Smith & Nephew Inc. Receives FDA 510k Clearance for a 30-year Knee

MEMPHIS, Tenn., April 22 /PRNewswire-FirstCall/ -- As evidence of its drive to return knee pain sufferers to a lifetime of physical activity, Smith & Nephew (NYSE: SNN, LSE: SN) Orthopaedics Division today announces the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity on the company's LEGION™ knee replacement, VERILAST technology produced an 81-percent reduction* in wear, the leading cause of knee replacement failure.

The Food and Drug Administration (FDA) has reviewed the results and Smith & Nephew received 510k clearance for claims related to VERILAST technology's ability to "provide wear performance sufficient for 30 years of actual use under typical conditions." The consensus of scientific literature is that knee implants are expected to last 10 to 15 years.

Press release: http://www.devicespace.com/news_story.aspx?NewsEntityId=177779

Merz Aesthetics Announces FDA Approval of Asclera(TM) (Polidocanol) Injection, First Sclerosant to Treat Small Varicose Veins in 60 Years

Company Showcases Expanded Portfolio at ASAPS

WASHINGTON, April 23 (HSMN NewsFeed) -- Following news of the acquisition of BioForm Medical, Inc. earlier this year, Merz Aesthetics, the new business unit of Merz Pharma Group, makes its debut at the prestigious American Society of Aesthetic Plastic Surgeons (ASAPS) annual meeting with the announcement of the U.S. Food and Drug Administration's (FDA) recent approval of Asclera™ (polidocanol) Injection, a sclerotherapy treatment for uncomplicated spider and reticular veins.

"Spider and reticular veins are a common, often embarrassing condition that can be treated safely and effectively," said Robert A. Weiss, M.D., director of the Maryland Laser, Skin, and Vein Institute and Associate Professor of Dermatology at Johns Hopkins University School of Medicine in Baltimore, MD. "Asclera™ is a minimally-invasive option for patients who are unhappy with the appearance of their legs."

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Flexuspine Receives FDA Conditional Approval to Begin a Feasibility Study of Its FSU (Functional Spinal Unit) Total Spine Arthroplasty System in the U

PITTSBURGH, April 22 (HSMN NewsFeed) -- Flexuspine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted conditional approval to begin the initial phase of the Investigational Device Exemption (IDE) for a feasibility study of its FSU device. This is the first approved clinical study for a Total Spine Arthroplasty system in the U.S.

Flexuspine's FSU Total Spinal Segment Replacement is designed to provide an alternative to fusion by reestablishing mobility in an affected segment of the lumbar spine. The device is composed of an interbody disc component (Core) and posterior dynamic resistance component (Dampener) and is designed as a system to restore the motion and natural kinematics of the affected spine segment.

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PureGraft Enters the Market as an Innovative New System for Safe, Fast and Reliable Fat Graft Processing

SAN DIEGO--(HSMN NewsFeed)--Cytori announces the product launch of PureGraft 250, a revolutionary fat grafting technology that standardizes the graft preparation process for use in aesthetic body contouring at the American Society of Aesthetic Plastic Surgeons (ASAPS) meeting.

“PureGraft is a game-changer in the world of fat grafting,” says San Diego-based plastic surgeon Steven Cohen, MD. “The system offers high speed and sterile preparation of a viable and functional fat graft that is ready to inject, and takes a third of the time to prepare three times the graft.”

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Gelesis Unveils Novel Non-Invasive Capsulated Device for Obesity and Presents Clinical Data; Appoints Former Pfizer R&D President to Board

BOSTON, April 22 (HSMN NewsFeed) -- Boston-based medical technology firm Gelesis, Inc. unveiled its capsulated device Attiva™, and presented data showing that Attiva™ significantly increased the post-meal feeling of satiety and reduced hunger between meals in obese patients. This data was presented today at the American Association of Clinical Endocrinologists (AACE) 19th Annual Meeting & Clinical Congress

Attiva™, the first and only superabsorbent hydrogel composed entirely from food components, is administered in the form of small particles that are designed to swell after ingestion with water and occupy the gastric and intestinal cavities, inducing a feeling of satiety that lasts beyond its transit time in the stomach. Afterwards, it safely degrades in the colon and releases absorbed liquids. When fully swollen, the product creates very small and individual gel beads that are mixed homogenously with the food in the stomach and also have the same elasticity and viscosity as foods.

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Manhattan Scientifics' Technology Able to Detect Breast Cancer Three Years Earlier Than Mammogram

New Technology 100% Radiation-Free

ALBUQUERQUE, N.M.--(HSMN NewsFeed)--Manhattan Scientifics, Inc. (OTCBB: MHTX ) announced today that its "early cancer detection" technology, developed by Edward R. Flynn, Ph.D. is expected to identify breast cancer three years earlier than the current gold standard mammogram test. Dr. Flynn is a pioneer in the emerging field of nano medicine.

When fully developed and commercialized, Dr. Flynn's biomagnetic-based system will be 100% radiation free, unlike current radiation-based mammogram tests. Manhattan Scientifics is currently seeking a partner to commercialize the technology.

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Delcath Phase III Trial Results Exceed Primary Endpoint Expectations

Treatment Arm Shows More Than 3x Median hPFS Compared to Control Arm

New York, NY -- April 21, 2010 -- Delcath Systems, Inc. (NASDAQ: DCTH), a development stage, oncology-focused, specialty pharmaceutical and medical device company, announced that its Phase III National Cancer Institute (NCI)-led multi-center clinical trial has successfully met the study’s primary endpoint of extended hepatic progression-free survival (hPFS) in patients with melanoma metastases to the liver based on an independently corroborated intent-to-treat analysis. Comparing treatment with the Delcath PHP System™ with melphalan to Best Alternative Care (BAC), based on independent core lab review of patient scans, the statistical analysis revealed that the PHP patients had a statistically significant longer median hPFS of 214 days compared to 70 days in the BAC arm (p=0.001). This reflects a 144-day prolongation of hPFS over that of BAC control arm, with less than half the risk of progression and/or death in the PHP group compared to the BAC group (Hazard Ratio = 0.46).

http://delcath.com/index.php/news/171-delcath-phase-iii-trial-results-exceed-primary-endpoint-expectations.html

Medtronic Receives FDA Approval for New Indication for Complete(R) SE Vascular Stent

Now Indicated for Treatment of Peripheral Disease in the Iliac Arteries, Self-Expanding (SE) Device Redefines Deployment Accuracy for Precise Placement

MINNEAPOLIS--(HSMN NewsFeed)--Broadening the scope of innovation for cardiovascular interventions beyond the heart, Medtronic, Inc. (NYSE: MDT ), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the Complete® SE Vascular Stent System to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries, major blood vessels within the pelvis that supply blood to the lower extremities.

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Medtronic Completes Acquisition of Invatec and Affiliated Companies

Acquisition Expands Product Offering and Pipeline for Cardiovascular Interventions

MINNEAPOLIS, April 21--(HSMN NewsFeed)--Moving to expand its product offering, Medtronic, Inc. (NYSE: MDT ), announced today that it has completed the acquisition of Invatec, a developer of innovative medical technologies for the interventional treatment of cardiovascular disease. The acquisition includes two affiliated companies: Fogazzi, which provides proprietary polymer technology to Invatec; and KRAUTH Cardio-Vascular, which has successfully grown Invatec’s market position in Germany.

Invatec has been recognized for developing novel devices for the treatment of coronary and peripheral vascular disease in collaboration with physicians, researchers and scientists. Medtronic intends to build on Invatec’s legacy of innovation through collaboration to improve and expand treatment options for patients with cardiovascular disease.

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Proteus Announces FDA Clearance of Wireless Personal Health Monitor

Company Also Completes Financing with Leading Medical Device, Pharmaceutical and Semiconductor Companies as Investors

REDWOOD CITY, Calif.--(HSMN NewsFeed)--Proteus Biomedical Inc., a pioneer in intelligent medicine, announced today that it has received 510(k) clearance from the US Food and Drug Administration to market its wireless personal health device, the Raisin Personal Monitor.

Proteus’ Raisin Personal Monitor is a miniaturized, wearable device for remote recording and analysis of heart rate, physical activity, body position and patient-logged events. This personalized physiologic information is then communicated via Bluetooth to any computerized device, such as a mobile phone for emerging mHealth applications. The monitor attaches to a patient’s skin with an adhesive layer and is worn like a Band-Aid®.

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LDR is the First to Announce Completion of Two-year Follow-Up on a Two-Level Cervical Artificial Disc IDE Study

LDR prepares PMA submission for FDA review of the Mobi-C® cervical artificial disc

AUSTIN, Texas--(HSMN NewsFeed)--LDR, a privately held company with innovative spinal implants for non-fusion and fusion applications, announced completion of the 24-month follow-up phase of its two-level IDE study on the Mobi-C® cervical artificial disc. Having previously finalized the 24-month follow-up phase of the one-level study earlier this year, LDR is now the first company to fully enroll and reach two-year follow-up on a concurrent one-level and two-level cervical artificial disc replacement study. LDR completed one-level enrollment in October 2007 and two-level enrollment in March 2008.

The Mobi-C cervical artificial disc was first introduced outside the U.S. in November 2004 and has now been used to treat over 8,000 patients worldwide, including those involved in this 2-arm IDE study. The Mobi-C design philosophy of controlled mobility respects the instantaneous axes of rotation for a return to physiological mobility of the treated level. This innovative mobile bearing is designed to reduce the transmission of stresses to the bone-implant interface, minimizing the need for invasive anchoring features such as screws or keels. Free of this invasive fixation, the Mobi-C could become an excellent option for treating two consecutive levels.

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Endosense Launches Next Generation TactiCath(R) Force-Sensing Catheter

GENEVA, April 20--(HSMN NewsFeed)--Endosense, a medical technology company focused on improving the efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has announced the commercial release of its next generation TactiCath force-sensing ablation catheter. Recently granted CE mark and unveiled this month at the DGK 2010 – German Cardiac Society meeting in Mannheim, Germany, the second generation product includes an elegantly enhanced catheter along with a feature-rich supporting system called the TactiSys™.

“Endosense is committed to bringing the best force-sensing ablation catheter technology to the electrophysiology lab, and this next generation TactiCath reflects that ongoing commitment,” said Eric Le Royer, president and chief executive officer of Endosense. “This new generation was designed in response to customer feedback to create an even more valuable clinical experience with the TactiCath for the treatment of the of cardiac arrhythmias.”

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AngioDynamics Announces First Patient Treatment and Ongoing Enrollment in the Clinical Trial of the Use of IRE Technology in the Treatment of Early St

Seven Medical Centers in Europe to Participate in Clinical Trial

QUEENSBURY, N.Y.--(HSMN NewsFeed)--AngioDynamics (NASDAQ:ANGO ) today announced the first patient treatment and growing enrollment in a pilot study of the use of the Company’s NanoKnife® Irreversible Electroporation (IRE) System in the treatment of early stage hepatocellular carcinoma (HCC), or primary liver cancer. This clinical trial is being conducted under the supervision of Professor Jordi Bruix of the Barcelona Clinic Liver Cancer Group of the University of Barcelona and Professor Riccardo Lencioni of the University of Pisa School of Medicine.

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Covidien Announces Innovation: Delivered Mobile Surgical Tour

Initiative Brings Single-Incision Laparoscopic Device and Groundbreaking Procedures to Surgeons around the Country

NORTH HAVEN, Conn.--(HSMN NewsFeed)--Covidien (NYSE: COV ), a leading global provider of healthcare products, today announced the launch of the Innovation: Delivered tour, a mobile program that will introduce surgeons, residents, nurses and hospital administrators around the country to the SILS™ Port Multiple Instrument Access Device.

The SILS Port is an advanced, single-incision laparoscopic device that reduces the four, ½-inch or smaller incisions normally associated with traditional laparoscopic surgery to just one incision in the belly button. The SILS Port procedures are used in gynecologic, bariatric and urologic surgeries, among other specialties1, 2, 3, 4.

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Interventional Spine, Inc. Announces the First US Implant of RENEW(TM), Interspinous Allograft Technology for the Treatment of Lumbar Spinal Stenosis

IRVINE, Calif., April 19 (HSMN NewsFeed) -- Interventional Spine, Inc. today announced the first commercial implant in the United States of its RENEW™ Interspinous Allograft Technology for the Treatment of Lumbar Spinal Stenosis (LSS).

The RENEW™ Implant is an interspinous process device made from allograft for the treatment of lumbar spinal stenosis. Designed for ease of implant and to provide a more "natural" interference within the spinous process, the company believes that this innovative device will improve outcomes and provide cost efficiencies to hospitals and surgeons alike.

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Contura Submits Registration Application for Aquamid(R) to the FDA

SOBORG, Denmark, April 15 (HSMN NewsFeed) -- Contura Inc. has submitted a Premarket Approval Application (PMA) for Aquamid® to the U.S. Food and Drug Administration (FDA) requesting marketing approval in the U.S. for the aesthetic treatment of moderate to severe facial wrinkles and folds.

The application includes a successful U.S. pivotal study, in which the safety and efficacy of Aquamid was compared to Medicis' Restylane® for 12 months after treatment. The study results were presented last year at the American Society of Dermatologic Surgery's Annual Meeting and at Plastic Surgery 2009, and showed that Aquamid was as effective as Restylane® at 6 months follow-up based on the study endpoints and maintained this effectiveness at 12 months follow-up. Both treatments were safe and well tolerated. Also included in the application is a study extension that followed the Aquamid-treated subjects up to two years and demonstrated a consistent effectiveness and safety profile.

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Fraxel re:store(R) Dual Laser Proven Effective in Treating Actinic Keratoses, a Common Precancerous Skin Condition

Fraxel re:store Treatment Removes Actinic Keratoses and Improves the Overall Appearance of Skin

HAYWARD, Calif., April 15 (HSMN NewsFeed) -- Solta Medical, Inc. (Nasdaq:SLTM ), a global leader in the medical aesthetics market and manufacturer of the industry's three premier brands: Thermage®, Fraxel®, and Isolaz®, today announced the new Fraxel re:store® DUAL laser system for the treatment of actinic keratoses (AK) – a precancerous skin condition caused by sun exposure. As the leader in fractional laser technology, Fraxel delivers minimally invasive clinical solutions to resurface aging and sun damaged skin.

Fraxel re:store treatment provides superior results for AKs on the face or other areas of the body displaying the signs of photodamage. In an ongoing clinical study at the Laser & Skin Surgery Center of New York, dermatologists found that treatment with the new Fraxel re:store DUAL laser resolved 86% of AK lesions. In addition, the study found improvement in skin texture and pigmentation following a Fraxel treatment.

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Smith & Nephew Expands ACTICOAT(TM) Product Portfolio

Customer input drives introduction of ACTICOAT Flex 7 Ribbon and ACTICOAT Post Op Line Extension

ST. PETERSBURG, Fla., April 15 (HSMN NewsFeed) -- The Advanced Wound Management Division of Smith & Nephew, Inc., a subsidiary of Smith & Nephew plc (LSE: SN; NYSE: SNN) will launch extensions to its ACTICOAT(TM) Silver Coated Antimicrobial Barrier Dressing portfolio at the upcoming Symposium on Advanced Wound Care Spring meeting April 17-19, 2010, in Orlando, FL. The new dressings will be highlighted at the Smith & Nephew booth, #301.

The ACTICOAT range of antimicrobial dressings helps in the management of wounds at risk for infection. The antimicrobial properties last up to seven days meaning fewer dressing changes. The launch of the ACTICOAT Flex 7 Ribbon and ACTICOAT Post-Op 4x13 3/4 wound dressings extend Smith & Nephew's unique range of antimicrobial barrier dressings for use in chronic and acute wounds. The ACTICOAT portfolio utilizes Nanocrystalline silver technology to provide an effective barrier to more than 150 wound pathogens, including 188 strains of MRSA.

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Salient Surgical Brings the Benefits of TRANSCOLLATION(TM) Technology to the Orthopedic Trauma Market

Benefits of TRANSCOLLATION(TM) Technology Brought to Pelvic Fracture, Hip and Acetabulum Fracture, Amputation, Osteotomy and Debridement Procedures

PORTSMOUTH, NH--(HSMN NewsFeed) - As part of its continuing efforts to improve patient outcomes and reduce non-routine discharges for its hospital customers, Salient Surgical Technologies, Inc. today announced the availability of its line of AQUAMANTYS® bipolar sealers for use in orthopedic trauma procedures

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Varian Medical Systems Introduces Revolutionary New TrueBeam(TM) System for High-Precision Image-Guided Radiotherapy and Radiosurgery

New technology enables a radical new approach that expands radiotherapy treatment options for even the most challenging cases

NEW YORK, April 14 (HSMN NewsFeed) -- Varian Medical Systems (NYSE:VAR ) today is announcing the introduction of a new line of "super" accelerators designed to advance the treatment of lung, breast, prostate, head and neck, and other types of cancer. The TrueBeam™ platform for image-guided radiotherapy and radiosurgery is the first fully-integrated system designed from the ground up to treat a moving target with unprecedented speed and accuracy. Varian unveiled the new line last night at a special event conducted here for members of the cancer treatment community.

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ev3 Inc. Announces First Patient Enrollments in DEFINITIVE LE Post-Market Study

Largest Study to Date Will Evaluate SilverHawk Plaque Excision System for Treatment of Lower Extremity Peripheral Arterial Disease

PLYMOUTH, Minn., April 30 /PRNewswire/ -- ev3 Inc. (Nasdaq: EVVV) today announced that the first patients were recently enrolled in the DEFINITIVE LE post-market study. DEFINITIVE LE is a prospective, multi-center, single-arm study to evaluate the intermediate and long-term effectiveness of stand-alone SilverHawk(R) Plaque Excision therapy for endovascular treatment of lower extremity peripheral arterial disease (PAD). Stuart Harlin, M.D., of Sacred Heart Hospital in Pensacola, Florida and Prakash Makam, M.D., of Community Hospital in Munster, Indiana enrolled the first two patients.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/ev3/38145/

press release >> http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/04-30-2009/0005016207&EDATE=

FDA has Granted HUD (Humanitarian Use Device) Designation to ITGI's Pericardium Covered Stents, Over and Under(R) and Aneugraft(R)

OR AKIVA, Israel, April 28 (HSMN NewsFeed) -- ITGI Medical, Ltd. (TASE: ITGI) a company engaged in research, development, manufacturing and marketing of heterologous tissue covered stents, announced that the US Food and Drug Administration (FDA) has granted HUD (Humanitarian Use Device) designation to Over and Under(R) and Aneugraft(R) Pericardium Covered Stents for treatment of perforations and dissections of native coronary arteries and Saphenous Vein Grafts.

This is the first step towards obtaining marketing approval.Over and Under(R) and AneuGraft(R) are stents 100% covered with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. Stents are commercially available in Europe, Israel and Latin America for treatment of Saphenous Vein Graft stenosis, aneurysms and for emergency situations such as perforations.

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Gore Announces Availability of Larger Diameter, Small Profile GORE EXCLUDER AAA Endoprosthesis

Minimally Invasive Treatment Now Available to Broader Patient Population

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced the May 4, 2009 availability of a 31 mm diameter version of the GORE EXCLUDER(R) AAA Endoprosthesis. The device provides physicians with a safe and effective endovascular option to treat abdominal aortic aneurysms (AAAs) in patients with aortic inner neck diameters up to 29 mm. Other important enhancements include a flat-top design that enables greater production efficiency, an additional pair of proximal anchors to help ensure excellent fixation, and a lengthening of the trunk from 7 to 8 cm to accommodate larger anatomies.

More than 87,000 GORE EXCLUDER Devices have been implanted in patients worldwide, making it a widely accepted, minimally invasive treatment option for individuals with AAA. In March 2009, the US Food and Drug Administration (FDA) approved the 31 mm diameter version. It has been available outside of the US since 2004 and has been implanted in more than 3,300 patients.

Full article >> http://salesandmarketingnetwork.com/news_release.php?pipe=0000ac177000191&ID=2027920

Study Finds Cook Medical Resonance Metallic Ureteral Stent Provides 43 Percent Cost Savings

Presentation at 2009 AUA Conference Highlights Success of Stent in Cost-Effectively Treating Benign Ureteral Obstruction

BLOOMINGTON, Ind.--(HSMN NewsFeed)--The results of a 16-month clinical study showing that the Cook Medical Resonance Metallic Ureteral Stent could remain in a patient for up to 12 months; generating a 43 percent cost savings in treating benign ureteral obstruction, will be presented by Dr. Thomas M. Turk, a member of the study’s investigative team, during a press conference at the 2009 AUA Conference in Chicago on April 27. These results are compared to alternative polymer stent treatment methods which may require more frequent stent changes throughout the year.

The study, conducted by Hector L. Lopez- Huertas, M.D.; Anthony J. Polcari, M.D.; Alex Acosta-Miranda, M.D. and Dr. Turk at Loyola University Health System, evaluated the safety, efficacy and cost of two stent options for the management of benign ureteral obstruction: polymer or metallic stents. The study found the annual costs associated with the repeated stent changes required in patients with polymer stents were approximately $23,999 as compared to patients with a metallic stent that can remain in the patient for up to 12 months, costing approximately $13,605. Therefore, the Cook Resonance Metallic Ureteral Stent was associated with an average cost savings of $10,394, representing the 43 percent reduction per patient per year.

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First Ever Prospective Fracture Study in Prostate Cancer Patients on ADT Reveals These Men Are at High Risk for Skeletal Fractures

Data from GTx’s Phase III clinical trial evaluating toremifene 80 mg for the prevention of fractures in men with prostate cancer on androgen deprivation therapy presented at 2009 Annual Meeting of the American Urological Association

CHICAGO--(HSMN NewsFeed)--GTx, Inc. (Nasdaq: GTXI ) announced today that in a recent Phase III clinical trial of advanced prostate cancer patients being treated with androgen deprivation therapy (ADT), nearly one in four placebo group subjects developed bone fractures or critical bone loss (>7% loss) within two years. This analysis of placebo group data from the Phase III clinical trial evaluating toremifene 80 mg for the prevention of bone fractures in men with prostate cancer on ADT was presented yesterday in an oral presentation at the 2009 Annual Meeting of the American Urological Association in Chicago.

An analysis of placebo group subjects from the clinical trial demonstrates the risk of fracture for men with prostate cancer on ADT. During the two year trial, 9.9% of these men had a nontraumatic fracture (morphometric vertebral fracture or clinical fragility fracture), and nearly one in four, 23.9%, experienced either a nontraumatic fracture or greater than 7% bone loss, a predetermined level of bone loss at which men were considered to be at high risk for fracture and were removed from the study for safety reasons. These data are from the modified intent to treat population: subjects who had a minimum of one dose of study drug or placebo and at least one on study radiograph, n=970.

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