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FDA grants Teleflex 510(k) clearance for ArrowEVOLUTION PICC with Chlorag+ard technology

Teleflex Incorporated today announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the company's ArrowEVOLUTION™ PICC with Chlorag+ard™ technology, a peripherally inserted central catheter with a Chlorhexedine-based solution that has been chemically-bonded into the surface of the catheter both intra- and extralumenally. Teleflex will launch the product for general availability in the United States in the fourth quarter.

7 Sep 2010

Medtronic launches CoreValve delivery system with AccuTrak Stability Layer for TAVI

Medtronic, Inc. today announced CE Mark approval and the first global use and launch of the Medtronic CoreValve® delivery system with AccuTrak™ Stability Layer for transcatheter aortic valve implantation (TAVI). AccuTrak's proprietary technology allows physicians to achieve enhanced control and accuracy in the deployment of the CoreValve device.

7 Sep 2010

AtheroMed initiates enrollment in Phoenix Atherectomy catheter trial for PAD

AtheroMed, Inc. announced today the start of enrollment in the EASE study to evaluate the safety and effectiveness of the Phoenix Atherectomy™ catheter, a minimally invasive device for the treatment of peripheral arterial disease (PAD) in the legs. EASE - Endovascular Atherectomy Safety and Effectiveness - is an FDA-approved Investigational Device Exemption (IDE) clinical trial that will enroll 90 patients at up to 20 clinical sites.

7 Sep 2010

K2M granted FDA clearance for CHESAPEAKE Anterior-Lumbar Stabilization System

K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its new CHESAPEAKE™ Anterior-Lumbar Stabilization System, a unique interbody device designed for stabilization of the spine through an anterior approach. The system provides screw fixation through K2M's revolutionary tifix® Locking Technology, whereby each screw head forms an autogenic lock to the implant upon insertion.

7 Sep 2010

Promedior initiates PRM-151 Phase 2a clinical study in prevention of scarring post glaucoma filtration surgery

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today that it has initiated a Phase 2a clinical study of PRM-151 to evaluate the efficacy, safety, and tolerability of PRM-151 in preventing post-surgical scarring in glaucoma patients following glaucoma filtration surgery. There currently are no approved drugs for preventing post-surgical scarring in glaucoma, and there are no approved anti-fibrotic drug therapies in the U.S. or Europe for any fibrotic disease.

7 Sep 2010

GI Dynamics announces data on EndoBarrier therapy for type 2 diabetes, obesity

GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced data with the EndoBarrier Gastrointestinal Liner at 12 months showing significant weight loss and cardiovascular and metabolic improvements in obese patients.

7 Sep 2010

FDA grants IRIS clearance for analysis of synovial fluid with iQ200, iRICELL automated microscopy analyzers

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostic systems and consumables for use in hospitals and commercial laboratories worldwide and provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the analysis of synovial fluid as a new product application in its Body Fluids Module utilizing its iQ®200 and iRICELL® automated microscopy analyzers.

7 Sep 2010

Medtronic announces international launch of Resolute Integrity Stent System

Medtronic, Inc. (NYSE: MDT), announces the CE (Conformite Europeene) mark and international launch of the Resolute Integrity Stent System for the treatment of coronary artery disease, a leading cause of death and poor quality of life.

7 Sep 2010

Risk of late onset TRAS in living unrelated donor kidney recipients

Patients who have received a new kidney are significantly more likely to develop transplant renal artery stenosis (TRAS) if they are obese or over 50, according to research published in the September issue of the Journal of Renal Care.

7 Sep 2010

New blood signature test to diagnose, treat respiratory infections

Coughing and wheezing patients could someday benefit from quicker, more accurate diagnosis and treatment for respiratory infections such as flu, through a simple blood test, according to scientists.

7 Sep 2010

Combined treatment may benefit early-stage schizophrenia patients: Report

Patients with early stage schizophrenia who receive a combination of medication and a psychosocial intervention appear less likely to discontinue treatment or relapse and may have improved insight, quality of life and social functioning than those taking medication alone, according to a report in the September issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

7 Sep 2010

Survey reveals lack of public awareness about radiotherapy's importance in treating cancer

Only one in ten people know that radiotherapy helps cure forty per cent of cancer patients according to new figures published by Cancer Research UK today.

7 Sep 2010

PennHIP radiographic method may hold potential to evaluate human susceptibility to hip dysplasia

A study comparing a University of Pennsylvania method for evaluating a dog's susceptibility to hip dysplasia to the traditional American method has shown that 80 percent of dogs judged to be normal by the traditional method are actually at risk for developing osteoarthritis and hip dysplasia, according to the Penn method.

4 Sep 2010

Genetic predisposition reduces breast, ovarian cancer risk with preventive surgeries: Study

A long-term study of women with a genetic predisposition for breast or ovarian cancer showed that those who elected major preventive surgeries had a significantly reduced risk of those cancers.

4 Sep 2010

MSKCC develops new prediction tool to calculate risk for DCIS recurrence after breast-conserving surgery

The decision regarding treatment following breast-conserving surgery for patients diagnosed with ductal carcinoma in-situ (DCIS) has long been an area of discussion and confusion for patients and physicians alike. While the mortality rates for DCIS remain low, the risk of local recurrence in the breast is high. Standard treatments following surgery include radiation therapy and hormone treatment.

4 Sep 2010

CyberKnife radiosurgery treatment effective for prostate cancer without side effects

CyberKnife radiosurgery treatment for prostate cancer is rapid, effective and has no side effects, with the added benefit of being non-invasive.

3 Sep 2010

Researchers find link between surgery duration with deep venous thrombosis risk

One of the most severe complications of brain surgery is a life-threatening blood clot in the lungs called a pulmonary embolism.But a Loyola University Health System study published in the Journal of Neurosurgery suggests that screening methods hospitals typically use to access the risk of pulmonary embolisms may fall short.

3 Sep 2010

Study finds acupuncture can control side effects of cancer treatment

Recent studies have shown that acupuncture can help control a number of symptoms and side effects such as pain, fatigue, dry mouth, nausea, and vomiting associated with a variety of cancers and their treatments.

3 Sep 2010

Researchers develop gLQ Model to determine optimal dose level, treatment schedules for high-dose radiation therapies

There is yet no straightforward way to determine the optimal dose level and treatment schedules for high-dose radiation therapies such as stereotactic radiation therapy, used to treat brain and lung cancer, or for high-dose brachytherapy for prostate and other cancers.Radiation oncologists at the Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute may have solved the problem by developing a new mathematical model that encompasses all dose levels.

3 Sep 2010

Preventive surgery protects against breast, ovarian cancer in women carrying BRCA1, BRCA2 gene mutations

Women who have gene mutations that put them at high risk of ovarian and breast cancer can significantly reduce the risk of developing or dying from these cancers by having their healthy ovaries or breasts removed, according to a new study reported in the Sept. 1 issue of the Journal of the American Medical Association.

3 Sep 2010

Medical Procedure News

FDA grants Teleflex 510(k) clearance for ArrowEVOLUTION PICC with Chlorag+ard technology

Medtronic launches CoreValve delivery system with AccuTrak Stability Layer for TAVI

AtheroMed initiates enrollment in Phoenix Atherectomy catheter trial for PAD

K2M granted FDA clearance for CHESAPEAKE Anterior-Lumbar Stabilization System

Promedior initiates PRM-151 Phase 2a clinical study in prevention of scarring post glaucoma filtration surgery

GI Dynamics announces data on EndoBarrier therapy for type 2 diabetes, obesity

FDA grants IRIS clearance for analysis of synovial fluid with iQ200, iRICELL automated microscopy analyzers

Medtronic announces international launch of Resolute Integrity Stent System

Risk of late onset TRAS in living unrelated donor kidney recipients

New blood signature test to diagnose, treat respiratory infections

Combined treatment may benefit early-stage schizophrenia patients: Report

Survey reveals lack of public awareness about radiotherapy's importance in treating cancer

PennHIP radiographic method may hold potential to evaluate human susceptibility to hip dysplasia

Genetic predisposition reduces breast, ovarian cancer risk with preventive surgeries: Study

MSKCC develops new prediction tool to calculate risk for DCIS recurrence after breast-conserving surgery

CyberKnife radiosurgery treatment effective for prostate cancer without side effects

Researchers find link between surgery duration with deep venous thrombosis risk

Study finds acupuncture can control side effects of cancer treatment

Researchers develop gLQ Model to determine optimal dose level, treatment schedules for high-dose radiation therapies

Preventive surgery protects against breast, ovarian cancer in women carrying BRCA1, BRCA2 gene mutations

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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