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<title>Medgadget</title>
<link>http://www.medgadget.com/</link>
<description>Internet journal of emerging medical technologies.</description>
<copyright>Copyright 2008</copyright>
<lastBuildDate>Tue, 01 Jul 2008 00:00:03 -0800</lastBuildDate>
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<item>
<title>Bandages Electrocute Infections Away</title>
<description><![CDATA[<p><img class="bcntr" src="http://www.medgadget.com/archives/img/electricbandage.jpg" width="468" height="249" /><br />
<strong>Silverleaf Medical Products</strong> Inc., out of Tempe, Arizona, manufactures electrically activated wound dressings.  The firm's proprietary material allows electric current to flow through the wet parts of the fabric.</p>

<p>From the product page:</p>

<blockquote>CMB&trade; Antimicrobial Wound Dressing with PROSIT&trade;   is a single layer dressing consisting of a polyester fabric layer containing biocompatible, proprietary formulas which are held in position on the polyester with a biocompatible binder.  The polyester fabric is single ply and is made from multi-filament spun threads woven together.

<p>PROSIT&trade; activates and generates a voltage at the surface when moistened. When active, PROSIT&trade; prevents microbial penetration. Present device can be left on for 3 days. Other indications are currently being applied for. </blockquote></p>

<p><strong>Product page:</strong> <a href="http://smp-prosit.com/products.htm" title="CMB™ Antimicrobial Wound Dressing with PROSIT™">CMB&trade; Antimicrobial Wound Dressing with PROSIT&trade; ...</a></p>

<p><i>Phoenix Business Journal</i> report about the company's <a href="http://www.bizjournals.com/phoenix/stories/2008/06/23/story1.html">recent news</a> of extending FDA indications for the product at ...</p>]]></description>
<link>http://www.medgadget.com/archives/2008/07/bandages_electrocute_infections_away.html</link>
<guid>http://www.medgadget.com/archives/2008/07/bandages_electrocute_infections_away.html</guid>
<category>Surgery</category>
<pubDate>Tue, 01 Jul 2008 00:00:03 -0800</pubDate>
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<item>
<title>DermaStream Chronic Wound Treatment Technology</title>
<description><![CDATA[<p><img alt="" class="cntr" src="http://www.medgadget.com/archives/img/46534tro.jpg" width="457" height="320" /><br />
Over at Israel's newspaper <em>Globes</em> <a href="http://www.globes.co.il/serveen/globes/DocView.asp?did=1000348268">we read</a> about a start-up <strong>EnzzySurge</strong> Ltd., a company working on novel chronic wound treatment technology. According to the newspaper, "EnzySurge is now completing the effectiveness clinical trial of its product in Israel, which shows that the product produces a significant improvement in wounds. The believes that it has a strong likelihood of obtaining US Food and Drug Administration (FDA) approval for its product as a "combined product" without the need for additional clinical trials. The FDA has already approved a device that EnzySurge has developed but not the combined product with chemical solution."</p>

<p>Indeed, according to this <a href="http://www.fda.gov/cdrh/pdf6/K060046.pdf">FDA 501(k) summary (.pdf)</a>, the device has been cleared by the FDA in 2006, but it is still pending European CE Mark of approval.</p>

<p>More about the EnzySurge technology, as it is presented by the company:</p>

<blockquote>DermaStream is a multi-patented, multi-disciplinary treatment for chronic wound care. Developed by a combined team of bio-technology, medical device and wound care specialists, DermaStream combines a unique device with bio-active formulae to rapidly and painlessly treat and control the wound environment. With CST&trade; (Continuous Stream Therapy) technology at its core, it streams an ongoing supply of fresh, bio-active solution to trigger the desired reaction while actively and selectively draining, suctioning and washing away bacteria, necrotic tissue and other undesirable exudates...

<p>The easy-to-use DermaStream&trade; device designed for hospital and home treatment continuously streams fresh doses of highly active solutions into the controlled wound environment. DermaStream actively drains, dissolves and washes away bacteria, necrotic tissue and other undesirable exudates.</p>

<p>DermaStream&trade; device features:<br />
Three innovative actions operate in refined concert to expedite treatment of chronic wounds with unprecedented efficacy, safety and patient comfort:</p>

<p>1. Continuous streaming of fresh solution<br />
This unique irrigation system ensures uniform flow of highly active ingredients over the entire wound surface and a continuously moist wound environment.</p>

<p>2. Ongoing removal of bacteria, necrotic tissue &amp; excess exudates<br />
An innovative combination of three cleansing actions uniquely responsive to the controlled wound environment:</p>

<blockquote><li>Continuous drainage of excess exudates</li>
<li>Mild negative pressure achieves faster, proactive removal of necrotic burden in addition to enhanced active ingredient's efficacy and tissue regeneration</li>
<li>Hypertonic medium for biochemical extraction of excess fluid</li></blockquote>

<p>3. Controlled wound environment</p>

<p>The durable yet flexible, water-tight protective streaming device minimizes wound exposure to damaging elements while providing a controlled, moist environment for optimal receptiveness to active ingredients.</p>

<p>The versatile DermaStream device is available with highly active yet safe solutions specially developed for the debridement, regeneration and closure phases of wound &lrm;management.</blockquote></p>

<p><strong>Product page:</strong> <a href="http://www.enzysurge.com/Temp/default.asp?PageID=8" title="DermaStream">DermaStream...</a></p>

<p><strong>Globes:</strong> <a href="http://www.globes.co.il/serveen/globes/DocView.asp?did=1000348268" title="Wound treatment co EnzySurge raises $4m">Wound treatment co EnzySurge raises $4m...</a></p>]]></description>
<link>http://www.medgadget.com/archives/2008/06/dermastream_chronic_wound_treatment_technology.html</link>
<guid>http://www.medgadget.com/archives/2008/06/dermastream_chronic_wound_treatment_technology.html</guid>
<category>Surgery</category>
<pubDate>Tue, 03 Jun 2008 00:00:02 -0800</pubDate>
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<item>
<title>Scientists Tout Wound Dressing Based on Silica Gel Fibers</title>
<description><![CDATA[<p><img alt="" class="bside" src="http://www.medgadget.com/archives/img/46534wo.jpg" width="300" height="284" />Investigators at the Fraunhofer Institute for Silicate Research ISC in W&uuml;rzburg, Germany believe that a new material, based on silica gel fibers, can offer therapeutic advantages for treatments of a variety of skin wounds, particularly for patients with decubitus ulcers, diabetic skin breakdowns, or burns:</p>

<blockquote>The wounds can be treated with conventional collagen dressings or polylactic acid dressings, but the success rate is not as good as it should be. A new type of dressing made of silica gel fibers, developed by scientists at the Fraunhofer Institute for Silicate Research ISC in W&uuml;rzburg, shall solve the problem. This novel dressing has many advantages: it is shape-stable, pH-neutral and 100 percent bioresorbable. Once applied it remains in the body, where it gradually degrades without leaving any residues. What&rsquo;s more, the fibre fleece provides the healthy cells around the edges of the wound with the structure they additionally need for a proper supply of growth-supporting nutrients. To prevent any infection, treatment of the wound must be absolutely sterile. &ldquo;As only the outer bandage needs to be changed, the risk of contaminating the wound is low,&rdquo; explains Dr. J&ouml;rn Probst of the ISC. And thanks to the supporting matrix for the cells, the chances of a scar-free natural closure of the wound are very good.

<p>The fibers are produced by means of wet-chemical material synthesis, a sol-gel process in which a transparent, honey-like gel is produced from tetraethoxysilane (TEOS), ethanol and water in a multi-stage, acidically catalyzed synthesis process. The gel is processed in a spinning tower: &ldquo;We press it through fine nozzles at constant temperatures and humidity levels,&rdquo; explains Walther Glaubitt, the inventor of the silica gel fibers. &ldquo;This produces fine endless threads which are collected on a traversing table and spun in a specific pattern to produce a roughly A4-sized multi-layer textile web.&rdquo; The dressings are then cut, packed and sterilized. Dr. J&ouml;rn Probst and Dipl.-Ing. Walther Glaubitt will receive the Joseph von Fraunhofer Prize 2008 for developing the biocompatible dressing.</p>

<p>A partner to support the development and market the dressing has already been found: Bayer Innovation GmbH BIG, a wholly owned subsidiary of Bayer AG. &ldquo;We anticipate that hospitals will start to use the silica gel wound dressing in 2011,&rdquo; states Iwer Baecker, project manager at Bayer Innovation GmbH.</blockquote></p>

<p><strong>Full story:</strong> <a href="http://www.fraunhofer.de/EN/press/pi/2008/05/ResearchNews5s2008Topic3.jsp" title="Rapid wound healing">Rapid wound healing...</a></p>]]></description>
<link>http://www.medgadget.com/archives/2008/05/scientists_tout_wound_dressing_based_on_silica_gel_fibers.html</link>
<guid>http://www.medgadget.com/archives/2008/05/scientists_tout_wound_dressing_based_on_silica_gel_fibers.html</guid>
<category>Surgery</category>
<pubDate>Wed, 28 May 2008 10:58:36 -0800</pubDate>
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<item>
<title>Polyheal&apos;s Microsphere-Based Wound Healing Technology</title>
<description><![CDATA[<p><img alt="" class="bside" src="http://www.medgadget.com/archives/img/5343pl1.jpg" width="187" height="175" />Israel's business newspaper <em>Globes</em> is <a href="http://www.globes.co.il/serveen/globes/DocView.asp?did=1000342766">reporting</a> that medical device company <em>Polyheal</em> Ltd. has "reported satisfactory results in its first clinical trial. The company tested its sterile disposable suspension on 20 patients and successfully treated chronic wounds that did not respond to other products. It is currently conducting an evaluation trial to compare its technology with the best treatments currently available, with the aim of highlighting the advantages of its own product."</p>

<p>The company's wound treatment product Polyheal 1&reg; is based on a proprietary chemically inert non-biodegradable microspheres, that are thought to promote wound healing. How they do that, no one seems to know for sure. The running theory is that the microspheres provide additional surface area for cell attachment. And this results in "a cascade of cellular events including changes in cell membrane, cytoskeletons, cytokines and altered gene regulation," according to researchers at Rabin Medical Center.</p>

<p><img alt="" class="bside" src="http://www.medgadget.com/archives/img/5343pl2.jpg" width="188" height="176" />Here's what the company says about its product:</p>

<blockquote>Polyheal's wound healing technology is based on the concept of triggering the patient's own cells to regenerate the deteriorated tissue of chronic wounds. This process of tissue repair is the core of Polyheal's wound healing technology. The specially designed physical-chemical features of the microspheres were designed to optimize the therapeutic process.

<p>The proprietary tissue repair technology is based on the use of non-biodegradable, chemically inert synthetic charged microspheres, characterized by their narrow size distribution.</p>

<p>The Company's first product, consists of  a water based suspension of microspheres, which can be easily applied onto the acute or chronic wound by direct wetting or by spraying. Polyheal's findings show that its charged microspheres have a therapeutic effect on wound healing, by their activation of different types of cells in the wound space (inflammatory cells, fibroblasts and keratinocytes).</p>

<p>The company's advanced chronic wound care and tissue repair product has been successfully tested in clinical trials for promoting the initiation of granulation tissue growth and remodeling of damaged skin tissue, when applied to the wound surface.</p>

<p>Our primary focus is clinical availability of advanced tissue repair treatments that bring improvements to health and quality of life for chronic wounds patients worldwide.</p>

<p>Polyheal collaborates with wound care specialists to develop innovative wound healing products with state-of-the-art clinical evidence and to support chronic wound patients with professional treatment guidelines.</blockquote></p>

<p><strong>Product page:</strong> <a href="http://www.polyheal.co.il/?categoryId=17677" title="The Advanced Microsphere-Based Wound Healing Technology">The Advanced Microsphere-Based Wound Healing Technology...</a></p>]]></description>
<link>http://www.medgadget.com/archives/2008/05/polyheals_microspherebased_wound_healing_technology.html</link>
<guid>http://www.medgadget.com/archives/2008/05/polyheals_microspherebased_wound_healing_technology.html</guid>
<category>Surgery</category>
<pubDate>Fri, 23 May 2008 09:40:57 -0800</pubDate>
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<item>
<title>Wallet-Size Mulitspectral Imaging System for Skin Diagnostics</title>
<description><![CDATA[<p><img alt="" class="bside" src="http://www.medgadget.com/archives/img/5645tvp1.jpg" width="300" height="242" />Georgia Tech is reporting that its scientists at the university's Center for Assistive Technology and Environmental Access (CATEA) developed a handheld low-cost technology to scan any surface for abnormalities. The investigators were actually working on a system that can empower "front line clinicians with no specialized training to detect and assess, in real-time, the severity of bruises and erythema, regardless of patient skin pigmentation or available lighting." Now the hope is that such a system can be used for detection and characterization of such things as melanoma, other forms of skin CA, or decubitus ulcers.</p>

<p>More about technology:</p>

<p><img alt="" class="bside" src="http://www.medgadget.com/archives/img/5645tvp2.jpg" width="300" height="210" /><blockquote>Researchers at Georgia Tech have developed a narrowband filter mosaic that will expand the uses and functionality of multispectral imaging&mdash;a technology that enables subsurface characterization...</p>

<p>In addition to this application, the filter could potentially offer a reliabile, low-cost method to instantaneously classify military targets, sort produce, inspect product quality in manufacturing, detect contamination in foods, perform remote sensing in mining, monitor atmospheric composition in environmental engineering and diagnose early stage cancer and tumors.</p>

<p>The technology was developed in Georgia Tech&rsquo;s Center for Assistive Technology and Environmental Access (CATEA) as part of a project to design a portable erythema and bruise-detection technology that will enhance early prevention and diagnosis of pressure ulcers, a secondary complication for people with impaired mobility and sensation.</p>

<p>Currently, clinical assessment of bruises is subjective and unreliable, especially when on persons with darkly pigmented skin. Improved imaging can lead to earlier intervention which is vital in cases of suspected physical abuse. Similarly, early detection of erythema can trigger preventive care that can stop progression into pressure ulcers.</p>

<p>Pressure ulcers are a serious secondary complication for people with impaired mobility and sensation. Annual Medicare spending is conservatively approximated at $1.34 billion for the treatment of pressure ulcers. Early detection of erythema can prevent progression into more serious Stage III or Stage IV pressure ulcers.</p>

<p>The filter mosaic can be conveniently laminated with imaging sensors used in digital cameras. With a patent pending, CATEA researchers are currently seeking collaborative or financial support to further develop and design the device.</p>

<p>&ldquo;Although multispectral imaging has matured into a technology with applications in many fields, clinicians and practitioners in these fields have generally stayed away from it due to extremely high costs and lack of portability,&rdquo; said Dr. Stephen Sprigle, director of CATEA and professor of industrial design and human physiology. &ldquo;Now, the possibilities are plentiful.&rdquo;</blockquote></p>

<p><strong>Press release:</strong> <a href="http://www.gatech.edu/newsroom/release.html?id=1886" title="GT | New Technology Puts Biomedical Imaging in Palm of Hands">New Technology Puts Biomedical Imaging in Palm of Hands...</a></p>]]></description>
<link>http://www.medgadget.com/archives/2008/05/walletsize_mulitspectral_imaging_system_for_skin_diagnostics.html</link>
<guid>http://www.medgadget.com/archives/2008/05/walletsize_mulitspectral_imaging_system_for_skin_diagnostics.html</guid>
<category>Dermatology</category>
<pubDate>Tue, 20 May 2008 10:45:45 -0800</pubDate>
</item>
<item>
<title>Peak PlasmaBlade Wants to Be The New Bovie</title>
<description><![CDATA[<p><img alt="" class="bcntr" src="http://www.medgadget.com/archives/img/3533pl1.jpg" width="468" height="193" /><br />
<strong>PEAK Surgical</strong>, Inc. from Palo Alto, CA hates the bovie cutter/coagulator. The company cannot stand the 1920's technology behind the bovie, and how its thermal function destroys healthy patient tissue around the cut. What do we hate about the bovie? Well, you know: all those bovie induced burns and destroyed gloves that surgeons are regularly subjected to.</p>

<p>Long story short, PEAK Surgical wants its Peak PlasmaBlade, a cold cutter and coagulator, to be the bovie of the 21st century. The company is quite hopeful: a new study presented in a poster session at the ongoing American College of Obstetricians and Gynecologists' (ACOG) 56th Annual Clinical Meeting in New Orleans showed that PEAK PlasmaBlade&trade; "cut freshly excised human abdominal tissue with little thermal tissue injury compared with traditional electrosurgery."</p>

<p>More about the technology:</p>

<blockquote>Electrosurgery was invented in the beginning of the 20th century and became one of the most-often used surgical tools after William Bovie introduced his electrosurgery (radiofrequency) generator in 1926. Since then, electrosurgical cutting has been performed using continuous radiofrequency waveforms, which thermally vaporizes soft tissue via an electrical arc through air and Joule heating. This results in a cutting and coagulation action that leaves a wide zone of collateral thermal damage.

<p>By contrast, PEAK Surgical&rsquo;s PULSAR Generator supplies pulsed waveforms that produce short plasma-mediated, highly controlled electrical discharges through extensively insulated electrodes on a handheld device -- the PEAK PlasmaBlade. Because the radiofrequency is provided in short pulses with low duty cycle (fraction of time the voltage is ON), and the PEAK PlasmaBlade is so highly insulated, heat diffusion and associated thermal damage to surrounding tissues is limited, resulting in greatly reduced collateral damage and extreme cutting precision.</p>

<p>PEAK Surgical&rsquo;s technology including the pulsed plasma-mediated discharges and electrode insulation techniques were originally developed by Professor Daniel Palanker&rsquo;s group at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University. They have been evaluated in ophthalmic applications, including human studies in retinal and cataract surgery &ndash; one of the most delicate, precise and difficult types of surgery, and in preclinical studies.</blockquote></p>

<p>Check out the following product brochure distributed by PEAK Surgical:</p>

<center><object codebase="http://download.macromedia.com/pub/shockwave/cabs/flash/swflash.cab#version=9,0,0,0" id="-698214008" name="-698214008" classid="clsid:d27cdb6e-ae6d-11cf-96b8-444553540000" align="middle" height="500" width="468"> <param name="movie" value="http://documents.scribd.com/ScribdViewer.swf?document_id=2903542&access_key=key-2m5fsf4xacl9dwdssmdg&page=1&version=1"> <param name="quality" value="high"> <param name="play" value="true"> <param name="loop" value="true"> <param name="scale" value="showall"> <param name="wmode" value="opaque"> <param name="devicefont" value="false"> <param name="bgcolor" value="#ffffff"> <param name="menu" value="true"> <param name="allowFullScreen" value="true"> <param name="allowScriptAccess" value="always"> <param name="salign" value=""> <embed src="http://documents.scribd.com/ScribdViewer.swf?document_id=2903542&access_key=key-2m5fsf4xacl9dwdssmdg&page=1&version=1" quality="high" pluginspage="http://www.macromedia.com/go/getflashplayer" play="true" loop="true" scale="showall" wmode="opaque" devicefont="false" bgcolor="#ffffff" name="-698214008_object" menu="true" allowfullscreen="true" allowscriptaccess="always" salign="" type="application/x-shockwave-flash" align="middle" height="500" width="468"></embed> </object><div style="font-size:10px;text-align:center;width:468"><a href="http://www.scribd.com/doc/2903542/PeakBrochure">PeakBrochure</a> - <a href="http://www.scribd.com/upload">Upload a doc</a></div><div style="display:none"> Read this doc on Scribd: <a href="http://www.scribd.com/doc/2903542/PeakBrochure">PeakBrochure</a> </div> </center>

<p><strong>Product page:</strong> <a href="http://peak.odacms.com/products/plasmablades/">Peak PlasmaBlade</a>...</p>

<p><strong>Press release:</strong> <a href="http://peak.odacms.com/news/press-releases/index.cfm?i=135">PEAK Surgical Announces Positive Results from Preclinical Study of PEAK PlasmaBlade&trade; for Obstetric and Gynecologic Surgery</a></p>

<p><a href="http://peak.odacms.com/video/plasmablade.cfm">Video demonstrating the device</a>...</p>]]></description>
<link>http://www.medgadget.com/archives/2008/05/peak_plasmablade.html</link>
<guid>http://www.medgadget.com/archives/2008/05/peak_plasmablade.html</guid>
<category>Surgery</category>
<pubDate>Wed, 07 May 2008 10:07:53 -0800</pubDate>
</item>
<item>
<title>Syneron&apos;s LipoLite Receives FDA Clearance</title>
<description><![CDATA[<p><img class="side" src="http://www.medgadget.com/archives/img/LipoLite-system.jpg" width="169" height="333" /><strong>Syneron Medical</strong>, a company from Israel, just received approval from the FDA to market their new minimally invasive laser-assisted lypolysis machine, in which laser heats, destroys, and coagulates subdermal tissue.</p>

<p>From the press release:</p>

<blockquote>For patients, LipoLite is both a minimally invasive alternative and a complement to traditional liposuction fat-removing procedures. The procedure requires only local anesthetic and is designed to provide patients lasting results with little downtime and a high level of safety. For physicians, the small, compact LipoLite system is comfortable to use, upgradeable to support future applications and fits easily on tabletops to save floor space in small operating rooms where space can be at a premium.</blockquote>

<p>From the product page:</p>

<blockquote>LipoLite causes fat cells to break apart and be eliminated by the body through non-selective heating of the adipose tissue. The 1064nm Nd:YAG laser energy is delivered via an optical fiber inside a cannula, inserted through a tiny incision to the treatment site.

<p><img class="side" src="http://www.medgadget.com/archives/img/lipolite_clinical_illustration.gif" width="175" height="168" />The thermal energy has the added advantage of tissue tightening via simultaneous photo-stimulation of dermal collagen.</p>

<p>Due to the coagulation properties of Nd:YAG lasers, there is less bruising or bleeding as compared to traditional liposuction for faster recovery.</p>

<p>As a complementary procedure to traditional liposuction, laser assisted lipolyis with LipoLite can treat smaller areas not possible with liposuction.</blockquote></p>

<p><strong>Product page:</strong> <a href="http://www.syneron.com/Solutions/Physicians/Products/lipolite.html" title="LipoLite">LipoLite...</a></p>

<p><strong>Press release:</strong> <a href="http://www.easyir.com/easyir/prssrel.do?easyirid=256C4E86057F2703&version=live&prid=391952&releasejsp=release_43">Syneron's LipoLite(TM) Minimally Invasive Laser-Assisted Lypolysis Receives FDA Clearance</a>.</p>]]></description>
<link>http://www.medgadget.com/archives/2008/05/synorons_lipolite.html</link>
<guid>http://www.medgadget.com/archives/2008/05/synorons_lipolite.html</guid>
<category>Plastic Surgery</category>
<pubDate>Mon, 05 May 2008 00:00:30 -0800</pubDate>
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<item>
<title>FDA Approves ARTISS Slow-Setting Fibrin Sealant for Treatment of Burn Patients</title>
<description><![CDATA[<p><img alt="" class="bside" src="http://www.medgadget.com/archives/img/4354fib.jpg" width="300" height="148" />ARTISS fibrin sealant, a newly approved Baxter company product, is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns, for both adults and pedi patients. It is not indicated for hemostasis.</p>

<p>The following is from the statement by the FDA:</p>

<blockquote>Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. Artiss (Fibrin Sealant, VH S/D 4) differs from other fibrin sealants in that it contains a lower concentration of thrombin. This lower concentration allows surgeons more time to position skin grafts over burns before the graft begins to adhere to the skin. Artiss also contains aprotinin, a synthetic protein that delays the break down of blood clots.

<p>"The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites," said Jesse L. Goodman M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "The approval also provides an additional choice for health care professionals in providing burn treatment."</p>

<p>The fibrinogen and thrombin proteins in Artiss are derived from human plasma, collected from FDA-licensed plasma centers. Both proteins undergo purification and virus inactivation treatments to reduce the risk of blood-transmissible infections. </p>

<p>During a multicenter clinical trial, investigators evaluated Artiss for its ability to attach skin grafts on two wound sites for 138 patients. At one test site, the skin graft was fixed with Artiss; at the other test site, the graft was fixed with surgical staples. The results showed that Artiss was, within a statistical error, as good as staples to attain complete wound closure. </blockquote></p>

<p><strong>Press releases:</strong> <a href="http://www.fda.gov/bbs/topics/NEWS/2008/NEW01807.html" title="FDA Approves New Medical Adhesive to Treat Burn Patients">FDA Approves New Medical Adhesive to Treat Burn Patients...</a>; <a href="http://www.baxter.com/about_baxter/news_room/news_releases/2008/03-20-08-artiss.html" title="Baxter Announces FDA Approval of ARTISS Slow-Setting Fibrin Sealant in Treatment of Burn Patients">Baxter Announces FDA Approval of ARTISS Slow-Setting Fibrin Sealant in Treatment of Burn Patients...</a></p>

<p><a href="http://www.baxter.com/products/downloads/ARTISS_PI.pdf">Prescribing info (.pdf)...</a></p>]]></description>
<link>http://www.medgadget.com/archives/2008/03/fda_approves_artiss_slowsetting_fibrin_sealant_for_treatment_of_burn_patients.html</link>
<guid>http://www.medgadget.com/archives/2008/03/fda_approves_artiss_slowsetting_fibrin_sealant_for_treatment_of_burn_patients.html</guid>
<category>Surgery</category>
<pubDate>Tue, 25 Mar 2008 00:00:01 -0800</pubDate>
</item>
<item>
<title>Silk&apos;n Hair Removal System FDA Approved</title>
<description><![CDATA[<p><img class="side" src="http://www.medgadget.com/archives/img/hairremoval.jpg" width="300" height="357" />Israeli company <strong>Home Skinovations</strong> Ltd. has received FDA approval to market its Silk'n hair removal system, a device that works via company's proprietary light therapy, dubbed Home Pulsed Light&trade; (HPL&trade;).   Designed to be used by the patient, but with physician guidance, the system promises both efficacy and privacy.</p>

<blockquote>The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.

<p>The efficacy and safety of Silk&rsquo;n&trade; was tested in a multi-center clinical study involving 4 medical centers in North America and Israel over the last 12 months. A total of 150 patients self treated with Silk&rsquo;n&trade; in physicians&rsquo; offices as part of the study, and the initial hair count as well as the post-treatment hair count of these patients was monitored by the investigating physicians.</p>

<p><img alt="" class="bside" src="http://www.medgadget.com/archives/img/67876tr.jpg" width="260" height="128" />An average reduction of 50% in the hair count was monitored three months post three bi-weekly treatment sessions. No adverse effects were noted in the course of the study, and the users of Silk&rsquo;n&trade; recorded an extremely high level of satisfaction with the device and their results. </blockquote></p>

<p><b>Press release</b>: <a href="http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&amp;newsId=20080324005462&amp;newsLang=en">Silk'n&trade; Personal Light-Based Hair Removal Device Cleared by FDA</a></p>

<p><strong>Product page</strong>: <a href="http://www.silkn.com/home_pulsed_light">Silk'n</a></p>]]></description>
<link>http://www.medgadget.com/archives/2008/03/silkn_hair_removal_system_fda_approved.html</link>
<guid>http://www.medgadget.com/archives/2008/03/silkn_hair_removal_system_fda_approved.html</guid>
<category>Plastic Surgery</category>
<pubDate>Mon, 24 Mar 2008 12:50:43 -0800</pubDate>
</item>
<item>
<title>KFH Novo Wound Healing Device Approved by EU</title>
<description><![CDATA[<p><img class="side" src="http://www.medgadget.com/archives/img/kfhnovofrontweb.jpg" width="100" height="206" /><strong>Kingfisher Medical</strong> just received the CE Mark of approval from the European Union to market its Novo wound healing device.  The handheld unit delivers small levels of electric current when placed in proximity to the wound, and that supposedly speeds up ATP production and overall healing of tissue around the damaged area.</p>

<p>The following is from the company's pitch:</p>

<blockquote><li>Attracting the right cells to the wound area e.g. keratinocytes (cells which make up 90% of the outer layer of skin called the epidermis)</li>
<li>Stimulating fibroblast cells to activate wound healing</li>
<li>Increasing the production of ATP, providing energy to restart tissue healing</li>
<li>Increasing the blood and oxygen supply to wound beds</li></blockquote>

<p><a href="http://www.kfhealth.com/novo/news.html?id_news=20">KFH press release</a>...</p>

<p><a href="http://www.kfhealth.com/novo/index.html">Product page</a>...</p>]]></description>
<link>http://www.medgadget.com/archives/2008/03/kfh_novo_wound_healing_device_approved_by_eu.html</link>
<guid>http://www.medgadget.com/archives/2008/03/kfh_novo_wound_healing_device_approved_by_eu.html</guid>
<category>Surgery</category>
<pubDate>Wed, 12 Mar 2008 08:23:01 -0800</pubDate>
</item>


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