New Shoulder Surgery Successfully Treats Serious Injuries

A surgeon at the Emory Sports Medicine Center has helped to pioneer a surgical option for people suffering from severe shoulder injuries.

Spero Karas, MD, Emory orthopaedic surgeon and team doctor for the Atlanta Falcons, has found safe and effective results using a procedure called the “Bridge Technique” for rotator cuff injuries. This procedure uses a skin graft that is surgically attached to both the deficient tendon and bone to ‘bridge’ the defect.

“We have a number of treatments available to fix most rotator cuff injuries, but there are times when the tendon defect is so severe that those options are inadequate,” says Karas, who is also an associate professor of orthopaedics at Emory University School of Medicine.

For individuals with severe injuries that were untreatable in the past, this is a procedure that now offers a potential alternative.

"When the rotator cuff is repaired using this technique, it reestablishes normal function of the rotator cuff," Karas explains. "This results in eliminating pain, improving function and potentially slowing the progression of arthritis."

Not only does this procedure offer help for patients who may never have been able to completely recover from a serious injury, but Karas says it also may give the patient the ability to return to normal activity.

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Geron Initiates Clinical Trial of Human Embryonic Stem Cell-Based Therapy in Patients with Spinal Cord Injury

(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN) today (Octoberf 11) announced the enrollment of the first patient in the company’s clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1. The primary objective of this Phase I study is to assess the safety and tolerability of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.

“Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies”

The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, GA. Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial.

“Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “When we started working with hESCs in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials. This accomplishment results from extensive research and development and a succession of inventive steps to enable production of cGMP master cell banks, scalable manufacture of differentiated cell product, and preclinical studies in vitro and in animal models of spinal cord injury, leading to concurrence by the FDA to initiate the clinical trial.”

“We are pleased to have our patients participating in this exciting research,” said Donald Peck Leslie, M.D., medical director, Shepherd Center. “Our medical staff will evaluate the patients’ progress as part of this study. We look forward to participating in clinical trials that may help people with spinal cord injury.”

David Apple, M.D., Shepherd Center’s medical director emeritus and principal investigator of the trial at Shepherd Center, said, “This clinical trial represents another step forward in Shepherd Center’s involvement in an attempt to find a cure for paralysis in people with spinal cord injury. Shepherd Center is an ideal place to conduct this study because of our clinical expertise and the volume of patients referred here for rehabilitation care.”

In addition to Shepherd Center, Northwestern Medicine in Chicago, IL is also open for patient enrollment. As additional trial sites come online and are ready to enroll patients, they will be listed on the Patient Information pages of Geron’s website at www.geron.com/patients/clinicaltrials/hESC.aspx and on the NIH clinical trials registry, ClinicalTrials.gov, at clinicaltrials.gov/ct2/show/NCT01217008?term=GRNOPC1&rank=1.

Further information on the criteria for patient eligibility for the study is also available on ClinicalTrials.gov.

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Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System

Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.

Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.

Thoratec is voluntarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. In five cases, pump replacement was not feasible and the patients expired.

The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.

Hospitals are being sent an Urgent Medical Device Correction letter identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter. The labeling for the HeartMate II LVAS will be revised with the updated risk information related to percutaneous lead damage. Copies of this press release may be found on Thoratec’s website, www.thoratec.com, under Investor Relations/Press Releases.

Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).

FDA has been informed of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787
• Fax: 1-800-FDA-0178

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FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain

The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.

Companies must stop manufacturing unapproved BSS products on or before Nov. 24, 2008, and must stop shipping such unapproved products on or before Jan. 21, 2009. After these dates, all unapproved BSS products must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved BSS products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company.

Today's action does not affect approved ophthalmic BSS products.

Companies marketing any unapproved topical drug products containing papain must stop manufacturing them on or before November 24, 2008. Companies or others engaged in shipping these products must stop shipping these products on or before Jan. 21, 2009. After these dates, all topical products containing papain must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved topical papain products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company.

No topical drug product containing papain has been approved by the FDA.

Companies that do not comply with the designated timelines may face further FDA action, including enforcement action. If FDA takes enforcement action against a company that continues to market an unapproved product after the stated timeframes, the FDA may simultaneously take additional action regarding any other violative products that the company may be marketing, including any other unapproved drugs.

"These unapproved products have put consumers health in jeopardy, from reports of permanent vision loss with unapproved balanced salt solutions to a serious drop in blood pressure and increased heart rate from the topical papain products," said Janet Woodcock, M.D., director for the Center for Drug Evaluation and Research. "Consumers need to be assured that all drug products are manufactured according to the high quality standards required for FDA approval and that they are safe and effective."

About Unapproved Ophthalmic Balanced Salt Solutions (BSS):
Ophthalmic balanced salt solutions are used to irrigate the eye during surgery on the eye, including cataract and other ocular procedures. FDA has received reports of serious injuries to the eye from unapproved ophthalmic BSS. Users of these unapproved products have reported to FDA injuries including eye inflammation, cloudy vision, and permanent loss of visual acuity. Inspection of these products revealed contaminants and other product defects. Thus, FDA urges doctors and others who use these products to switch to approved versions of BSS made by Alcon and Akorn. FDA oversight of the manufacturing of ophthalmic BSS products helps to ensure that they are properly made and to reduce the risk of contamination and associated injuries.

Topical drug ointments containing papain are used to remove dead or contaminated tissue in acute and chronic lesions, such as diabetic ulcers, pressure ulcers, varicose ulcers, and traumatic infected wounds. Trade names for these products include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox. Other products are marketed under the names of the active ingredients, for instance, papain-urea ointment.

The FDA is taking action today against these products because it has received reports of serious adverse events in patients using products containing papain. Reports include hypersensitivity (allergic) reactions that lead to hypotension (low blood pressure) and tachycardia (rapid heart rate). In addition, patients who are allergic to latex can also be allergic to papaya, the source of papain. Therefore, patients with latex sensitivity may be at increased risk of suffering an adverse reaction to a topical papain drug product.

FDA urges consumers who are using topical drug products containing papain, and who have questions or concerns, to contact their health care provider about discontinuing treatment with these products. There are a number of FDA-approved topical products that have been found safe and effective as wound healing agents and that do not contain papain.

"Removing unapproved topical drug products containing papain and unapproved ophthalmic balanced salt solutions is yet another step forward for patient safety," said Deborah M. Autor, director, Office of Compliance for CDER, FDA.

These actions are part of FDA’s unapproved drugs initiative. That initiative seeks to ensure that all drug products marketed in the United States are shown, through the drug approval process, to be safe and effective and to meet appropriate standards for manufacturing and labeling. This represents the eighth and ninth actions taken by the agency against a class of unapproved drugs since issuing a compliance policy guide (CPG) on marketed unapproved drugs in June 2006. The CPG describes FDA’s risk-based enforcement approach to marketed unapproved drugs.

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Falls A Leading Cause Of Injury-Related Emergency Department Visits For Infants Each Year, CDC Study Shows

Half of the estimated 328,500 infants 12 months of age or younger who were treated for injuries in hospital emergency departments each year from 2001 to 2004 were injured as a result of a fall, according to a study by the Centers for Disease Control and Prevention. The first national estimate of infant injury by month of age was published in the May 2008 American Academy of Pediatrics journal, Pediatrics.

Falls were the leading cause of injury for every month during the first year of life. Because the first year of a baby’s life is a time of rapid developmental change, every month brings different injury risks as mobility develops. CDC researchers indicate that each stage of infant development, such as whether a child is crawling or walking, plays a large role in types of injuries.

"Common sense tells us, and research confirms, that injuries among infants take a significant toll," said Ileana Arias, Ph.D., director of CDC′s Injury Center. "As children develop -- in infancy and throughout childhood -- protective factors such as home safety measures and close parental supervision are critical in helping to prevent injuries."

A crucial factor is the child’s developing mobility. Stair-related injuries are an example, leading to treatment for an estimated 5,500 12-month-olds but only 800 1-month-olds.

"When parents are aware of first-year motor milestones and their associated injury risks, they can be better prepared to help predict and prevent their infants from being injured," said Julie Gilchrist, M.D., an author on the study and medical epidemiologist in CDC’s Injury Center.

The findings came from an analysis of data collected from the Consumer Product Safety Commission’s national database on injuries seen in hospital emergency departments

For more information about CDC’s prevention efforts, please link to www.cdc.gov/injury. For a copy of this study, please link to http://pediatrics.aappublications.org/.

Army Aims to Better Identify Soldiers with Brain Injuries

By C. Todd Lopez
Special to American Forces Press Service

An Army report released yesterday outlines how the service can better identify and help soldiers who have suffered traumatic brain injuries.

The report contains some 47 recommendations to help the Army better prevent, screen, diagnose, treat and research traumatic brain injury, said Brig. Gen. Donald Bradshaw, who led the task force charged with investigating TBI. Bradshaw is commander of Southeast Regional Medical Command and Eisenhower Regional Medical Center, at Fort Gordon, Ga.

"Our report indicates that, like our civilian counterparts, the Army has done well in the identifying and treatment of severe or penetrating traumatic brain injury, but is challenged to understand, diagnose and treat personnel who have suffered short-term or persistent symptoms of mild TBI," he said. "The task force identified opportunities for improvement as well as best-practice guidelines."

The general said 80 percent of those who suffer from mild TBI, commonly known as a concussion, recover completely. Some 10 to 20 percent of soldiers and Marines returning from Iraq and Afghanistan with experience in combat may have suffered symptoms consistent with mild TBI.

Today, eight of the recommendations made by the task force have already been implemented, said Col. Judith Ruiz, deputy director for rehabilitation and reintegration with the Office of the Surgeon General.

"We have made significant progress to take care of soldiers and to standardize practices across the Army medical department," she said.

Some of the recommendations that have already been implemented include:

-- Working with interagency and civilian groups to better define TBI;

-- Implementing in-theater TBI screening and documentation for all soldiers exposed to brain injury-inducing trauma;

-- Adding TBI-specific questions to deployment-related health assessments;

-- Developing a proposal on the appropriate functions of a "TBI center of excellence";

-- Proposing the Defense and Veterans Brain Injury Center as the core of the new center of excellence;

-- Optimizing the positioning of clinical, educational and research activities;

-- Centralizing the evaluation of the scientific merit, clinical utility, and priority of new treatment strategies, devices or interventions; and

-- Adapting the Military Acute Concussion Evaluation overprint as an approved Department of the Army form to document mild TBI closest to the point of injury.

Ruiz said 31 additional recommendations are in progress, four are planned, and four are in the process of being transferred to other agencies.

For soldiers in theater, the most common cause of brain injury is a blast, such as from an improvised explosive device. But sometimes such blasts do not cause visible external injuries.

"Brain injury does not have to have outside symptoms, such as bleeding," Bradshaw said. "It may, but doesn't have to. That is one of the compounding things; folks may look totally normal, but be dazed."

Because some victims of IEDs or other blasts do not have external injures, they may feel they have not been injured at all -- even if they did sustain a mild TBI.

"It's hard to identify TBI when soldiers don't come forward and don't identify," Bradshaw said. "Some of the actions that have been taken (include) a very big ongoing education process for leaders, soldiers and family members."

The Army launched the post-traumatic stress disorder/mild traumatic brain injury chain teaching program in 2007 to help soldiers better identify signs and symptoms of these conditions and to reinforce the collective responsibility to take care of each other.

The Army is also working to educate the civilian medical community about mild TBI so that soldiers in the reserve components, who may not have full-time access to military medical care, also can be identified, said Col. (Dr.) Jonathan Jaffin, deputy commander of the U.S. Army Medical Research and Material Command.

"One of the things we are concerned with and ... one of the points behind the whole chain teaching was trying to get the message out to the country, not just the active-duty force, Guard and reserve," he said. "(We wanted) the country, including providers throughout the country, to be aware of mild TBI and concussions and the long-term symptoms that some people may be having."

Bradshaw said Army leaders at all levels are committed to the good health and well-being of all soldiers and are proactively addressing the issue of TBI. "Continued research in this area can only help us more clearly understand the medical impacts of the war and the best ways to prevent, recognize and treat soldiers with TBI," he said.

(C. Todd Lopez works for the Army News Service.)