I just read the JAMA article on pacemaker approval processes and posted an article about it at http://tinyurl.com/ya42spk. This is kind of the Cliff's Notes version of the article, if you care to read it. The article itself is pretty dense and hard to get through unless you like reading a lot of scientific data.

Bottom line: the testing methods used by manufacturers to get pacemakers and ICDs cleared by the FDA could be more scientifically sound.

 

On www. msnbc.com there is an entry for how the FDA does not set success criteria for "devices" - including PMs, stents etc. Here si the link:
http://www.msnbc.msn.com/id/34623228/ns/health-heart_health/
Any thoughts? I am not freaking out but it is concern ...
Thx all
Putnam

 

By Steve Sternberg, USA TODAY

Heart specialists on Monday filed suit against Secretary of Health and Human Services Kathleen Sebelius in an effort to stave off steep Medicare fee cuts for routine office-based procedures such as nuclear stress tests and echocardiograms.

The lawsuit, filed in U.S. District Court for the Southern District of Florida, charges that the government's planned cutbacks will deal a major blow to medical care in the USA, forcing thousands of cardiologists to shutter their offices, sell diagnostic equipment and work for hospitals, which charge more for the same procedures.

"What they've done is basically killed the private practice of cardiology," says Jack Lewin, CEO of the American C...

 

theheart.org sent an article this morning about the US health care reform bill with its tax on cardiac devices and its impact on manufacturers.
http://www.theheart.org/article/1033123.do
You may have to create a membership and log in to see the article, but membership is free and they don't spam you.

p.s. no political discussion!!!! I just found the article interesting and it'll impact many of us

 

More marvels of electronics that await us. Now and the doctor can sit in the doctor's office and sen what your heart is doing, maybe.

General Electric Co. CEO Jeff Immelt, Tuesday gave an audience at the Web 2.0 Summit in San Francisco the first public viewing of the company's new pocket-sized device, dubbed Vscan, that's designed for point-of-care imaging.

Though Immelt couldn't say how much the Vscan will cost, he said he's hoping a much lower price tag than traditional medical imaging machines while getting the technology into the hands of doctors around the world.

"It's the stethoscope of the 21st Century," said Immelt. "It's an ultra sound the same size as a Blackberry with the same power that an ultr...

 

www.centerwatch.com
www.searchclinicaltrials.org
www.clinicaltrials.gov

I recently tried to qualify for a trial for a new drug for A-fib (it was a coumadin replacement) I was turned down after question 4. Which was do you have CHF. The first 3 were are you diabetic? Did you have a heart attack? Do you have high blood pressure, all those answers were no the CHF seemed to be the deal breaker.. I imagine most of us will not qualify for the stringent guidelines they have nor will we want to. But I was interested in a drug other than coumadin.

Respectfully,Denise

 

Carol Kasyjanski, a Glen Cove resident and soft-spoken mother of two adult sons, quietly made medical history a few weeks ago when she became the first heart patient in the nation to receive a new generation of pacemaker with a super-sophisticated surveillance system.

Kasyjanski's pacemaker streams data wirelessly on the health of her heart - and the health of the pacemaker itself - to a monitoring device next to her bed. As she sleeps, the data flow to a central server thousands of miles away in California. Her doctor can tap into the information any time of day or night, from the hospital or even his home.

For the full story please go to www.newsday.com and do a search for Aug. 15, 2009 "pacemaker" That is how I fo...

 

Has anyone else been watching the congressional hearings on defective medical devices on CSPAN? I saw a rerun yesterday and most of it focused around the defective Medtronic ICD leads.

Of course this stuff isn't new. These days almost any corporation will withhold information and action as long as they can. Medtronic only did it for 3 years. How about the defective rudder controls on the 737 jetliner where they just finally finished replacing the last one after the problem first occurred in 1996. Several fatal crashes and several close calls didn't result in grounding the aircraft until it was fixed, and all with the FAA's blessing.

So the next time your ICD starts randomly firing or fails to fire, just be comforted ...

 

This is part of an article on pacemakers/defribillators from our local paper this morning. One sentence (marked with < >) may be of particular interest to our group as the question on this comes up from time to time.

JUMP START FOR HEART DEVICE MAKERS

Heart device makers are hoping innovations and recent clinical trials will pump up sales, leading to faster growth.

Sales of implantable devices that treat problems like heart failure, slow or fast heartbeats and irregular heart rhythms have stagnated in recent years in the wake of product recalls and other issues.

But the companies that make these products are increasingly optimistic that the devices can also help patients with less severe forms...

 

Recently there was some discussion here about the possibility of a heart healing itself to the point where a PM was unnecessary. The following article was published recently by the AP. While it strongly implies the medical community is surprised by the results, as I said before I've read several medical journals showing other cases.

Study: British girl's damaged heart heals itself a decade after doctors give her second heart
07-13-2009 09:40 PM MST |By MARIA CHENG, AP Medical Writer

British doctors designed a radical solution to save a girl with major heart problems in 1995: they implanted a donor heart directly onto her own failing heart.

After 10 years with two blood pumping organs, Hannah Clark's f...

 

Medtronic are reseaching and developing a "GASTRIC PACEMAKER" to be fitted to patients who cant keep their appetites in check. It "PACES" your stomach to make you feel sated. Apparently 15 patients have already been fitted with the device as a medical trial. If they get too thin will they be able to sue? Most likely they will be programmable to adjust your weight to whatever you want. Just think they could be linked to pick up Sat Nav and make you feel sated every time you pass McDonalds. As someone who has had problems with my heart pacemaker also pacing my stomach I dont think it will be too popular. What with the interest in brain pacemakers I cannot help wondering what the end game could be- a three in one pacemaker to keep you hear...

 

FDA NEWS RELEASE
For Immediate Release: July 2, 2009
Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

FDA Approves Multaq to Treat Heart Rhythm Disorder
The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.

Multaq may cause critical adverse reactions, including death, in patients with recent severe heart failure. The drug’s label will contain a boxed warning, th...

 

Just saw this on recall of Medronic PM. Site has a phone # to call for more info.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety
AlertsforHumanMedicalProducts/ucm165711.htm

Janet

 

Heard about this on the 11PM news tonight:

Medtronic link:

http://www.medtronic.com/kappasigma/patient.html
-----
CNNMoney.com story:

Medtronic Inc. (MDT) on Monday sent doctors around the world a letter telling them about potential issues with wires in some older pacemakers that affects about 37,000 devices and may lead doctors to remove and replace some of them.

The issues covered in the "Dear Doctor" letter involves a small fraction of the more than 1.7 million "Kappa" and "Sigma" pacemakers implanted in the last 12 years. The letter included a new problem with both pacemakers and an issue with Sigma devices that was first identified in 2005 but has caused a higher- than-expected fa...

 

I found an interested article at that may interest other members. The full article can be found at www.theheart.org/article/962057.do 

Here are some excerts.

In an analysis of data from the National Cardiovascular Data Registry Implantable Cardioverter Defibrillator (ICD) Registry, investigators showed that ICD implantations by nonelectrophysiologists (non-EPs) are associated with a higher rate of procedural complications and that patients are less likely to receive cardiac resynchronization therapy with defibrillation (CRT-D), when compared with board-certified electrophysiologists (EPs)...

"As far as I know, there are no nationa...

 

Awesome.

http://tinyurl.com/c3u2lq

 

Oh happy day. We will soon be getting a "one size fits all" pill called a polypill. One that contains five medicines, a beta blocker, an ace inhibitor, a diuretic, a statin and aspirin.

Forget the fact that one person's need for different amounts of one of these medicines may differ from that of another person, you are all going to get the same amounts. I say you are all going to get the same amount because old Smitty is not going to take that thing.

I don't care how many trials they have run. I'm sure it has possibilities for simplifying the doctor's work, but I also see it as a good way to increase the business of the undertaker.

One of the reasons I will not take the medicine Plavix...

 

http://health.usnews.com/articles/health/healthday/2009/03/28/new-device-treats-common-heart-rhythm-disorder.html

(Copy & Paste to your Browser)

 

I recently read this article in the National Post and thought I would share it. The idea is so simple, I had just assumed it was automatically being done.

---

Airline pilots have used them for years as a proven method to make flying less dangerous. Now there is evidence that surgical staff can dramatically curb the amount of harm they inadvertently do to patients simply by working through checklists before, during and after operations.

Employing a standard checklist slashes the number of serious complications and deaths from surgery by more than a third, an international study published Wednesday by hospitals in Toronto and seven other cities concluded.

The concept could have a huge impact if in...

 

By Alex Nussbaum
Nov. 10 (Bloomberg) -- A beating heart's excess energy was tapped by British scientists in a first step toward extending the life of batteries that power pacemakers and other medical devices.

A generator inserted into a pig's heart on the tip of a wire produced 4.3 microjoules of electricity, about a fifth the energy needed to fuel a pacemaker and enough to help recharge its battery, researchers said in a study released at the American Heart Association's annual meeting in New Orleans.
Defibrillators and pacemakers are pager-sized devices implanted in the chest to shock faulty hearts back into rhythm. Newer versions track blood oxygen levels, temperature and other data, but advances have been limited...