it as fact. One day, a prisoner escaped and actually saw the outside world; thus, his experience gave him a more expansive view of reality. Butler calls his venture “Plato’s Cave” because this new visual approach to medicine opens up a whole new world for physicians and patients.
Currently, radiation oncologists have limited views of individual slices of the body. However, with this technology, physicians can see inside a patient’s body. By using “Plato’s Cave,” these physicians can maneuver around organs in all directions, allowing them to see more clearly how radiation is deposited around tumors, adjacent organs, arteries, veins, and lymphatics.

“Previously, when we were planning a patient’s treatment, the data might have indicated that a higher than desired dose of radiation would be delivered to a particular organ such as the spinal cord; yet, we were unable to visualize the precise location of that dose or divert it,” Butler said. “Now, I am able to actually see the distribution and have the option to maneuver the excess dose away from the area and deposit it elsewhere.”

Surgeons can also use this technology to their advantage. It will give them the ability to visualize, before the patient arrives in the operating room, potential anatomical obstacles that could complicate performing a procedure.

“For instance, if a surgeon is performing a liver resection, we can simulate removing part of the patient’s liver, and with the push of a button determine how much of the remaining liver will be viable after the operation,” Butler said. “If it’s 20 percent or greater, the procedure can be performed; if less, it cannot. This will take surgical planning to a whole new level.”

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