In an unprecedented move, eight medical companies are collaborating to initiate a $100 million study to understand how to best protect heart patients from rare but dangerous clots following heart stent implantation.  The study is intended to take four years and include 20,000 patients. Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages to restore blood flow and relieve chest pain.

The study will be looking at whether heart stent patients can safely be removed from aggressive blood-thinning treatment after one year, or if such patients would be better served by remaining on the medication for at least two and a-half years following implantation with a stent.  Today, guidelines mandate that those patients implanted with drug-coated stents remain on the medication for no less than one year. (more…)

The Associated Press (AP) is reporting on a prominent Chicago surgeon earning royalties on a new heart device he implanted in a 41-year-old woman without her consent; this, according to a lawsuit filed by patient Toni Vlahoulis.  Dr. Patrick McCarthy claims he donates the royalties to charity.

Vlahoulis underwent a second surgery to remove the device because of inflammation and may require a heart transplant, Vlahoulis claims and her cardiologist confirmed.  “There’s no way I would have consented to putting an experimental device in my body,” Vlahoulis said.  McCarthy denies the device was experimental.  Vlahoulis claims McCarthy neglected to inform her he invented the device before the surgery to repair a leaky heart valve in April 2006.  Vlahous’ negligence lawsuit, filed in April 2008, seeks over $50,000 in damages from McCarthy; Chicago’s Northwestern Memorial Hospital; and Irvine, California-based device manufacturer Edwards Lifesciences. (more…)

Two new studies report that cardiac patients may fare better by receiving fewer artery-opening stents and that stents tend to be used arbitrarily. Both studies focused on how to treat patients with clogged arteries, a condition known as ischemia, in which patients develop chest pains when blood flow to the heart’s muscle is blocked.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages to restore blood flow and relieve chest pain. The studies’ findings may lead to more careful placement and less use of stents. According to one study—known as FAME—decreased stent implantation could reduce deaths, heart attacks, and repeated surgeries. FAME results were presented at the annual Transcatheter Cardiovascular Therapeutics meeting of cardiologists and medical-device manufacturers. (more…)

Late last week, Boston Scientific Corporation announced that U.S. health regulators approved the next-generation version of its widely used Taxus drug-coated stent.  Boston Scientifc plans to begin selling the stent in early November.

Meanwhile, in March, Boston Scientific received an approvable letter from the Food and Drug Administration (FDA) for the stent, the Taxus Liberte.  Receiving an approvable letter indicates that certain conditions must be met before full FDA approval is granted.  The company also received a corporate warning letter from the FDA in 2006. (more…)

Laboratory Corp of America (LabCorp) is in violation of the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said yesterday.  LabCorp’s OvaSure test does not fall in a category in which it can be sold without prior clearance from the agency, the U.S. Food and Drug Administration (FDA) said.

“Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,” the FDA said in a September 29 letter.  The FDA also told LabCorp to “take prompt action to correct these violations.”  LabCorp spokesman Eric Lindblom said the company was “disappointed” by the letter.  “We are currently in discussions with the FDA over the next steps and of course we share the FDA’s determination to assure patients are protected,” he said. (more…)

A surprising number of people who receive artificial hips and knees will need to have their joints replaced, according to a recently-released study.  What’s more, another study has found that there is no way to predict what kind of activities might put too much wear and tear on a new hip or knee implant.

Knee and hip replacement surgery has become wildly popular.  According to the Associated Press, Americans undergo 478,000 knee replacements and 234,000 hip replacements every year.  But by 2030, hip replacements are expected to double, and knee replacements are expected to reach a whopping 3.4 million per year.   (more…)

A magnetic resonance device made by Nebion, LLC of California is subject to a Class I recall.  According to the Food & Drug Administration (FDA), the Nebion HLX-8 Magnetic Resonance Device was not approved by the agency, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.

The Nebion HLX-8 Magnetic Resonance Device affected by this recall was manufactured between December 25, 2006 through June 11, 2008, and distributed from June 1, 2007 through June 11, 2008.  Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. (more…)

Medtonic’s Infuse Bone Graft device is now the subject of a congressional probe.  Off-label use of Infuse Bone Graft has linked to life-threatening complications, and lawmakers want to know if Medtronic paid consulting fees to spine doctors to encourage use of the device in unapproved procedures. While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufacturers like Medtronic to actively promote such uses.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.   (more…)

It seems that some large furniture such as TVs, chests, armoires, and appliances can tip over and crush children, causing injury or death.  Last year, the Consumer Product Safety Commission (CPSC) identified this tipping problem as one of the “top five hidden home hazards” and a new data report from CPSC staff reveals that at least 180 tip-over related deaths occurred between 2000 and 2006, with 80 percent involving children under the age of 10. The CPSC report also indicates that between 2005 and 2006 there were at least 40 reports of television or television and furniture related such tip-over deaths.

The reported deaths and injuries tend to occur when children climb onto, fall against, or pull themselves up on television stands, shelves, bookcases, dressers, desks, chests, and stove oven doors.  Likewise, televisions placed on top of furniture can tip over and cause a child to suffer traumatic and sometimes fatal injuries.  “Tip-over related deaths continue to be a problem.  These tragedies can be prevented by taking precautions,” said Acting Chairman Nancy Nord.  To prevent these tragedies, the CPSC recommends the following steps: (more…)

A defective Medtronic catheter used in the company’s implantable intrathecal pain pumps has been linked to the death of one patient.  In June, the company alerted doctors to the problem, but now, the Food & Drug Administration (FDA) has classified  Medtronic’s catheter safety alert a Class I recall.  Such a recall is defined as a situation in which there is a reasonable probability that the use of the product will cause injury or death.

Medtronic’s intrathecal drug delivery systems consist of an implantable pump and catheter that deliver small quantities of drug directly into the intrathecal space in the spine.  These devices are used to treat chronic, intractable pain and for the management of severe spasticity of cerebral or spinal origin. The Medtronic catheter recall involves the following models:  INDURA 1P Intrathecal Catheter, model 8709SC, Intrathecal Catheter, model 8731SC, Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC.   (more…)