JIG meets Monday at my house.
Betsy
NOTICE: Unless restricted by law, email correspondence to and from Anoka
County government offices may be public data subject to the Minnesota
Data Practices Act and/or may be disclosed to third parties.
JIG meets Monday night at my house.
Betsy
NOTICE: Unless restricted by law, email correspondence to and from Anoka
County government offices may be public data subject to the Minnesota
Data Practices Act and/or may be disclosed to third parties.
fyi
April 7, 2009
Removing Medtronic Heart Cables Is Hard Choice
By BARRY MEIER
BOSTON . Pulling a medical device off the market is one thing. Removing it from the bodies of thousands of patients is a lot more complicated and dangerous.
Consider the Sprint Fidelis, a heart defibrillator cable. In 2007 its maker, Medtronic, stopped selling it after five patients who had the cables died.
But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country.
In the next few years, thousands of those patients may face risky surgical procedures to remove and replace the electrical cable, which connects a defibrillator to a chamber of the heart.
Medtronic estimates that the cable has failed in a little more than 5 percent of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.
Already, four patients have died during extractions. Experts fear that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of the operations.
.I think we are just seeing the tip of the iceberg,. said Dr. Charles J. Love, a cardiologist at Ohio State University Medical Center in Columbus, who specializes in cable extractions.
For many of the patients around the country who may need the procedure, finding the right medical center will not be easy.
There is little publicly available data on the volumes and success rates of the procedures at the nation.s hospitals. Some hospitals disclose their own numbers, but many more do not.
.There are people who are doing this that don.t meet the criteria,. said Dr. Bruce Wilkoff, a cardiologist at the Cleveland Clinic.
Even experienced cardiologists at well-regarded hospitals, like Dr. Laurence M. Epstein at Brigham and Women.s Hospital here, consider the procedure challenging.
Dr. Epstein recently operated on a patient, a 63-year-old man, whose Sprint Fidelis cable had become so overgrown with tissue that it was stuck inside a major vein.
To free it, Dr. Epstein cautiously threaded a catheter-guided laser through the blood vessel to dissolve the entrapping tissue. It was a risky move. The deaths of the four Sprint Fidelis patients at other hospitals apparently occurred when less practiced doctors damaged a vein or the heart, causing extensive bleeding.
Finally, Dr. Epstein pulled the cable out. .This was one of the more difficult ones,. said Dr. Epstein, who added that he had removed scores of the Sprint Fidelis cables in the last year without a major complication.
It is not unusual for heart cables, or leads as doctors call them, to eventually wear out or fail, which is why there are doctors who specialize in removing them. What makes the Sprint Fidelis situation stand out is the vast number of patients who got the cable before its recall. A quarter-million people around the world received a Sprint Fidelis in the three years from its introduction in 2004 to its recall in October 2007.
The cable.s chief flaw is the tendency for it to crack, creating electrical problems. The defibrillator may fail to give a heart a life-saving jolt to disrupt a potentially fatal rhythm. Or it may repeatedly discharge, shocking patients for no reason.
Also, when a Sprint Fidelis is used with a device that combines a defibrillator with a pacemaker, the cable.s flaw may interfere with the pacemaker.s ability to keep a patient.s heart beating at a steady rhythm.
Medtronic has given patients some guidance about extractions, like telling them to seek a hospital experienced in the procedure if they decide to have a Sprint Fidelis removed. Though the company has declined to indicate which medical centers have such experience, it recently compiled such a list. Last year, to win approval for a new heart cable from the Food and Drug Administration, the company agreed to provide the F.D.A. with future data from .10 experienced extraction centers,. according to agency records. But Medtronic says it does not plan to make such a list public.
.Medtronic believes that a patient.s physician is in the best position to make decisions related to patient care, including the most appropriate lead extraction center,. the company wrote, in response to a reporter.s question.
Experts say patients should ask a hospital how many of the procedures it has performed, and go to medical centers that do at least 50 a year.
Medtronic has been shielded so far from legal claims over the recalled device. More than 1,000 patient lawsuits involving the Sprint Fidelis have been thrown out because of a ruling last year by the Supreme Court. The court held in a ruling involving a different medical device that federal law protects device makers from liability suits involving some products, as long as the F.D.A. has approved their products.
Some Democrats in Congress have vowed to pass legislation that would override the Supreme Court decision. They cite the Sprint Fidelis problem as one reason, also noting the F.D.A. let it onto the market without extensive testing.
Medtronic is supplying replacement cables, but the cost of the operation to implant a cable, which can run $15,000 to $20,000 is being borne by Medicare or private insurers.
A defibrillator cable can last 15 years or more . much longer than a defibrillator, whose built-in batteries may wear out in five years or so. When the cable does eventually wear out, or break, extracting it is not the only option. Often doctors will leave the old one in place, threading a new cable in place alongside.
Those options pose competing risks, experts say. While extracting a cable can be dangerous, leaving it in place can make it more difficult to remove later, because of in-grown tissue.
In the case of the Sprint Fidelis, doctors will be making decisions for a huge number of patients. Medtronic.s recent estimates indicate the cables are likely to stop working in thousands of people in the next few years.
Meanwhile, even tens of thousands of additional patients for whom the Sprint Fidelis is still working will need to undergo a procedure in the next few years to have the defibrillators themselves replaced, as the batteries wear out. During replacement procedures, doctors will need to weigh the risk of hoping the cables continue to work or replacing them.
Medtronic has said that whether the Sprint Fidelis is broken or is still working, it should be extracted only as a last resort. The company said it did not know how many Sprint Fidelis cables have been extracted.
Specialists take different approaches on the matter. Dr. Wilkoff of the Cleveland Clinic said he planned to reattach a working Sprint Fidelis when he replaces a defibrillator. Because of the clinic.s experience in implanting cable, he said, the failure rate at his hospital has been much lower than at other medical centers.
But other experts like Dr. Epstein, who are concerned about the failure rate, have started pre-emptively removing the cables in some patients. That was the approach he took with his 63-year-old patient, whose life depends on the reliable operation of his heart pacemaker.
Dr. Love of Ohio State, meanwhile, said he had begun routinely removing the Sprint Fidelis when changing defibrillators or pacemakers in younger, more active patients . typically those age 60 or less . because greater physical activity places more stress on a cable, raising the likelihood of its fracturing.
The Heart Rhythm Society, a group representing doctors who implant heart devices, plans to issue guidelines about cable extraction this year. They would urge doctors to perform at least 30 removals under the supervision of an experienced extraction surgeon before operating solo.
But some experts say that it is difficult for doctors to obtain that level of training. And they caution that even well trained physicians need to regularly perform significant numbers of extractions to remain proficient.
The group of device experts, which plans to urge doctors to collect more data about defibrillator cables, has not released a list of hospitals experienced in extractions.
Dr. Epstein said that two of his patients had died of complications during the first 200 extractions of various makes of cables he performed. Since then, he said he had performed 800 procedures without any deaths.
.Of all the procedures I do,. he said, .extraction probably has by far the largest learning curve..
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* Dr. James Ellingson, jellings(a)me.umn.edu *
* University of Minnesota, mobile : 651/645-0753 *
* Great Lakes Brewing News, 1569 Laurel Ave., St. Paul, MN 55104 *
I sent by individual e-mails the JIG Schedule K-1s. If you didn't
receive one, let me know. (Peggy - I sent yours to the e-mail address I
have for you at home.)
Betsy
NOTICE: Unless restricted by law, email correspondence to and from Anoka
County government offices may be public data subject to the Minnesota
Data Practices Act and/or may be disclosed to third parties.
I'm canceling the Monday, March 16 JIG meeting since neither John nor
Peggy are available. I have checks from John, Peggy and Maryellen, so
Jim and Al, please send me your checks and I'll send them in for the
month. My address:
Betsy Kremser
1373 Spencer Rd W.
Saint Paul, MN 5518-5206
I will e-mail your Schedule K-1 forms to you no later than Monday. I'm
almost done with them, just have to finish the calculations related to
our sold or merged stocks.
Betsy
NOTICE: Unless restricted by law, email correspondence to and from Anoka
County government offices may be public data subject to the Minnesota
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JIG meets Monday at my place...the usual 6:30 p.m.
Betsy
NOTICE: Unless restricted by law, email correspondence to and from Anoka
County government offices may be public data subject to the Minnesota
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JIG meets tonight at my house.
See you later,
Betsy
NOTICE: Unless restricted by law, email correspondence to and from Anoka
County government offices may be public data subject to the Minnesota
Data Practices Act and/or may be disclosed to third parties.
The holiday party/meeting will be at our home on Monday, December 15th (yes Peter will show up). Spouses, friends, others are all invited. See you then. Call if you need directions. m
Maryellen Skan (612/623-7805)
428 3rd Ave NE, 55413
skanx001(a)usfamily.net
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November 19, 2008
Exchange Rate Hurts Profit at Medtronic
By THE ASSOCIATED PRESS
Medtronic, the medical device maker, said Tuesday that legal expenses and declining foreign exchange rates weighed down its quarterly profit.
The company was also hurt by lower-than-expected sales of pacemakers, spinal implants and other devices.
Shares of Medtronic, which is based in Minneapolis, fell $4.82, or 13 percent, to $31.60.
Earnings for the period, which ended Oct. 24 and was the second quarter of Medtronic.s fiscal year, fell 14 percent, to $571 million, or 51 cents a share, from $666 million, or 58 cents a share, in the period a year earlier.
Sales rose 14 percent, to $3.57 billion from $3.12 billion.
Eliminating $187 million in charges that resulted mainly from a patent dispute over stents with a rival, Johnson & Johnson, the company said it earned 67 cents a share.
.Clearly, this was a tough quarter, and the environment is changed a bit,. the chief executive, Bill Hawkins, told analysts. .We have seen some things that we didn.t anticipate coming about in the last three months or six months..
Sales outside the United States rose 18 percent, to $1.37 billion, helped by a $65 million gain from the weaker dollar. But that gain from currency exchange rates fell by more than half compared with $150 million in the prior quarter.
Medtronic now projects fiscal 2009 revenue of $14.6 billion to $15 billion, down from a previous forecast of $15 billion to $15.5 billion.
Sales from the company.s largest unit, cardiac rhythm management, rose 8 percent, to $1.24 billion, mainly on increased sales of implantable defibrillators.
But analysts focused on lower-than-expected pacemaker sales, which rose 2 percent, to $506 million.
Sales at the company.s cardiovascular business grew by 22 percent, to $596 million.
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* Dr. James Ellingson, jellings(a)me.umn.edu *
* University of Minnesota, mobile : 651/645-0753 *
* Great Lakes Brewing News, 1569 Laurel Ave., St. Paul, MN 55104 *
November 18, 2008
Citi Plans Asset Sales and Job Cuts
By ERIC DASH
The banking giant, Citigroup, which a decade ago set out to rewrite the rules of American finance, announced Monday morning that it would cut 50,000 jobs in the coming quarters, largely by selling assets.
In a town hall meeting with employees, the bank also said that it was seeking to shore up its capital base and cut risky positions. In addition, the bank said that it would trim expenses by 16 percent to 19 percent to about $50 billion in 2009.
The job cuts would be in addition to about 23,000 layoffs already this year. Most of the layoffs would come through attrition of the sale of units, the bank said, meaning the actual number of layoffs could be less at the bank. The cuts would leave the bank with about 300,000 employees, down from its peak of about 375,000 in the fourth quarter of last year.
While the cuts will come across the company, investment bankers are expected to bear the brunt of the loses because senior managers have been asked to reduce expenses significantly. But back-office functions, like the bank.s legal and human resources divisions, are also expected to be hard hit.
Once the most valuable financial company in America, Citigroup is withering along with its share price, which sank into single digits for the first time in a dozen years.
As Vikram S. Pandit completes his first year as chief executive, many analysts say Citigroup has lost its way. Insiders say the company is racked by office politics at a critical moment in its history.
Mr. Pandit is struggling to regain his grip on the company, which operates in scores of countries, after his attempt to buy Wachovia was upended by Wells Fargo. That misstep left Citigroup grasping for a new strategy to lure deposits and build up its branch network in the United States.
Citigroup is also grappling with how to position its domestic consumer business, which faces rising loan losses and, analysts say, lacks the leadership and strategy it needs. Having lost Wachovia, Citigroup must now try to stitch together a group of small regional banks to catch up with Bank of America, JPMorgan Chase and Wells Fargo. Executives are looking at Chevy Chase Bank, a small lender in Maryland with $14 billion in assets, among several other institutions, according to people close to the situation.
But assembling a large franchise could take years, and digesting deals has never been one of Citigroup.s strengths.
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* Dr. James Ellingson, jellings(a)me.umn.edu *
* University of Minnesota, mobile : 651/645-0753 *
* Great Lakes Brewing News, 1569 Laurel Ave., St. Paul, MN 55104 *
