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Texas Children's Hospital implants FDA approved transcatheter pulmonary heart valve

Using a newly FDA approved pulmonary valve, Dr. Frank Ing, director of the catheterization laboratory at Texas Children's Hospital and his team of pediatric interventional cardiologists implanted a transcatheter pulmonary heart valve into the heart of a 13-year-old girl, which spared her from having her chest opened for a third heart surgery.

9 Sep 2010

Consumer Reports rates heart bypass surgical groups

The New York Times: Consumer Reports will rate groups that perform heart bypass surgery. The group already rates many consumer items like cars and even household appliances. "In most parts of the country, data-based ratings of doctors are not available to patients. Only a few states, including New York, provide them.

9 Sep 2010

BK Medical launches Flex Focus 700 mobile ultrasound system

Analogic Corporation, a leading provider of medical imaging and aviation security technology, announced today that its specialized ultrasound business, BK Medical, has introduced the Flex Focus 700™, a mobile ultrasound system designed primarily for ultrasound guided surgical procedures in the operating room.

9 Sep 2010

First Edition: September 8, 2010

In today's headlines, reports about how health reform is playing on the campaign trail and the latest on health insurance premium hikes.

8 Sep 2010

STAAR Surgical's Visian Implantable Collamer Lens featured prominently at 2010 ESCRS Congress

STAAR Surgical Company, the leading worldwide developer, manufacturer and marketer of phakic intraocular lenses, today announced that the Visian Implantable Collamer® Lens (ICL) was featured prominently in more than 40 presentations by leading ophthalmologists at meetings prior to and during the 2010 Congress of European Society of Cataract and Refractive Surgeons (ESCRS) held in Paris, France from September 4 through 8, 2010.

8 Sep 2010

FDA clears Viking Systems' Next Generation 3DHD visualization system

Viking Systems, Inc. announced today that it has received clearance of its 510(k) application by the Food and Drug Administration related to its Next Generation 3DHD visualization system. The System is scheduled for market launch in Washington D.C. at this year's American College of Surgeons' Annual Clinical Congress which will be held from October 3-7.

8 Sep 2010

Study finds alternative birthing room reduces Caesarian section surgery

Giving birth in an alternative setting within a hospital like a bed-free birthing room or one designed to be "homelike" is just as safe for healthy women as laboring in a traditional hospital bed and women who use these rooms are nearly twice as likely to be satisfied with their birth experiences, according to an updated Cochrane review.

8 Sep 2010

Gemcitabine does not improve survival compared with fluorouracil plus folinic acid in resected pancreatic cancer

Use of gemcitabine, a drug that can be effective in treating advanced and resected pancreatic cancer, did not result in improved overall survival after pancreatic cancer resection (surgical removal) compared to patients who received fluorouracil and folinic acid, another treatment regimen that has shown effectiveness, according to a study in the September 8 issue of JAMA.

8 Sep 2010

TransOral Robotic Surgery removes head and neck cancer tumors, while preserving speech

An incisionless robotic surgical procedure is offering patients a new option to remove certain head and neck cancer tumors without visible scarring, while preserving speech and the ability to eat.

8 Sep 2010

NIH announces award to improve human microbiome research

The National Institutes of Health today announced it has awarded approximately $42 million to expand the scope of eight demonstration projects designed to link changes in the human microbiome to health and disease.

8 Sep 2010

Bariatric surgery before pregnancy reduces odds of developing gestational diabetes

Obese women who have bariatric surgical procedures before pregnancy were three times less likely to develop gestational diabetes (GDM) than women who have bariatric operations after delivery, according to new research findings published in the August issue of the Journal of the American College of Surgeons. The retrospective study also found that delivery after bariatric procedures was associated with reduced odds of cesarean section-an outcome associated with GDM.

8 Sep 2010

ESPAC-3 trial shows promising results to prevent pancreatic cancer

A major international trial has shown a commonly used chemotherapy drug is as effective at helping prevent pancreatic cancer returning after surgery as the more expensive standard chemotherapy treatment, reveals a study published in the Journal of the American Medical Association today (Wednesday).

8 Sep 2010

Study finds increase in bone morphogenetic protein usage for Off-Label procedures

Bone morphogenetic protein (BMP) is increasingly used as an alternative to the patient's own bone for spinal fusion surgery. Yet at least 85 percent of these procedures are operations for which BMP use has not been formally approved by the U.S. Food and Drug Administration (FDA), suggests a study in the September 1 issue of Spine.

8 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

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

CytRx commences PROACT Phase 2 clinical trial of bafetinib for advanced prostate cancer

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced initiation of the PROstate Advanced Cancer Treatment (PROACT) Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer.

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

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

Endocrine Society releases new clinical practice guideline on congenital adrenal hyperplasia

Today, The Endocrine Society released a new clinical practice guideline on the diagnosis and treatment of congenital adrenal hyperplasia (CAH). The guideline features a series of evidence-based clinical recommendations developed by an expert task force.

7 Sep 2010

Surgery News and Research

Texas Children's Hospital implants FDA approved transcatheter pulmonary heart valve

Consumer Reports rates heart bypass surgical groups

BK Medical launches Flex Focus 700 mobile ultrasound system

First Edition: September 8, 2010

STAAR Surgical's Visian Implantable Collamer Lens featured prominently at 2010 ESCRS Congress

FDA clears Viking Systems' Next Generation 3DHD visualization system

Study finds alternative birthing room reduces Caesarian section surgery

Gemcitabine does not improve survival compared with fluorouracil plus folinic acid in resected pancreatic cancer

TransOral Robotic Surgery removes head and neck cancer tumors, while preserving speech

NIH announces award to improve human microbiome research

Bariatric surgery before pregnancy reduces odds of developing gestational diabetes

ESPAC-3 trial shows promising results to prevent pancreatic cancer

Study finds increase in bone morphogenetic protein usage for Off-Label procedures

Medtronic launches CoreValve delivery system with AccuTrak Stability Layer for TAVI

K2M granted FDA clearance for CHESAPEAKE Anterior-Lumbar Stabilization System

CytRx commences PROACT Phase 2 clinical trial of bafetinib for advanced prostate cancer

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

Risk of late onset TRAS in living unrelated donor kidney recipients

Endocrine Society releases new clinical practice guideline on congenital adrenal hyperplasia

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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