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FDA approves IDE Supplement for third patient allotment in HeartWare Ventricular Assist System ADVANCE trial

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration has approved an IDE Supplement that allows HeartWare to enroll a third allotment, of 94 additional patients, in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).

25 Jan 2011

St. Georg Hospital performs two live procedures using Endoscopic Ablation System

CardioFocus announced that two "live cases" using its Endoscopic Ablation System were recently conducted. The first live case was a satellite transmission performed at Centro Cardiologico Monzino in Milan, Italy; broadcast to the 16th Annual Boston Symposium on Atrial Fibrillation in Boston, MA.

25 Jan 2011

LHSC performs complicated aortic valve bypass surgery using Correx AVB device

Doctors at London Health Sciences Centre (LHSC) are the first in the world to use a new implantable surgical device that promises to revolutionize aortic valve bypass surgery.

25 Jan 2011

Patients with chronic depression can benefit from pioneering neurosurgical treatment

Pioneering neurosurgical treatment, a world first in Bristol, which very accurately targets brain networks involved in depression, could help people who suffer with severe and intractable depression.

25 Jan 2011

Researchers discover new treatment for difficult-to-control high blood pressure

Researchers were surprised to discover what may be a potential new treatment for difficult-to-control high blood pressure, according to a case report published in the January 25, 2011, print issue of Neurology, the medical journal of the American Academy of Neurology.

25 Jan 2011

Chiropractic treatment helps female Army Brigadier General to battle against fibromyalgia

After 27 years of service, decorated U.S. Army Brigadier General Becky Halstead (Retired), the first female West Point graduate in U.S. history to command at the strategic level in Iraq and Afghanistan, decided to retire after being diagnosed with fibromyalgia - a medically unexplained syndrome affecting the muscles and connective tissues.

25 Jan 2011

ASA concerned over non-availability of sodium thiopental

The American Society of Anesthesiologists (ASA) and its members are extremely troubled to learn that the anesthetic drug, sodium thiopental (Pentothal®), will no longer be available to patients in the U.S. or any other country due to the unfortunate circumstances in Italy that led the sole manufacturer, Hospira, to cease production of the drug.

25 Jan 2011

SNM commends FDA Advisory Committee recommendation for florbetapir approval

The Society of Nuclear Medicine (SNM) commends the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee on its recent recommendation for conditional approval of a new imaging agent, florbetapir.

25 Jan 2011

FDA grants pre-market clearance for SBi's rHead Extended Stem

Small Bone Innovations, an orthopedics company focused exclusively on serving patients and their physicians with technologies and treatments for joint repair and trauma reconstruction around the small bones & joints of the thumb, fingers, hand, wrist, elbow, toes and foot & ankle announced that it has received 510(k) pre-market clearance notification from the U.S. Food and Drug Administration for the radial Head Extended Stem to be used in the correction of complex elbow instabilities and/or elbow reconstruction.

From Evident Corporation - Life Sciences 24 Jan 2011

Laparoscopic grasp instrument can reduce complications in keyhole surgery

The number of complications following keyhole surgery can be reduced by giving the surgeons a better feeling of how hard they are grasping the tissue with their operating instruments. This is made possible by designing the instrument in such a way that it sends tangible feedback signals to the handle held by the surgeon.

24 Jan 2011

Fat grafting safety review published; no increased risk of cancer

Published clinical experience in over 2,000 patients who received autologous fat grafts showed no evidence of increased risk of development, metastasis or recurrence of breast cancer in contrast to laboratory data.

24 Jan 2011

EU awards 3 million euros for improving assessment of MRI scans for Crohn’s disease

Colonoscopy is the standard intestinal examination for diagnosing and monitoring Crohn's disease. It is a stressful procedure in which a flexible tube fitted with a camera is passed into the large intestine. MRI scans are therefore often used as an alternative to monitor the course of the disease and how it is responding to treatment.

24 Jan 2011

Biomerix receives CE Mark approval for REVIVE soft tissue repair mesh

Biomerix Corporation announced today that it has received CE Mark approval for its REVIVE™ soft tissue repair mesh allowing for the marketing of REVIVE in all European Union member (EU) states. REVIVE received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2009.

24 Jan 2011

St. Jude Medical's Athena programmer DBS system receives Australian TGA approval

St. Jude Medical, Inc., a global medical device company, today announced regulatory approval from the Australian Therapeutic Goods Administration (TGA) of its Athena™ programmer, a deep brain stimulation (DBS) therapy management system.

24 Jan 2011

Boston Scientific completes enrollment in comparison trial of SYNERGY Stent to PROMUS Element Stent

Boston Scientific Corporation today announced the completion of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of the Company's fourth-generation SYNERGY™ Coronary Stent. The randomized, single-blind, non-inferiority trial will compare the SYNERGY Stent to the PROMUS Element™ Everolimus-Eluting Coronary Stent in patients with a single de novo native coronary artery lesion.

24 Jan 2011

Methodist DeBakey Heart & Vascular Center chosen for critical percutaneous heart valve study

The Methodist DeBakey Heart & Vascular Center was chosen today as a site for a critical percutaneous heart valve study. As part of the research study, Methodist physicians will replace diseased cardiac valves through a single, tiny puncture hole in the research subject's groin.

24 Jan 2011

Humber River Regional Hospital adds new MRI

York South-Weston area residents will soon benefit from reduced MRI wait times, thanks to the addition of a new MRI machine and additional funding to reduce the number of patients waiting for MRI scans at the Humber River Regional Hospital's Church St. site.

24 Jan 2011

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children.

24 Jan 2011

FDA approves On-X AAP with Vascutek Gelweave Valsalva Graft

On-X Life Technologies, announced today that it has received approval from the U.S. Food and Drug Administration to market the On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft.

23 Jan 2011

First U.S. implant of RespiCardia System for treatment of sleep apnea

Cardiac Concepts, announced today the first U.S. clinical implant of the RespiCardia System at The Ohio State University Medical Center, Columbus, Ohio.

21 Jan 2011

Medical Procedure News

FDA approves IDE Supplement for third patient allotment in HeartWare Ventricular Assist System ADVANCE trial

St. Georg Hospital performs two live procedures using Endoscopic Ablation System

LHSC performs complicated aortic valve bypass surgery using Correx AVB device

Patients with chronic depression can benefit from pioneering neurosurgical treatment

Researchers discover new treatment for difficult-to-control high blood pressure

Chiropractic treatment helps female Army Brigadier General to battle against fibromyalgia

ASA concerned over non-availability of sodium thiopental

SNM commends FDA Advisory Committee recommendation for florbetapir approval

FDA grants pre-market clearance for SBi's rHead Extended Stem

Laparoscopic grasp instrument can reduce complications in keyhole surgery

Fat grafting safety review published; no increased risk of cancer

EU awards 3 million euros for improving assessment of MRI scans for Crohn’s disease

Biomerix receives CE Mark approval for REVIVE soft tissue repair mesh

St. Jude Medical's Athena programmer DBS system receives Australian TGA approval

Boston Scientific completes enrollment in comparison trial of SYNERGY Stent to PROMUS Element Stent

Methodist DeBakey Heart & Vascular Center chosen for critical percutaneous heart valve study

Humber River Regional Hospital adds new MRI

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

FDA approves On-X AAP with Vascutek Gelweave Valsalva Graft

First U.S. implant of RespiCardia System for treatment of sleep apnea

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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