(RTTNews) - Vnus Medical Technologies, Inc. on Saturday said it presented positive clinical performance data for the Vnus ClosureFAST catheter at the annual meeting of the American Venous Forum in Charleston, South Carolina. The data affirmed the efficacy and patient comfort levels of endovenous radiofrequency vein ablation using Vnus ClosureFAST.
full article >> http://www.tradingmarkets.com/.site/news/BREAKING%20NEWS/1128710/
SUGAR LAND, Texas, Feb. 26, 2008 (PRIME NEWSWIRE) -- A new publication by researchers at the Boston Children's Hospital shows that the use of Veinlite(r) transillumination improves vein access in children from 74% to 85% in the pediatric emergency department.
Vein access is a common and necessary procedure that is used to draw blood and infuse fluids in patients. Children have small veins that are hard to access, often resulting in multiple tries which increases trauma to the patient and parent. Failures to access veins often require invasive procedures that increase the risk of morbidity to the patient and increase the cost of treatment.
full article >> http://www.primenewswire.com/newsroom/news.html?d=137135
RadSciences Group is releasing the results of the most recent Radiology Compensation Review that focuses on real-time wage changes and staffing trends that have affected radiology groups and hospitals over the past year, including their recruitment and retention efforts. The Compensation Review is a free resource that provides a summary of current data and market trends in all modalities of radiology. The latest figures show a continued market demand for sonographers, vascular sonographers, cardiac sonographers and interventional technologists. The number of General, vascular and cardiac sonographer searches conducted by RadSciences Group increased from 47.9 per cent of overall searches in 2006 to 58.5 per cent in 2007.
full article >> http://www.medicexchange.com/mall/departmentpage.cfm/MedicExchangeUSA/_81675/3864/departments-contentview
The Supreme Court’s decision Wednesday protecting many types of medical device makers from personal injury lawsuits began rippling through the courts and law offices almost immediately.
Hours after the decision in the case, Riegel v. Medtronic, was announced, lawyers involved in a group of Florida state court cases related to Johnson & Johnson’s drug-coated Cypher heart stent received an e-mail message from Judge Mary Barzee Flores asking for briefs on whether the lawsuits should be allowed to continue.
And lawyers for patients with injuries they attribute to other devices like heart valves, artificial hips and defibrillators said they were girding for a flood of court filings from device makers like Medtronic asking judges to dismiss such lawsuits.
full article >> http://www.nytimes.com/2008/02/22/business/22device.html?ref=business
Mitchell Accepts CEO Position of Start-up Medical Device Company
QUEENSBURY, N.Y. February 19, 2008—AngioDynamics (NASDAQ: ANGO), a leading provider of innovative medical devices used by interventional radiologists, nephrologists, and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease, announced today that Robert D. Mitchell, the Company’s Chief Operating Officer, has resigned his position effective February 29, 2008 to become the CEO of Nellix Endovascular, a start-up medical device company.
“I thank Bob Mitchell for his efforts and contributions over the past 14 months and wish him well as he pursues the next chapter of his career,” said Eamonn Hobbs, President & CEO. “Over the past year, we have strengthened our senior management team. While I will be assuming many of Bob’s responsibilities, others will add some responsibilities. We expect a smooth transition and a continuation of our recent positive momentum.”
full article >> http://www.angiodynamics.com/pages/news/news_articles_detail.asp?id=244
Boston, MA - A paclitaxel-coated balloon may end up filling a role never successfully filled by drug-eluting stents (DES): angioplasty of the leg. According to Dr Gunnar Tepe (Eberhard-Karls-Universitat, Tubingen, Germany) and colleagues, use of a paclitaxel-eluting balloon was significantly more effective in terms of reducing need for revascularization than either a bare, uncoated balloon or a bare balloon coupled with paclitaxel-infused contrast medium [1].
full article >> http://www.theheart.org/article/843165.do
SOUTH JORDAN, Utah, Feb. 13, 2008 (PRIME NEWSWIRE) -- Merit Medical Systems, Inc. (Nasdaq:MMSI), a manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures, announced today that the Company has finalized two transactions.
On November 5, 2007, Merit announced that it had entered a non-binding term sheet to acquire cardiac and peripheral catheter platform assets from Micrus Endovascular. On January 31, 2008, Merit finalized a definitive asset purchase and supply agreement effecting the transaction.
Additionally, the Company said that is has entered into an agreement with Timothy Clark, M.D., to acquire intellectual property rights relating to U.S. Patent #7,087,060, Methods for Obtaining Hemostasis of Percutaneous Wounds.
full article >> http://money.cnn.com/news/newsfeeds/articles/primenewswire/136283.htm
February 12, 2008 -- Somerset, New Jersey -- With its unique double angle to facilitate the selection of vessels that lie at, or originate at, difficult to access angles and take-offs, the Bolia curve is among the new additions to the Terumo Glidewire Hydrophilic Coated Guidewire product line.
In a continuous effort to provide physicians with new tools to help ensure procedural success, Terumo Interventional Systems has expanded its Glidewire product line to include 11 new guidewire configurations including a brand new tip shape design, the Bolia curve.
The Bolia curve, named for Dr. Aman Bolia who helped Terumo develop this unique tip shape, is designed to facilitate selection of vessels that are difficult to access.
Already having an extensive selection of hydrophilic coated nitinol wires, including a wide choice of 0.018” and shapeable tip Glidewires, Terumo has further expanded its offering as a response to customers’ requests. The additions include the unique 1 cm taper, available in different lengths and stiffness, as well as an 80 cm 0.035” and 0.038” Glidewire.
full article>> http://www.ptca.org/news/2008/0212_TERUMO.html
German pharmaceutical and chemical company Bayer AG agreed to buy Possis Medical Inc. in a $361 million deal that will help Bayer expand its footprint in the field of cardiovascular health technology.
The all-cash deal, set to close later this quarter, is for $19.50 a share, a 36% premium to Friday's closing price for Possis of $14.35. The stock hasn't traded at $19.50 since 2004.
The proposed combination of Bayer's Medrad subsidiary and Possis will join a provider of systems used to diagnose cardiovascular and other diseases with a maker of devices used to treat narrowed or blocked arteries.
full article >> http://online.wsj.com/article/SB120273475957358689.html?mod=googlenews_wsj
Leading Vascular Surgeons Treat First U.S. Patient in Groundbreaking Trial at Thomas Jefferson University Hospital
BLOOMINGTON, Ind.--(BUSINESS WIRE)--Cook Medical today announced enrollment of the first U.S. patient in the STABLE global clinical trial designed to evaluate the Cook Zenith® Dissection Endovascular System for the treatment of Type B thoracic aortic dissections. This is the first device designed specifically to treat aortic dissections, the condition that took the life of actor John Ritter. The technologically advanced device is the first-of-its-kind worldwide and was designed to treat the unique morphology of this disease, a major cause of mortality worldwide.
press release >> http://www.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20080211005332&newsLang=en
MONDAY, Feb. 11 (HealthDay News) -- Baxter HealthCare Corp., which produces half of the blood thinner heparin sold in the United States, said Monday that it was temporarily suspending production of its multi-dose injectable form of the drug following reports of serious allergic reactions and possibly four patient deaths.
The cause of the allergic reactions isn't known. It's also not clear how long production will be stopped. The one thing that is clear is that the stoppage could lead to a shortage of heparin, which is used to prevent blood clots in such patients as those undergoing kidney dialysis and heart surgery, U.S. health officials said.
Since the end of December, there have been about 350 reports of adverse reactions associated with Baxter's heparin product. This compares with less than 100 reports of adverse reactions in all of 2007, Dr. John Jenkins, director of the U.S. Food and Drug Administration Office of New Drugs at the Center for Drug Evaluation and Research, said during a Monday teleconference.
full article >> http://www.forbes.com/forbeslife/health/feeds/hscout/2008/02/11/hscout612578.html
Urol Oncol. 2008 Jan-Feb;26(1):102.
Stern JM, Svatek R, Park S, Hermann M, Lotan Y, Sagalowsky AI, Cadeddu JA, Department of Urology, University of Texas, Southwestern Medical Center, Dallas, TX.
Boorjian SA, Blute ML.
OBJECTIVE: To compare the intermediate term outcomes of patients with clinical T1a renal tumors who were treated with nephron-sparing surgery by partial nephrectomy (PN), the preferred approach for small (cT1a) renal tumors, or radiofrequency ablation (RFA), recently offered to selected patients as an alternative, less morbid technique. PATIENTS AND METHODS: We identified patients with stage T1a renal masses who had >/=2 years of follow-up; those with bilateral synchronous or metachronous tumors, metastatic disease at presentation, or a family history of renal cell carcinoma were excluded. From July 1996 to January 2004, 110 PNs were identified in our database; 37 patients who fulfilled the inclusion criteria had either open (30) or laparoscopic PN (7), and 40 had either percutaneous (26) or laparoscopic (14) RFA. RESULTS: The mean (range) follow-up for the RFA and PN groups was 30 (18-42) and 47 (24-93) months, respectively; the respective mean tumor size was 2.41 and 2.43 cm. There was 1 incomplete ablation and 2 local recurrences in the RFA group, and 2 recurrences in the PN group (1 local and 1 in the contralateral kidney). There were no disease-specific deaths. The overall actuarial disease-free probability for the PN and RFA groups, respectively, was 95.8% and 93.4% (P = 0.67). CONCLUSIONS: This initial 3-year actuarial analysis showed that RFA for cT1a renal tumors has comparable oncological outcomes to PN; however, longer term data are still needed.
PLYMOUTH, Minn., Feb 08, 2008 /PRNewswire-FirstCall via COMTEX/ -- ev3 Inc. (Nasdaq: EVVV), a global endovascular device company, today announced the resignation of Dr. John Simpson from his position as Chief Scientist and from the company's board of directors effective February 7, 2008.
"Over the last thirty years, few people have shaped the treatment of cardiovascular disease as much as Dr. John Simpson with his numerous inventions and vision for improving the lives of patients worldwide," said Jim Corbett, chairman, president and chief executive officer of ev3 Inc. "He leaves a legacy of innovation and a foundation on which we intend to build in our effort to improve patient treatment."
full article >> http://www.foxbusiness.com/markets/industries/health-care/article/ev3-accepts-resignation-dr-john-simpson_472442_10.html
Madison, Wis. - NeuWave Medical, a Madison-based medical device company that has landed $4.5 million in venture capital to further develop a microwave probe that destroys tumors, will try to capture a global market conservatively estimated at more than $200 million, according to one of its founding researchers. Daniel van der Weide, who developed the new microwave technology to ablate, or destroy cancerous tumors along with his University of Wisconsin-Madison colleague Fred T. Lee Jr, said there are a number of potential applications for the device, a minimally invasive microwave probe that is inserted into a patient like a needle to deliver microwaves that destroy tumors.
full article >> http://wistechnology.com/article.php?id=4529
J Vasc Surg. 2007 Dec;46(6):1242-7.
Desmyttère J, Grard C, Wassmer B, Mordon S.
S.E.L. Angéio-Phlébo Interventionnelle, France.
BACKGROUND: In recent years, endovenous laser treatment (ELT) has been proposed to treat incompetent great saphenous veins (GSV). This study reports the long-term outcome of ELT in a series of 500 patients. METHODS: Incompetent GSV segments in 500 patients (436 women, 64 men) with a mean age of 52.6 years (range, 19 to 83 years) were treated with intraluminal ELT using a 980-nm diode laser (Pharaon, Osyris, France). The GSV diameter was measured by Duplex examination in an upright position in different GSV segments (1.5 cm below the saphenofemoral junction, crural segment, condylar segment, and sural segment). These measurements were used to determine the optimal linear endovenous energy density (LEED) for each segment. During treatment, patients were maintained in the Trendelenburg position. Patients were evaluated clinically and by duplex scanning at 1 and 8 days, 1 and 6 months, and at 1, 2, 3, and 4 years to assess treatment efficacy and adverse reactions. RESULTS: A total of 511 GSVs were treated. The mean diameter was 7.5 mm (range, 2.4 to 15.0). The LEED was tuned as a function of the initial GSV diameter measured in the orthostatic position, from 50 J/cm (3 mm) up to 120 J/cm (15 mm). At the 1-week follow-up, 9.3% of the patients reported moderate pain. In the immediate postoperative period, the closure rate was 98.0% and remained constant during the 4-year follow-up to reach 97.1%. After 1 year, a complete disappearance of the GSV or minimal residual fibrous cord was noted. Major complications have not been detected; in particular, no deep venous thrombosis. Ecchymoses were seen in 60%, transitory paresthesia was observed in 7%. There was no dyschromia, superficial burns, thrombophlebitis, or palpable indurations. Complementary phlebectomy was done in 98% of patients. Failures occurred only in large veins (saphenofemoral junction diameter >1.1 cm or for GSV truncular diameter >0.8 cm) CONCLUSION: ELT of the incompetent GSV with a 980-nm diode laser appears to be an extremely safe technique, particularly when the energy applied is calculated as a function of the GSV diameter. It is associated with only minor effects. Currently, ELT has become the method of choice for treating superficial veins and has almost replaced the treatment of traditional ligation and stripping.
Clin J Am Soc Nephrol. 2008 Feb 6 [Epub ahead of print]
Chan MR, Bedi S, Sanchez RJ, Young HN, Becker YT, Kellerman PS, Yevzlin AS.
Section of Nephrology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin; University of Wisconsin School of Pharmacy, Social and Administrative Sciences, Madison, Wisconsin; and Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
BACKGROUND: While endovascular stent placement is the standard of care in most percutaneous coronary and peripheral artery intervention, its role in the salvage of thrombosed and stenotic hemodialysis access remains controversial. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: We compared the effects of stent versus angioplasty on primary patency rates in the treatment of stenotic arteriovenous fistulae (AVF) and arteriovenous grafts (AVGs). Moreover, we compared access flow (Qa) and urea reduction ratio (URR) between the two groups as a metric of the effect of stent placement versus angioplasty on dialysis delivery. RESULTS: Cox regression analysis revealed that the primary assisted AVG patency was significantly longer for the stent group compared with angioplasty, with a median survival of 138 versus 61 d, respectively (aHR = 0.17; 95% confidence interval, 0.07 to 0.39; P < 0.001). The primary AVG patency for stent versus angioplasty was 91% versus 80% at 30 d, 69% versus 24% at 90 d, and 25% versus 3% at 180 d, respectively. The primary assisted AVF patency did not differ significantly between the stent and angioplasty groups. In patients dialyzing via AVF, multiple regression analysis revealed that stent placement was associated with improved after intervention peak Qa, 1627.50 ml/min versus 911.00 ml/min (beta = 0.494; P = 0.008), change in Qa from before to after intervention, 643.54 ml/min versus 195.35 ml/min (beta = 0.464; P = 0.012), and change in URR from before to after intervention, 5.85% versus 0.733% (beta = 0.389; P = 0.039). CONCLUSIONS: Our results suggest that stent placement is associated with improved AVG primary assisted patency and improved AVF blood flow, which may significantly impact on dialysis adequacy.
First ever imaging system that incorporates phased Array IVUS, Rotational IVUS and integrated FFR all onto a single platform, providing Physicians and Administrators Choice
February 07, 2008: 04:05 PM EST
SAN DIEGO, Feb. 7 /PRNewswire-FirstCall/ -- Volcano Corporation , a leading manufacturer of intravascular ultrasound (IVUS) and functional measurement (FM) technology, announced today FDA 510(k) clearance of the s5-Revo and s5-FFR (fractional flow reserve) options. These two new product offerings now enable rotational IVUS and FFR to operate on the same integrated Volcano s5 Imaging System as Volcano's previous line of phased array IVUS catheters and functionality. For the first time, physicians can choose among three powerful diagnostic tools -- all on the same integrated IVUS platform.
full article >> http://money.cnn.com/news/newsfeeds/articles/prnewswire/AQTH13707022008-1.htm
1: Dermatol Surg. 2008 Jan 31 [Epub ahead of print]
Park SJ, Yim SB, Cha DW, Kim SC, Lee SH.
Department of Phlebology, Samsung Vein Surgery Clinic, Dunsan-dong, Seo-gu, Daejeon, Korea.
BACKGROUND Whereas numerous studies have been conducted regarding the outcome of the treatment of the great saphenous vein, few studies have been conducted on the small saphenous vein (SSV), especially concerning endovenous laser treatment. OBJECTIVE The objective was to evaluate the safety and efficacy of the 980-nm diode laser for the treatment of SSV reflux caused by saphenopopliteal junction (SPJ) incompetence. MATERIALS AND METHODS From October 2003 to April 2006, 390 SSVs in 344 subjects with varicose veins were treated with 980-nm diode laser energy delivered percutaneously into the SSV. Tumescent anesthesia (70-220 mL of 0.1% lidocaine) was delivered perivenously under ultrasound (US) guidance. The patients were evaluated clinically and with duplex US at 1 week, 1 month, 3 months, 6 months, 1 year, and thereafter to assess the efficacy of the treatment and the adverse reactions of the patients to it. RESULTS Successful occlusion of the SSV, defined as the absence of flow on color Doppler imaging, was noted in 389 of the 390 SSVs (99.7%) after the initial treatment. The remaining 1 SSV was closed after the repeat treatment. Of 108 SSVs, 102 (94.4%) remained closed throughout the 12th-month follow-up. Bruising and tightness along the course of the treated vein was present in almost all the patients, but these disappeared in 1 to 2 weeks. Seven patients (2%) noted localized skin paresthesia, but there were no major complications like skin burns and deep vein thrombosis. CONCLUSION Taking into account the high failure rates of incompetent SSV surgery and the anatomic complexity of SPJ, the endovenous 980-nm diode laser surgery is a safe and effective, cosmetically preferential procedure while a long-term follow-up is being awaited.
Listed according to date of approval:
New Star Lasers: cooltouch models ns 160 and lc215 coolip;
Volcano Corporation: volcano s5/s5i intravascular imaging and ; eagle eye gold ivus imaging catheter, mo
C.R. Bard: vaccess pta balloon dilatation catheter ; recovery g2 filter system - femoral deli
Vascular Solutions: vari-lase wire fiber
FlowCardia: microsheath xl catheters
MicroVention: hydrocoil embolic systems (hes)
Arrow: pressure injectable picc
Spire: decathlon gold twin lumen hemodialysis c
AngioDynamics: angiodynamics, inc., nevertouch ii 400um
AngioTech: skater biliary catheter
Possis: angiojet ultra avx thrombectomy set, mod
Biolitec: ceralas d 980nm diode laser, models d15
Specialized Health Products: safestep max power-injectable infusion s
Lake Region: pegasus steerable (ptca) guidewire
Graftcath: hero vascular access device
ST. PAUL, Minn.--(BUSINESS WIRE)--Transoma Medical, Inc., announced this morning that it is postponing its initial public offering due to unfavorable market conditions. Transoma expects to proceed with the IPO at a future date and will evaluate market conditions to determine the appropriate timing.
A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This news release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification of the securities under the securities laws of that state.
A copy of the preliminary prospectus related to the offering may be obtained by contacting Piper Jaffray & Co., U.S. Bancorp Center, 800 Nicollet Mall, Minneapolis, Minnesota 55402.
About Transoma Medical, Inc.
Transoma Medical, Inc., headquartered in St. Paul, Minnesota, is a medical technology company engaged in developing, manufacturing and distributing implantable, subcutaneous, wireless diagnostic and monitoring products. Transoma is focused on two distinct markets - the chronic cardiovascular disease (CVD) market, through its Patient Management Device (PMD) division, and the biomedical research market, through its Data Sciences International (DSI) division.
Transoma’s PMD division is focused on developing implantable, ambulatory monitoring systems that provide physicians with vital signs information that is important to accurately diagnose various forms of CVD, and to optimize drug, interventional, surgical and device treatment alternatives. Transoma’s DSI division is the leading supplier of wireless, physiologic monitoring equipment and a significant supplier of related data acquisition and analysis products used in biomedical research, including in preclinical drug discovery and development.
SUMMIT, N.J., Feb. 6, 2008 (PRIME NEWSWIRE) -- CorMedix Inc., a New York-area biopharmaceutical company, announced today that it had acquired exclusive worldwide rights to develop, manufacture and market Neutrolin(r), a liquid that "locks" a patient's central venous catheter (CVC) between hemodialysis (HD) sessions to keep it free of infection and clots.
"We hope Neutrolin(r) will be a paradigm-changing weapon in fighting one of the single greatest causes of morbidity and mortality among the 300,000 kidney failure patients in the U.S. who undergo life-sustaining HD treatments," said Bruce Cooper, M.D., President and Chief Executive Officer of CorMedix.
More than 25 percent of HD patients rely on a CVC for vascular access. Recent estimates suggest that up to 160,000 new cases of catheter-related blood stream infection (CRBSI) emerge each year in HD alone. At best, these infections result in the need for antibiotics; at worst, they result in catheter replacement, hospitalization and possibly premature death. (American Journal of Kidney Diseases 51 (2) 2008: pp. 165-168)
full article >> http://www.primenewswire.com/newsroom/news.html?d=135819
J Vasc Surg. 2008 Jan 31 [Epub ahead of print]
Morrison N, Neuhardt DL, Rogers CR, McEown J, Morrison T, Johnson E, Salles-Cunha SX.
Morrison Vein Institute.
OBJECTIVE: This clinical study evaluated prospectively adverse events immediately following ultrasound-guided foam sclerotherapy (UGFS) for the treatment of lower extremity venous valvular insufficiency. Incidence of side effects associated with carbon dioxide (CO(2)) foam was compared with a historical control using air-based foam. The literature on the subject was reviewed. METHODS: Vital signs were monitored during and immediately after UGFS, and adverse events were recorded for 24 hours following the procedure. The air-based foam group had 49 patients: 44 women and 5 men. The CO(2)-based foam group had 128 patients: 115 women and 13 men. CEAP class was C2EpAsPr, describing varicose veins, primary etiology, and saphenous reflux. UGFS followed thermal ablation of the great saphenous vein. Foam was prepared using the three-way tap technique to mix gas with 1% polidocanol in a 4:1 ratio. Segments of the great and small saphenous veins and their tributaries were treated with UGFS. Foam volumes injected were 27 +/- 10 (SD) (6-46 range) and 25 +/- 12 (6-57 range) mL for air- and CO(2)-based foams respectively (P = .39). Incidence of adverse events was compared by chi(2) statistics. Vital signs were compared by paired t test. RESULTS: During the procedure, the average heart rate decreased by less than 5 bpm for both groups (P < .001), and blood pressure decreased by less than 3 mm Hg in the CO(2) group (P < .02). Respiratory rate, electrocardiogram, and pulse oxymetry did not change significantly in both air- and CO(2)-foam series (P > .05). Visual disturbances were experienced by 3.1% (4/128) and 8.2% (4/49) patients in the CO(2) and air groups respectively (P = .15). Respiratory difficulties or circumoral paresthesia each occurred in 0.8% (n = 1) of the CO(2) patients. Incidence of chest tightness (3.1% vs 18%), dry cough (1.6% vs 16%), or dizziness (3.1% vs 12%) were significantly lower in the CO(2) vs air groups (P < .02). Nausea occurred in 2% and 4% of the CO(2) and air-based foam groups (P = .53). Overall, the proportion of patients describing side effects decreased from 39% (19/49) to 11% (14/128) as CO(2) replaced air for foam preparation (P < .001). Similar findings were described in the literature of air-based foam but data on the use of physiological gas were rare. CONCLUSIONS: Side effects decreased significantly if CO(2) rather than air was employed to make the sclerosing foam for chemical ablation of superficial veins of the lower extremity.
PALO ALTO and SANTA ROSA, Calif., Feb. 4 (HSMN NewsFeed) -- CV Therapeutics, Inc. (Nasdaq: CVTX ) and Medlogics Device Corporation announced today that the companies have entered into an agreement under which Medlogics has licensed CV Therapeutics' proprietary biopolymer stent coating technology to develop a drug eluting stent (DES). CV Therapeutics received Medlogics stock and is entitled to development milestone payments, royalties and other potential payments on future sales of any products incorporating the technology.
Medlogics recently received a CE Mark from European regulatory authorities for its Cobalt Super Alloy (COBRA) stent and expects to launch the stent in Europe in the first quarter of 2008. Medlogics expects to utilize CV Therapeutics' biopolymer stent coating technology to develop a next- generation DES based on the COBRA stent platform.
full article >> http://salesandmarketingnetwork.com/news_release.php?ID=2023071
IRVINE, Calif.--(HSMN NewsFeed)--Endologix, Inc. (Nasdaq:ELGX ), developer and manufacturer of the Powerlink® System endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms (AAA), today noted a study published in the January 31, 2008 New England Journal of Medicine comparing results of AAA repair following open surgery and endovascular repair. Based on a review of 45,660 Medicare discharges, the study authors found that significantly more patients were discharged to home following endovascular repair, and that the laparotomy necessary to perform open repair carried its own risk for re-hospitalizations due to serious medical problems, such as abdominal wall hernia and bowel resection.
full article >> http://salesandmarketingnetwork.com/news_release.php?ID=2023075
Simple urine test leads to more accurate diagnoses, fewer false-positive results
PHILADELPHIA - An experimental biomarker test developed by researchers at the University of Michigan more accurately detects prostate cancer than any other screening method currently in use, according to a study published in the February 1 issue of Cancer Research, a journal of the American Association for Cancer Research.
The researchers say a simple urine test that screens for the presence of four different RNA molecules accurately identified 80 percent of patients in a study who were later found to have prostate cancer, and was 61 percent effective in ruling out disease in other study participants.
This is far more accurate than the PSA blood test currently in use worldwide, which can accurately detect prostate cancer in men with the disease but which also identifies many men with enlarged prostate glands who do not develop cancer, researchers say. Even the newer PCA3 test, which screens for a molecule specific to prostate cancer and which is now in use both in the U.S. and Europe is less precise, they say.
full article >> http://www.aacr.org/home/public--media/news-releases.aspx?d=956
HAYWARD, Calif., Feb. 1 (HSMN NewsFeed) -- Thermage, Inc. (Nasdaq: THRM ) today announced the introduction of the ThermaTip(TM) CL treatment tip and the Cellulite procedure by Thermage at the American Academy of Dermatology's (AAD) annual meeting in San Antonio, Texas. The Cellulite procedure by Thermage uses the FDA cleared ThermaCool® system for the temporary improvement in the appearance of cellulite.
According to a study published in 2007 by the Millennium Research Group, nearly 90 percent of women experience some degree of cellulite, and demand for non-invasive cellulite treatments in the U.S. is expected to nearly double to over 750,000 procedures per year by 2011.
Full text >>
Data reveals lower rates of short-term patient mortality and complications for abdominal aortic aneurysm patients treated with less invasive technique
BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical today applauded a new study that appeared in this week’s issue of the New England Journal of Medicine. The matched cohort observational study compared the survival and complication rates of abdominal aortic aneurysm (AAA) Medicare patients treated with endovascular aneurysm repair (EVAR), as opposed to the more traditional, open surgical method. The four-year, 23,000-patient study, conducted by vascular surgeons at Beth Israel Deaconess Medical Center and Harvard Medical School, found that the short-term rates of death and complication were significantly lower with EVAR: 1.2 percent compared to 4.8 percent for patients who underwent open surgery.
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The U.S. Food and Drug Administration on Friday approved the sale of a new drug-coated stent from Fridley-based Medtronic - a product that likely will take sales from rival Boston Scientific's nearby stent division in Maple Grove.
Called Endeavor, the product is the first new competitor in the multibillion dollar U.S. market for drug-coated stents since 2004, when the FDA approved Boston Scientific's market-leading Taxus product to compete against the Cypher stent from New Jersey-based Johnson & Johnson.
full article >> http://www.twincities.com/business/ci_8144016
ROCKVILLE, Md., Feb. 1 -- The FDA's recent warning about deaths caused by radiofrequency ablation of lung tumors was more a note of caution than a mortal blow to the procedure, said interventional radiologists experienced with the technique. The warning may simply signal that the procedure is in the midst of the awkward 'tween years, said Christos Georgiades, M.D., Ph.D., of Johns Hopkins. "Based on the experience of many physicians, including myself," he said, "we know this procedure can offer huge benefits to selected patients."
He characterized the warning as "something that all procedures and all specialties go through. We are sort of living in a grey zone right now."
The FDA's Dec. 11 notice cautioned that radiofrequency ablation of lung tumors had caused deaths reported both to the agency's MedWatch voluntary reporting program and in the literature.
"Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities," according to the notice.
full article >> http://www.medpagetoday.com/Pulmonary/LungCancer/tb/8111
HOUSTON--(HSMN NewsFeed)--IDEV Technologies, Inc.(”IDEV”), an emerging leader in the development and marketing of minimally invasive stent technologies, today announces receipt of 510(k) clearance for a new SUPERA™ Biliary Stent Delivery Catheter. The improved SUPERA™ Transhepatic Biliary System is indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. The new SUPERA™ Biliary Stent Delivery Catheter is the first to offer a retrieval capability of up to 95% for a partially deployed SUPERA Biliary Stent.
The SUPERA™ Biliary Stent Delivery Catheter also provides the operator with enhanced control during a procedure. A unique reciprocating ratchet mechanism allows the operator to precisely place the stent in the biliary tract.
Syneron(TM) Medical Ltd. (NASDAQ: ELOS), an innovator in the development, marketing and sales of elos(TM) combined-energy medical aesthetic devices, today announced the company will preview two new technologies at the annual meeting of the American Academy of Dermatology (AAD) in San Antonio, Texas on February 2-4: the Matrix RF(TM) and a laser-assisted lipolysis system.
The Matrix RF applicator utilizes Syneron's patented Bi-Polar Radio Frequency technology to provide effective and comfortable skin rejuvenation. The tunable applicator, which may be used on Syneron's eLight(TM), eLaser(TM) and eMax(TM) platforms, allows for the adjustment of ablation and coagulation settings to vary treatment depth and the proportion of skin treated in each session. The Matrix RF will also feature a single-use disposable. The Matrix RF is the second product in Syneron's series of elos fractional treatments, which currently includes the Matrix IR(TM) device. Like all of Syneron's specialized applicators, the Matrix RF will be sold as an upgrade to the elos platforms, to be used along with other Syneron applicators to expand the range of aesthetic treatments physicians can offer from each eSeries platform.
full article >> http://money.cnn.com/news/newsfeeds/articles/marketwire/0355506.htm
SAN DIEGO, Jan. 31 /PRNewswire/ -- MedWaves, Inc. announces the receipt of USFDA 510k clearance to market its patented Microwave Coagulation/Ablation System for general surgery use for the coagulation and ablation of soft tissues. The system is comprised of a microwave generator and single patient use sterile devices. The clearance sets the stage for rapid expansion of a product portfolio and indications for use through additional USFDA submissions and clearances. The Company's proprietary technology allows for the development of minimally invasive devices in wide range of sizes, shapes and flexibility to meet clinicians' requirements in bone, liver, lung and other tumors.
About The Avecure(TM) Ablation System
MedWaves Microwave Coagulation/Ablation System overcomes limitations of existing microwave and radiofrequency (RF) thermal ablation technologies, the standard of treatment for oncology patients who are not candidates for surgery. Initially the Company focused on the general use of its coagulative technology with a high percentage of the anticipated use in patients with bone, liver and lung tumors. For these patients, adjunctive use of microwave ablation can assist in the curative and/or palliative goals of standard therapies e.g. chemotherapy and/or radiation. It can be an option for patients where other thermal modalities are not possible due to tumor size or location.
press release >> http://sev.prnewswire.com/health-care-hospitals/20080131/LATH11331012008-1.html
