Thursday, November 5, 2009
FDA Panel Recommends Bronchial Thermoplasty Approval for Select Patients
According to Dow Jones Newswires, an FDA panel has recommended the approval of Alair® bronchial thermoplasty device from Sunnyvale, California based Asthmatx, Inc. Designed to reduce the amount of smooth muscles in the walls of small to medium size airways, the device will likely be indicated for drug-resistant adult cases of severe asthma. We have reported extensively on this technology, including on positive results from the Asthma Intervention Research 2 (AIR2) Trial, a 300 patient strong study reported in May, that has showed reduction in extreme asthma attacks by 32 percent, and 84 percent reduction in emergency room trips in patients s/p treatment.
The device--the Alair Bronchial Thermoplasty System--if approved would be the first non-drug treatment approved by the FDA. The product is made by Asthmatx Inc., a closely held firm based in Sunnyvale, Calif., and is designed to be used in adult asthma patients whose disease isn't well controlled on both short- and long-acting medications.Specifically, the panel voted 6 to 1 that the treatment be approved with conditions, including a registry of patients treated to track the long-term safety and effectiveness of the device. The FDA typically follows the advice of its panels but isn't required to. If approved, the device could be on the market during the first half of 2010.
The FDA noted that about 22 million Americans have asthma and about 4,000 people die each year "in spite of optimal medical management." About 500,000 people are hospitalized with asthma exacerbations annually in the U.S.
Dow Jones Newswires: FDA Panel Backs Novel Device To Treat Severe Asthma...
Technology page: Bronchial Thermoplasty...
Flashbacks: Bronchial Thermoplasty Does Well in AIR2 Trial ; The Alair® System for Bronchial Thermoplasty™; Alair System May Become Option for Asthmatics
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Monday, October 26, 2009
TRUMF's OR Table Integrated With Siemens Multi-axis Fluoroscopy Systems
Siemens has just announced that it has integrated the TruSystem 7500 OR table from TRUMPF (Puchheim, Germany) with its Artis zee and Artis zeego fluoroscopy scanners. The TruSystem 7500 adjusts to just about any position imaginable and is transparent to x-rays, and so can be used in almost any surgical or invasive radiological procedure. TruSystem 7500 OR table is illustrated above, and Artis zeego multi-axis interventional fluoroscope is shown in the picture below.
The Trumpf OR table has been designed especially for this integration and is equipped with a onepiece carbon tabletop, which can be replaced by a segmented universal tabletop. The table column enables the two tops to be exchanged easily. The carbon tabletop is transparent to X-rays and thus ensures that there will be no disruptive artifacts in the images. It is suitable for interventional procedures and minimally invasive surgery. The integration of the OR table with the Siemens angiography systems also make fast rotations and 3-D imaging possible with the surgical C-arm. The modular design of the segmented tabletop enables extremely flexible positioning of the patient, particularly important in orthopedics and neuro surgery. Complicated positions, such as the chest side position, can be achieved quickly with great precision as well as comfort for the patient and staff.
Along with the integrated Trumpf OR table, Siemens continues to offer its Artis tables for the entire Artis zee series, which are available in three designs: as a standard table, a table with Trendelenburg tilting and one with Trendelenburg and lateral tilting.
Press release: Siemens integrates Trumpf's OR table in its Artis zeego and Artis zee ceiling angiography systems...
Product pages: TruSystem 7500, Artis zee, Artis zeego
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Wednesday, October 21, 2009
ThumBlade Scalpel Safety System
Here's an interesting new take on improving the safety for scrub techs, nurses and surgeons. ThumBlade™ scalpel system from Precision Medical Devices Inc. (Marlboro, NJ) is a no contact, disposable safety sheath that covers blades, and allows activation of the scalpel with just one hand. So no more sharps and no more mosquito use to mount a blade.
Medgadget has obtained the following details about the device:
Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.
Product page: ThumBlade™ safety scalpel system...
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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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Thursday, October 1, 2009
A-lap Is an Innovative Laparoscopic Surgical Retractor
Israeli business newspaper Globes reports that EZ Surgical out of Yoqneam, Israel has signed a distribution deal with Medline Industries out of Mundelein, Illinois to sell some of the firm's products in the United States. One of the devices from EZ Surgical that got us interested, since we have not seen something like this before, is the A-lap retractor for pushing away organs during laparoscopic surgeries.
A-Lap™ is a pure 5mm laparoscopic innovation and first of its kind 3D retractor/displacement device. A-Lap™ comes packaged with a dedicated soft flexible port, or may be deployed through an existing skin incision. Features include an atraumatic mesh controlled by an intuitive handle design allowing the user to manipulate and lock-in the degree to which the device is opened. This accommodates for multiple applications, including intra-abdominal retraction, liver retraction, lung retraction and anyplace where atraumatic tissue or organ displacement is required. When opened, there is no volume loss as compared to traditional laparoscopic retractors, or “fan” technology and is not limited by their associated single plane retraction.
Check out this video to understand how useful this device can really be:
Product page: The A-Lap...
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Monday, September 21, 2009
New Surgical Glue from Lifebond to Offer a Stronger, Tighter Seal
Lifebond out of Caesarea Industrial Park, Israel has developed a new surgical sealant which is apparently stronger than the currently used blood-derived fibrin glues. The LifeSeal SLR staple line reinforcement sealant and LifeSeal Surgery sealant 
for general surgery are two main products from the company that are based on its proprietary hydrogel matrix technology, in which individual protein molecules tend to cross-link and form fibrin-like networks. The company plans to ask for US and European approval to market the material next year.
LifeBond's technology functions through the rapid and biocompatible in situ cross-linking of structural proteins. As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix. The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.LifeSeal GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.
Application of LifeSeal GI onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GI seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.
LifeSeal Surgical sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.
Links: Lifebond technology page; LifeSeal SLR; LifeSeal Surgery
(hat tip: ISRAEL21c)
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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
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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:
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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."
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:
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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 ...
More from Mass High Tech...
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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).
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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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