Thoracic Surgery Archive

Monday, June 22, 2009

Bronchoscopic Biologic Lung Volume Reduction (BLVR) System from Aeris Therapeutics Aims on Emphysema

The market for technologies designed to treat emphysema and its symptoms is heating up, according to the experts at the Millennium Research Group. The "medical technology market intelligence" company believes that there is a number of products that are working through the clinical trials that are expected to receive FDA approval sometimes in the next five to ten years. One potential treatment is the Biologic Lung Volume Reduction (BLVR) system from Aeris Therapeutics (Woburn, MA). The company's system aims to slowly collapse diseased parts of the lungs through bronchoscopically delivered specialized injections ("proprietary mixture of drugs and biologics"), reducing the organ in size and improving the ventilation/perfusion relationships in patients with severe emphysema. As any medical student knows, improvement in a V/Q mismatch means improvement in oxygenation, and improvement in symptoms.

From the product page:

With BLVR, a physician uses a bronchoscope to direct treatment to the most damaged areas of the patient’s lungs. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a bioabsorbable gel. The gel is comprised of clotting proteins that deliver the treatment, an antibiotic to prevent infection and drugs designed to remodel damaged areas of the lungs—actually using the body’s natural scar formation response to permanently collapse the diseased areas. This reduction in lung volume creates more space for adjacent healthier parts of the lungs to function more effectively. The gel polymerizes quickly after delivery so it does not migrate to non-targeted areas of the lung. In addition, since no implant remains in the body, it obviates the risks of long-term infection, implant migration or tissue reaction.
Aeris Therapeutics has completed Phase 2 clinical trials of BLVR. Results indicate that BLVR is well tolerated and is associated with significant improvements in breathing function, symptoms and quality of life.

System info page: Biologic Lung Volume Reduction System

Press release: Broncus Technologies' Exhale Stent and Other New Devices to Prompt Robust Growth In Emphysema Treatment Market, According to Millennium Research Group

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Monday, June 22, 2009

Steerable Biopsy Needle Helps Target Difficult Sites

Another technology we discovered browsing through the press releases is a targeting biopsy needle developed especially for accessing lung tissue. The Seeker Steerable Biopsy Needle™ from PneumRX (Mountain View, California) provides 360° thumb control to help guide placement to the exact target spot in lung parenchyma, with a hope of avoiding the dreadful pneumothorax.

From the product page:

The Seeker Steerable Biopsy Needle™ allows you to make fine adjustments in intra-parenchymal needle trajectory using the joystick controlled stylet. This promotes increased targeting accuracy and decreases repetitive needle passes.
The Seeker Steerable Biopsy Needle™ lumen features a large cross sectional area made possible by a thinner walled needle design. This offers the potential to collect more tissue, facilitating a more reliable diagnosis.

Video demonstrating the movement of the Seeker needle:

Product brochure: Seeker Steerable Biopsy Needle...

Press release: Broncus Technologies' Exhale Stent and Other New Devices to Prompt Robust Growth In Emphysema Treatment Market, According to Millennium Research Group...

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Thursday, May 28, 2009

PMI Gets Approval for Powered Minimally Invasive Surgical Tools

The FDA has given 510(k) clearance to Power Medical Interventions (Langhorne, Pennsylvania) for the firm's iDrive Intelligent Power Unit, detachable Intelligent Surgical Instruments and iConsole device. The company believes that its powered tools, that sport a high level of articulation, can make a lot of difficult laparoscopies much easier to perform.

More about the components from PMI:

A first-of-its-kind breakthrough in operating room instrumentation, the iDrive is designed to support a variety of minimally invasive procedures by offering surgeons a broad range of cutting and stapling configurations combined with increased flexibility, access and precision. The iDrive is a novel hand-held, computer-controlled power unit to which any of the company's Intelligent Surgical Instruments can be attached. This innovation allows all of PMI's Intelligent Surgical Instruments to be driven by a single power unit. As a result, hospitals will be able to acquire PMI's advanced technology platform at less than half of the current cost, which may lead to significant savings for hospitals. The potential now exists for a comprehensive surgical solution that may be significantly less expensive than manual surgical stapling devices. In addition, the iDrive is reusable, easy to use, cost effective, and less wasteful, potentially leading to savings for hospitals and health networks.
The iConsole is a proprietary wireless device that communicates directly with the iDrive during surgical procedures to output specific auditory and visual reference information via its speaker and liquid crystal display. Outputs provide surgeons with important information regarding calibration, firing, and instrument and reload type, allowing surgeons to make real-time, critical decisions that may ultimately lead to an improved patient outcome.

The iDrive and iConsole combination represents a dynamic technology solution which is designed to enable the incorporation of important functional enhancements. PMI intends to aggressively pursue and implement a variety of key enhancements, which ultimately could lead to offering surgeons the world's first wireless computer mediated platform with unprecedented capabilities such as wireless video processing, Internet access, a patient record interface and controlled tissue compression software.

Press release: Power Medical Interventions(r) Receives 510(k) Clearance to Market iDrive Intelligent Power Unit(tm) With iConsole(tm)

Link: PMI Intelligent Surgical Instrument page

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Tuesday, May 19, 2009

Bronchial Thermoplasty Does Well in AIR2 Trial

Asthmatx, Inc. of Sunnyvale, California, a developer of the Alair® bronchial thermoplasty device, designed to reduce the amount of smooth muscles in the airway walls of small to medium size airways, is reporting positive results from the Asthma Intervention Research 2 (AIR2) Trial. The system, reported by us on a couple of occasions before, uses a probe inserted into the lungs to deliver radiofrequency induced heat to reduce smooth muscle within airways. Bronchial thermoplasty, as the procedure is called, has been undergoing clinical trials in a bid to receive regulatory approval. The latest trial involved about 300 asthmatics and has shown that extreme asthma attacks were reduced by 32 percent in a select group of patients, and that 84 percent fewer trips to the emergency room occurred in the patient group.

More about Alair bronchial thermoplasty from Asthmatx website::

The AIR2 Trial was designed to evaluate the safety and effectiveness of bronchial thermoplasty in adult patients with severe asthma who were symptomatic, despite being treated with high doses of standard of care medications (high dose inhaled corticosteroids and long-acting bronchodilators). The study was a randomized, double-blind, sham-controlled trial and enrolled 297 patients at 30 sites in 6 countries. The primary effectiveness endpoint was the change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score. Safety was assessed by comparing the short and long-term safety profiles for both the treatment and sham control
groups.

Key statistically significant clinical findings of the AIR2 Trial were:

Improvement in the average AQLQ score at 6-, 9-, and 12 months over sham control

4 out of 5 Alair-treated patients responded with a clinically significant improvement in AQLQ compared to 64% of sham controls

32% reduction in asthma attacks

84% reduction in emergency room visits for respiratory symptoms

36% reduction in patients reporting episodes of asthma (multiple symptoms) adverse events

66% reduction in days lost from work/school or other activities due to respiratory symptoms

In the period immediately following bronchial thermoplasty, there is an expected increase and worsening of respiratory-related symptoms, which are of the type expected following bronchoscopy in patients with asthma. These events typically occur within a day of the procedure and resolve on average within 7 days with standard care. In the long term, fewer bronchial thermoplasty treated patients reported respiratory adverse events and there was a significant decrease in patients reporting asthma (multiple symptoms) adverse events in the Alair-treated group compared to the sham control group.

"The results from AIR2, similar to the results from two prior randomized clinical trials evaluating the Alair System, demonstrate that patients with severe asthma can experience clinically significant improvements in their asthma control and their quality of life," said Glen French, CEO of Asthmatx.

The results of this pivotal study have enabled Asthmatx to submit a Premarket Approval application (PMA) to the FDA for regulatory approval. The FDA granted the Alair System PMA Expedited Review Status in October 2008, based on it's potential "to treat asthma, a lifethreatening/debilitating disease" and because the "Alair System offers a breakthrough technology which has the potential to address an unmet clinical need within the asthma
population."

Press release: Pivotal Data Show Bronchial Thermoplasty Can Improve Quality of Life and Reduce Asthma Attacks and Emergency Room Visits for Adults with Severe Asthma...

System info page: Alair® System

Flashbacks: Alair System May Become Option for Asthmatics ; The Alair® System for Bronchial Thermoplasty™

Animation below the fold demonstrates the functionality of the procedure:

Wednesday, May 13, 2009

BrainLab's Digital Lightbox Getting an Upgrade

BrainLab AG is planning on releasing an updated version of its Digital Lightbox multitouch clinical display. Still reminding us of a giant iPhone, the unit interfaces with EMRs to display and manipulate clinical images easily and intuitively, essentially making the keyboard or any other interface device unnecessary.

Here's what the company tells Medgadget about the new features in the latest release of the Digital Lightbox scheduled for this summer:

The new Video-input feature allows the integration of data on the Digital Lightbox, when it is located in the OR, from sources like micro-, endo- and arthroscopes; and video signals can be streamed from the OR and displayed on the Digital Lightbox when it is positioned in surgeons' offices or meeting rooms. This feature extends the range of application into new medical subspecialties, strengthening the value of Digital Lightbox as a core multi-disciplinary platform for hospital information networks.
When version 1.0 came to the market, a number of customers wanted the Digital Lightbox in rooms dedicated for teaching, patient education, tumor boards and internal meetings. The new External Display-out feature makes it possible to connect the Digital Lightbox to one or more additional displays or projectors, in or outside the room. This makes it more versatile for use in situations when large groups of medical experts come together and the even the 30" display of the Digital Lightbox isn't big enough.

Digital Lightbox also serves as the viewing display and remote control for VectorVision flex, combining an image-guided surgery platform with large-scale viewing, and fast data access and manipulation.

Here's a company video demonstrating the system:

Product page: Digital Lightbox

Flashback: Digital Lightbox Brings Minority Report to The OR (No Precognition Capabilities)

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Thursday, May 7, 2009

NASA Super Plastic in Medtronic CRT

Medtronic won FDA approval, and is consequently making available, the Attain Ability® left-heart lead (Model 4196) for use with cardiac resynchronization devices. The lead is composed of an advanced aerospace resin, named Langley Research Center's Soluble Imide, or LaRC-SI, and is the first time material developed by NASA has been used in implantable medical devices.

From the Langley Research Center:

LaRC-SI is a wholly aromatic high-performance thermoplastic polyimide that is a selfbonding/non-curing resin made from commercially available monomers. This polyimide has superior mechanical, electrical, and adhesive properties and an extensive range of processing choices that allow it to serve as either a dielectric inner layer, substrate coating, or the substrate. LaRC-SI film is made by casting or spraying a solution consisting of xylene, N-methyl-pyrrolidinone (NMP), and LaRC-SI powder. At different drying temperatures, various amounts of solvent are removed to the point where it becomes insoluble but retains its melt processability. LaRC-SI excels in the following characteristics:
Solubility in conventional high-boiling solvents

Melt flow and bonding properties

Electrical properties -- low dissipation factor and high dielectric strength

Resistance to harsh environments such as radiation, cryogenic and elevated temperatures, most fluids, corrosives, and biological inertness

It is highly flexible, resistant to chemicals, and withstands extreme hot and cold temperatures. The "super plastic" was determined to be biologically inert, making it suitable for medical use, including implantable devices.

Medtronic states that the Attain Ability™ lead wire one of the thinnest left-heart AICD leads available and this affords the ability to choose between different sites on the endocardium to deliver the lead for optimal therapy.

Here's a Medtronic animation showing the placement of the device:

Press release: FDA Approves New Medtronic Left Heart Lead for Cardiac Resynchronization Therapy Devices ...

NASA : Polymer Coats Leads on Implantable Medical Device...

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Tuesday, May 5, 2009

Robotic System May Help With Lung Biopsy Procedures

Lung biopsies can be difficult procedures to perform while maintaining precision on a moving organ is of utmost importance. To increase the accuracy of radiologists placing the biopsy needle exactly where needed, a collaboration between researchers at Massachusetts General Hospital and MIT created the Robopsy robotic assist system. This technology is essentially a remotely guided needle that is imaged under CT as the physician manipulates it in a real time.

Here's more about the device from Robopsy's website:

A small, CT compliant, lightweight, disposable actuator device that can grip, orient and insert a biopsy needle will sit upon the patient right inside the CT gantry. This device will be coupled to nondisposable control electronics and a control interface to enable a doctor to carry out the biopsy insertion from the radiation shielded control room, while imaging simultaneously.

Patient care is of paramount importance. Robopsy will facilitate earlier, more accurate diagnoses, as initial trials indicate that lesions smaller than 5 mm can be targeted. The rate of pneumothorax will decrease as a result of fewer failed pleural penetrations. We estimate that procedure times will be cut from 120 to 60 minutes resulting in less anesthetized time for the patient as well as a per-procedure cost saving of around $1000 and increased CT scanner throughput. Doctors will also sustain reduced radiation dosages since some current procedures cannot be successfully performed without simultaneous scanning and the lead-vested doctor’s presence patient-side.

Robopsy was designed in close collaboration with the MGH Radiology department to address doctors’ specific needs. It represents a much-needed evolution, rather than a revolution, and is expected to integrate seamlessly into the existing procedure. The doctor will remain in complete control and will be responsible for closing the imaging-actuation loop by observing real-time CT images while remotely controlling the needle’s position with an intuitive software interface. From the patient’s perspective, Robopsy can be thought of as providing doctors with an extended third hand, which is immune to radiation, does not tremor, and has pin-point accuracy.

Device page: Robopsy ...

Monday, May 4, 2009

Magnus Operating Table from Maquet

MAQUET has just unveiled improvements to its Magnus operating table, a system that can position the patient into virtually any surgical position, and at the same time accommodate patients weighing up to 250 kilograms.

From the press release:

An optimum exposure area is achieved in combination with gravitational force and the operating table's extreme tilting and tipping functionality. The tilt angle of up to 80º and canting angle of up to 45º combined with the system's fully compatible modules open up virtually unlimited positioning possibilities. "This way a patient weighing up to 250 kilograms can be brought into any possible position. MAGNUS is thus fast approaching its vision of the "floating" patient," so Dr. Engel.
This is of particular significance when it comes to minimally invasive surgery, as it is the table's extreme tilting and tipping function that makes surgical interventions even possible on an obese patient.

With its unique height adjustment range varying between 535 mm (21 Inch) and 1235 mm (49 Inch), the MAGNUS ensures ergonomic and thus relaxed working conditions even during longer operations. The benefits of individual settings are particularly evident during laparoscopic interventions: As the MAGNUS can be lowered further than any other table the surgeon can keep his elbows positioned comfortably at his side and is not forced to revert to a tiring position. The table's unique lowering functionality makes the commonly used step stool to decrease the distance to the surgical field a thing of the past. The larger abdomens of obese patients can be operated on the MAGNUS while maintaining a relaxed and comfortable posture. In contrast to laparoscopic operations, a high table position is required for hip replacement in the dorsal position. This way, the operation which may take up to 90 minutes can be performed in an upright position. If the table cannot be adjusted to the height required, the surgeon is forced to assume a bent over posture which generally results in tension and fatigue.

Besides its settings designed to cater to various indications, the MAGNUS can optimally adjust to the height of the surgeon. The advantage of this comes to the fore when putting the table in an international context: Whereas the height of the average male in Sweden is 181.5 cm (71,4 Inch), the average male in the Philippines is less than 164 cm (64,5 Inch).

Press release (.pdf)...

MAGNUS : Product Features...

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Wednesday, April 29, 2009

New Brachytherapy Set for Better Dose Deliverance to Patients

Varian Medical Systems has introduced a new bronchoscopic brachytherapy applicator set, the Centering Intraluminal Applicator™, that the company says will increase treatment precision and aid comfort for patients suffering from bronchial cancer.

According to the press release, the new system features a novel catheter that enables a centered position of the source in the lumen of the trachea or the bronchus, all the while maintaining an open airway for better ventilation. This 3-centering catheter is designed such that it can be partially or fully extended, thus allowing for a variety of conformations to adapt to each patients unique anatomy.

"This new applicator set helps clinicians to optimize the dose distribution thanks to its ability to center the source at the middle of the bronchial lumen," says Claudia Andres-Zindler, brachytherapy applicator product manager. "Crucially, it also allows the patient to breathe unaided during treatment."

Features of the Centering Intralumninal Applicator™ include:

X-ray contrast strip to display the longitudinal axis and the spreading of the baskets.

Seldinger guide wire to insert and guide the centering catheter with the baskets into the desired position.

4.7 French catheter with a diameter of 1.59 mm for the source transfer.

Press release : Varian Introduces Brachytherapy Applicator Set to Optimize Precision and Comfort of Bronchial Cancer Treatments...

Varian Medical Systems - Brachytherapy...

Flashback : TargetScan Aims for Precise Brachytherapy

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Monday, April 27, 2009

TissuePatch Surgical Sealant Films

A company rep for British based Tissuemed Ltd. contacted Medgadget to let us know about the firm's product, a surgical sealant called TissuePatch, now on display at Hospitalar, the largest and leading medical trade fair in Latin America. The device, approved and distributed in the European Union, comes in two forms:

-- TissuePatch3, which is indicated for closure of air leaks after thoracic surgeries, as well as for " low pressure or oozing bleeding or fluid leakage following surgical procedures on soft tissue," and,

-- TissuePatchDural, which is indicated for use to "seal and reinforce against CSF leakage in neurosurgery."

Here's more about the product from the company:

More adherent than surgical glues, TissuePatch is easy to apply, requires no preparation and is effective within 30 seconds of contact. Most impressively the effective volume of foreign material used to achieve the desired surgical outcome is dramatically less than that required for equivalent coverage with any traditional liquid or fleece-type of product.
Its elasticity and conformability also means it works like a surgical ‘cling-film’ and has been optimised to address the very specific demands of different surgical environments and tissue types. It is also transparent to allow operators to visualise the underlying tissues. In fact, if it wasn’t for the logo printed within the multilaminate film, it would be almost invisible once in contact with the tissues.

Currently CE marked and being used in a variety of surgical applications this innovative device is ideal for sealing air leaks in lung surgery, cerebro-spinal fluid leaks in brain and spinal surgery and on a variety of organs in general surgery where blood and fluid leakage need to be prevented.

To learn more about the fused multilaminate technology behind this device, check out this .pdf file: TissuePatch3...

Product page: TissuePatch Surgical Sealant Films...

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Thursday, March 19, 2009

Cardinal's Endura Scrubs for the Modern Clinician

Cardinal Health is releasing a new line of clinical scrubs that the company believes will make your life safer, easier, and more comfortable. The big deal about Cardinal's Endura™ apparel line is the specialty fabric used, which is supposedly stronger and more breathable.

Some features from the product page:

Excess moisture is wicked away from your skin to keep you dry and cool, no matter what you’re doing.

Scrubs shouldn't leave you feeling restricted or confined. Endura™ scrubs move with your body and help maximize your gait and pace. In addition, the Maximum-Motion™ sleeve allows your shirt to stay tucked in even when you reach and stretch.

Our advanced, synthetic material is breathable, flexible and helps control your heat index and perspiration.

Our scrubs offer a shirt pocket and two side flanking pant pockets to tuck away the important things you want to keep close. The deep side pockets in our pants are angled to keep items in, whether you're sitting or standing.

The smooth fabric of Endura™ scrubs feels natural and soft on the skin.

People aren’t rectangular. So instead of making our scrubs rectangular, we looked at the actual dimensions of thousands of healthcare workers. The cut of our scrubs follows the natural line of your body and gets rid of the bulky feel and appearance of traditional scrubs.

A unique snap system allows you to customize pants length and avoid tripping, falling or slipping. Elastic on the waistband, in addition to a drawstring, helps position pants where you want them.

Strategically placed ventilation zones across the middle of the back and behind the knee keep you dry and comfortable.

Even after 90 washes, EnduraT scrubs are still going strong. Stronger than a brand-new pair of the top-selling traditional scrubs, in fact*. You'll also notice minimal color loss and lasting moisture-wicking abilities. The competitor's scrubs, on the other hand, typically only last 50 washes.

The top-selling traditional scrubs lose 15% lint when abraded. EnduraT scrubs lose only 1.4%, making them the lowest linting scrub on the market.

Made of the strongest material on the market, EnduraT scrubs outlast the competition. Our advanced, synthetic material is abrasion- and tear-resistant and has the most uniform strength in both directions.

EnduraT scrubs can be washed at cooler temperatures and dry faster than traditional scrubs. This requires less energy and can result in savings to your hospital.

Product page: Endura™ Performance Apparel

Press release: Cardinal Health launches new products for the operating room

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Monday, February 23, 2009

CT-guided Placement of Microcoils Helps with VATS for Lung Nodules

The Radiological Society of North America is reporting on new technology, developed at the University of British Columbia in Vancouver, that can guide the removal of small nodules within lungs. By preoperatively placing special fiber coated microcoils into the lung under CT guidance, a surgeon performing video-assisted thoracoscopic surgery (VATS) can remove a nodule with little damage to the surrounding tissue.

From the press release:

VATS is a minimally invasive technique in which one or more small incisions are made in the patient's chest and a small fiber optic camera and surgical instruments are inserted through the incisions. Images transmitted by the camera guide the physician through the procedure.
VATS can replace a traditional thoracotomy, a surgical procedure that uses one larger incision to gain access to the chest. VATS typically results in less pain and faster recovery time for the patient compared to open surgery.

Because small, peripheral lung nodules can be difficult to locate, physicians often have to resort to the more invasive thoracotomy procedure, removing larger amounts of lung tissue to successfully locate small nodules.

For the study, Dr. Mayo and colleagues used CT-guided microcoil placement to assist in VATS removal of 75 small, peripheral lung nodules in 69 patients ranging in age from 31 to 81 years. Four patients had two nodules treated, and two of the patients had second nodules removed at a later date. In all, 75 procedures were performed. The microcoil technique allowed the researchers to locate 100 percent of small nodules, and 97 percent of the lung nodules were successfully and completely removed with VATS.

The results show that with precise microcoil localization, even small nodules can be removed with VATS.

"The real beauty of this procedure is that we are able to remove the entire nodule and very little surrounding tissue, so there is no decrease in lung function," Dr. Mayo said. "Recovery time is significantly reduced in these patients as a result. Instead of the three- to six-week recovery period that follows a thoracotomy, these patients can return to work within two to three days."

Press release: Microcoils Help Locate Small Lung Nodules ...

Abstract: Lung Nodules: CT-guided Placement of Microcoils to Direct Video-assisted Thoracoscopic Surgical Resection Radiology 2009;250:576-585.

Image source: Wikipedia

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Friday, January 30, 2009

Endorsement Shines Bright Future for Single Port Laparoscopy

Cambridge Endo, a Massachusetts firm, is proud to have its single port laparoscopic technology selected by the Cleveland Clinic as one of the "game changing innovations" of 2009 at the clinic's Medical Innovation Summit. The Single-Site Surgery/Single Port Access system, driven by the company's proprietary Autonomy™ Laparo-Angle™ Instruments, allows for nearly scarless surgeries that patients are particularly excited about.

From Cambridge Endo's press release:

Inderbir S. Gill, M.D., Chairman of Urology at the Cleveland Clinic commented, "[we] performed LESS live-donor nephrectomies in nine consecutive kidney donors for kidney transplantation. All aspects of kidney harvesting were completed though the navel. Instead of a visible six-inch scar and a six-week recovery period, patients recovered within two weeks and had a tiny scar hidden by their belly button. Because it only uses one port with multiple channels for the surgeon to simultaneously pass various surgical instruments, LESS may also reduce complications that might occur after traditional open and even laparoscopic abdominal surgery. My patients report less discomfort and have faster recoveries compared to those undergoing traditional laparoscopy." According to the clinic, the return to work time for single port surgery donors is about 17 days vs. 51 for traditional multi-incision laparoscopic procedures.

Video of a single port simple nephrectomy:

Press release: Cleveland Clinic Selects Laparoendoscopic Single-Site Surgery (LESS) as One of the Top Ten Innovations of 2009

Product page: Single Port Access Surgery (SPA), Autonomy™ Laparo-Angle™ Instrumentation

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Monday, January 5, 2009

Amimon's High Definition Wireless Video Goes Clinical

Stryker Endoscopy is launching a wireless high definition monitor for the clinical world. Utilizing wireless technology from Israel's Amimon Inc., the monitor can receive signals up to 1080i, which means uncompromising quality in OR imaging with fewer tangled cables getting in the way.

AMIMON has granted Stryker Endoscopy exclusive access to AMIMON’s technology for the medical endoscopy market.
“Only AMIMON’s High-Definition Wireless Technology is capable of transmitting the surgical video with no perceptible lag or interference throughout the entire operating room. This will allow surgeons greater flexibility in positioning the surgical display while operating. In addition, the hospitals and surgery centers will save the hassle and cost of routing DVI cables through the ceilings and overhead booms,” said William Chang, Stryker Endoscopy’s Vice President of Research & Development and Chief Technology Officer.

AMIMON WHDI™ Technology - Overview ...

Press release: Stryker Endoscopy Launches the World's First High-Definition Wireless Surgical Display With AMIMON Inc.'s High-Definition Wireless Technology ...

Globes: Wireless video co Amimon wins deal with Stryker...

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Tuesday, December 30, 2008

Haemair Dreams of Prosthetic Mobile Lungs

Haemair Ltd., a Welsh company out of Swansea, has won this year's Stopford Projects Award for Bioprocess Innovation from the UK's Institution of Chemical Engineers. The company says that it is working on a compact prosthetic lung capable of doing the gas exchange for conscious and mobile patients. How different the device will be from the ECMO systems we have nowadays, we simply don't know. In addition to developing specialty hardware needed by the device, the company says the software is being built to automatically control the exchange rate and air pressure in the system to adjust for the changing metabolic needs of the subject. The company plans to begin clinical trials soon at Swansea University.

From Haemair's device page:

The unique feature of the Haemair approach is that it is aimed at conscious mobile patients. To this end, we match oxygen and carbon dioxide External Respiratory Device mass transfer rates to the respiratory demand of the patient. Furthermore, we employ a flow of natural air to provide oxygen and remove carbon dioxide.
There are three main variants of our device. The simplest to employ consists of a mass exchanger, as illustrated in figure 3. It takes deoxygenated blood, extracted from a main vein, removes carbon dioxide, replaces it with oxygen, and returns the oxygenated blood to the body. The second variant places the mass exchanger within the body to eliminate the hazard of taking a significant blood flow outside the body. The final version is a prosthetic lung, as illustrated in figure 2.

In all three variants, mass transfer is controlled so that performance mimics that of natural lungs. In this way, the natural respiratory control mechanism controls heart rate etc, and control is fully integrated with the natural respiratory system.

The external device will be deployed first. It is easily reversible and major parts are available for maintenance. The easy reversibility is important in treating emergency and acute cases for which the device might be needed for no more than hours or weeks. Once we have established that long maintenance-free operation is possible, we can move on to the intermediate device. The clinical procedure to “plumb” the device into the blood circulation system is more complex and maintenance is more difficult. However, the engineering is simpler. The only significant external item required is a small air pump, or fan. This device is more suited to patients who will need it for months – for example, as a bridge to transplant. It should enable patients to leave hospital and continue treatment at home. The final variant, a prosthetic lung, serves as an alternative to a lung transplant. This variant is illustrated in figure 3. It cannot be deployed until we have extensive favourable experience with the reversible devices. However, it offers hope to those currently excluded from transplant waiting lists – for example, most terminal emphysema sufferers.

Device page: Haemair Respiratory Aid and Prosthetic Lung ...

IChemE Awards 2008 page...

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Tuesday, December 16, 2008

Super Stethoscope from Deep Breeze Approved by FDA

We've been following the development of the VRIxp system from Deep Breeze Ltd out of Or-Akiva, Israel for the last three years. Now the company's flagship product for pulmonary audio analysis has received FDA approval, and the firm has teamed up with GE Healthcare to promote and distribute the device.

Here's basic info on how the VRIxp functions:

Two sensor array units (V-Array) are placed on a patient's back to collect the vibration response.

Airflow & turbulence in the large airways induce vibrations of the airway walls.

Proprietary algorithm combines the output signals, filter & process it to produce a sequence of images which reflect the vibration properties at each pixel position and at each interval.

These vibrations are affected by the property of the airways & by the lung tissue.

The VRIxp™ device passively records the vibration energy according to the vibration distribution.

The vibration energy is processed to produce a dynamic image of the lungs.

Product page: VRIxp...

Press release: GE HEALTHCARE ANNOUNCES FDA CLEARANCE AND US MARKET RELEASE OF AN INNOVATIVE, NON-INVASIVE & RADIATION-FREE LUNG IMAGING SYSTEM

Flashbacks: Vibration Response Imaging (VRI) Shows Promise In Assessing Postoperative Lung Function ; Video of VRIxp System from Deep Breeze ; New Pulmonary Imaging Modality Approved by the FDA ; The VRIxp System: New Noninvasive Way to Image Lungs

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Monday, November 24, 2008

Somatom Definition Flash: All Around Dual Nature CT

In about a week, at the upcoming 94th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Siemens will roll out the Somatom Definition Flash, a new dual source, dual detector CT scanner. The machine is so fast that patients don't have to hold their breath during chest scans, and the bed moves through the scanner at about twice the speed of conventional models, likely eliminating claustrophobia in most patients.

Some technical info about the scanner from Siemens' press release:

a man or a woman?

The fastest scanning speed in CT (43 cm/s) and a temporal resolution of 75 ms, enable for example complete scans of the entire chest region in just 0.6 seconds. Thus, patients are no longer required to hold their breath during the exam the way they had in the past. At the same time, the Somatom Definition Flash operates at an extremely reduced radiation dose. For example, a spiral heart scan can be performed with less than 1 millisievert (mSv), whereas the average effective dose required for this purpose usually ranges from 8 mSv to 40 mSv. The new CT scanner will be available for sale in the first quarter of 2009.

The gantry (i.e., the X-ray detector system surrounding the bore) rotates about its own axis in just 0.28 s. It is this extraordinary rotational speed that enables a scan speed never before attained in CT (i.e., up to 43 cm per second) and temporal resolution of 75 milliseconds. The patient is moved through the CT tube more than twice as fast as with any conventional system. At the same time, scans acquired with the Somatom Definition Flash require a much lower radiation dose than conventional scans. While the average effective dose for a heart CT scanner ranges from 8 mSv to 40 mSv, the new Siemens CT scanner gets by with less than 1 mSv. In comparison: The X-ray radiation that everyone is exposed to each year from natural sources amounts to 2 mSv to 5 mSv. The dose values of the new Siemens CT scanner, thus lie far below those of an intracardiac catheter examination, thus opening up possibilities for using CT scanners for routine cardiological examinations.

Due to the high scanning speed, it is now possible to acquire scans of the thorax, the heart or both at the same time in fractions of a second. For example, thorax examinations now only require a scan time of 0.6 seconds. As a result, patients no longer have to hold their breath during the scan. This offers considerable advantages, especially in cases involving the elderly, children, emergency, and ICU patients.

It is also possible to perform whole-body scans extremely fast: For example, a person with a height of 6 feet 6 inches can be scanned in less than 5 seconds. Until now, such whole-body examinations took more than 10 minutes to perform from patient preparation to diagnosis. With the Somatom Definition Flash, this process is completed in just a few minutes. This represents an advantage, especially for emergency medicine since, until now, physicians often had to forego this examination method due to time pressure. Furthermore, it is no longer necessary to sedate children prior to the examination, since they no longer have to remain still. The high scanning speed also makes it possible to cover large areas measuring up to 48 cm with 4D imaging (3D plus time). The areas scannable using conventional systems are limited to a maximum of 16 cm due to the detector size involved.

A scan of the entire heart can be performed in only 250 milliseconds, which is less than half a heart beat. In addition, it is possible for physicians to reliably display a heart with a fast pulse or an irregular heart beat without using beta blockers, thus simplifying the workflow and yielding clinical and financial advantages. Owing to its high scanning speed, the Somatom Definition Flash also features new possibilities for performing CT examinations of the heart in the sub-mSv range. This represents a much lower radiation dose than is obtainable with conventional systems, which require doses ranging from 8 mSv to more than 40 mSv. For the first time ever, the heart can thus be examined at a radiation exposure level that is three times lower than the background radiation a person naturally absorbs in a year.

The second generation of Dual Energy imaging will introduce a new imaging quality. The contrast in CT scans will be increased without having to apply the higher radiation dose previously required. This is achieved via a new, selective photon shield which blocks unnecessary parts of the energy spectrum. It thereby provides improved separation of the two simultaneous scans with low and high photon energy, without causing a higher radiation exposure than would result from an individual, conventional CT examination with only one energy source. Thus, the Somatom Definition Flash can always provide a double contrast which, for the first time ever, can also be used to classify the chemical composition of tissues via a CT scan in routine daily work. Subsequently, It could also be used to reconstruct unenhanced CT images without contrast media not having to perform an additional examination.

Gene Ostrovsky, one of our editors, joined Dr Val Jones of Better Health in a conversation with Dr. André Hartung of Siemens about the new machine. You can read the interview or listen to the podcast at Better Health...

Press release: Flash Speed. Lowest Dose (.pdf)...

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Friday, November 21, 2008

TruSystem 7500: New OR Table from TRUMPF

Thanks to its modular design, this new OR table from TRUMPF can accommodate almost all known surgical positions, and can provide an optimal operating environment for all kinds of cases, from hip pinnings to robotic prostatectomies.

In surgery, no operation is identical to another. So it's not just surgeons and staff who need to be flexible – that requirement applies to OR tables as well. For the TruSystem 7500 OR table system, TRUMPF offers universal OR tabletops with a variety of application options, and special OR tabletops for specific requirements. Depending on the desired application and budget, from an extensive product line users can put together the precise OR table that fits their individual needs.

TruSystem 7500 is consistently designed to simplify the everyday clinical work of physicians and staff, and to support them in their daily tasks. OR tabletops with up to three motorised joint pairs make it possible to use remote controls to position the patient quickly, safety and precisely. Manual adjustments to the tabletop are reduced. Staff can program the adjustment speed of all tabletop motors as needed. To return to the zero position, all motors in the tabletop work simultaneously, saving time.

A novel feature is the third motorised joint pair between the lower and upper back plates, which enables new positioning options. For thoracic surgeries, for instance, the patient's ribcage can be stretched precisely to the desired degree by pushing a button, so it can be opened more easily. Complicated positions, such as the side thorax position, can be assumed quickly, precisely and conveniently for both patient and staff. The patient also benefits from ergonomic, safe positioning, since the lengths of the individual tabletop segments correspond to the average distances between joints in the human anatomy.

TruSystem 7500 has universal coupling points, which have proven their worth in other TRUMPF OR tables. This latest OR table system is thus compatible with the entire TRUMPF accessory line, as well as with all other TRUMPF OR tables. The mechanically encoded coupling points prevent disallowed configurations of the table. Thus new and existing customers can quickly familiarise themselves with operation of the table. Moreover, they benefit from the option of combined use with predecessor models, and thus from the safety of investment in TRUMPF products. This philosophy permeates the entire TRUMPF medical technology portfolio.

One special feature of the “ST 26” special OR tabletop: First, the Trendelenburg capability is split between the column and the top. Besides the 45 degrees offered by the column, the tabletop can be adjusted by another 20 degrees. With the TruSystem 7500, therefore, an extremely low head or foot position of 65 degrees can be achieved. If the user doesn't need this additional functionality, less expensive universal OR tabletops can be selected.

Special TRUMPF positioning accessories can be mounted on the TruSystem 7500 tabletops at any time. A spinal column positioning assembly, an extension unit or carbon elements for intraoperative X-ray diagnosis, for instance, make this jack-of-all-trades a specialist in just moments.

Check out all the available positions and accessories in this product brochure...

Product page: TruSystem 7500...

Press release...

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Wednesday, October 29, 2008

PlasmaBlade Finds New Uses With New Attachments

PEAK Surgical, maker of the innovative PlasmaBlade replacement of the bovie, has put a couple extensions for its device onto the market.

The PlasmaBlade Needle, which has a fine needlepoint tip, is specifically designed for ultra-precise surgical procedures. The PlasmaBlade EXT is designed for use in surgical procedures requiring an extended-reach tip.
In July, the U.S. Food and Drug Administration granted PEAK Surgical 510(k) clearance to market the PEAK® Surgery System, including the PlasmaBlade 4.0, for use in general surgery. The PlasmaBlade 4.0 is designed to be used to cut through all types of soft tissue, including skin, fat and muscle. All of the PlasmaBlade tissue dissection tools are used in conjunction with PEAK's PULSAR™Generator, which provides pulsed plasma radiofrequency energy to the PlasmaBlade to create surgical incisions and control bleeding. They offer the exacting control of a scalpel and the coagulation of traditional electrosurgery without extensive collateral damage.

Press release: PEAK Surgical Introduces PlasmaBladeTM Product Line Extensions for Use in General Surgery

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

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