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  • CarltheCaddy CarltheCaddy Feb 16, 2001 2:41 PM Flag

    Drug Coated Stents

    I am out of the plumbing side of the business.

    I am hearing alot of conflicting reports on the drug coated stent platforms.

    Can anyone let me know if any of these statements are true.

    Cordis's short term European data looks good, but the "long term" data looks bad? I realize good and bad are realative terms.

    BSC stent data does not look good, due primarily to the fact that the stent is just floating in space. The taxol wound does not heal and the stent basically floats in a mess of goo.

    Thanks in advance.

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    • Ask your doctor about this study:

      Doubling Statin Dose Keeps Arteries Clear
      By Edward Edelson
      HealthScout Reporter

      FRIDAY, Feb. 23 (HealthScout) -- Getting really aggressive with cholesterol-lowering drug treatment -- doubling the dose -- has an impressive effect on keeping arteries clear in people with an inherited tendency to high cholesterol levels, Dutch cardiologists report.

      It's too early to say whether the same aggressive strategy will be beneficial for everyone with high cholesterol levels, says Dr. Anton Stalenhoef, professor of medicine at the University Medical Center Nijmegen, leader of the group reporting a trial in the Feb. 24 issue of The Lancet, but he adds that "this trial is at least in favor of that approach."

      The trial included 325 persons with abnormally high cholesterol levels caused by familial hypercholesterolemia, a genetic condition that puts patients at high risk of heart attack and stroke. All were treated with statins, members of a family of drugs that lower cholesterol levels. Half got the standard dose, 40 milligrams a day, and half were given 80 milligrams a day. The effect of the treatment was assessed by periodic ultrasound examinations that looked for the thickening of artery walls that could eventually block blood flow and cause a heart attack or stroke.

      Over two years, the artery walls of the patients getting the lower dose became thicker, while the artery walls of the double-dose patients became thinner. Side effects were not a problem, Stalenhoef says: "We have seen very limited numbers of side effects in two years with the high doses. There was no significant difference compared with the conventional doses."

      Several trials under way

      The results could be extrapolated to the general population of persons with high cholesterol levels, he says, "but we need definite answers to that question." The answers could come from a number of trials under way in the United States and Europe, Stalenhoef says.

      A number of large-scale trials are in progress, says Dr. Bryan Brewer, chief of the molecular disease branch at the National Heart, Lung and Blood Institute, and they are using statin doses up to 80 milligrams a day. The major issue is whether increasing the statin dose to achieve a major reduction in blood levels of LDL cholesterol, the "bad" kind that clogs arteries, will lower the incidence of heart attack and stroke.

      The current guidelines set a goal of no more than 100 milligrams of LDL cholesterol per 100 deciliters of blood. "There is growing interest in lowering LDL levels to the range of 75 or 80," Brewer says. "The question is whether that would be beneficial."

      Several studies are sponsored by pharmaceutical companies. For example, the TNT (Treating to New Targets) trial, sponsored by Pfizer, is enrolling 8,600 patients who will get statin doses up to 80 milligrams a day. Another trial will give 12,000 patients doses of simvastatin ranging from 20 to 80 milligrams a day.

      The benefits of reduced LDL cholesterol start to decrease as the levels become lower, Stalenhoef says. "We need to find out when the curve becomes flat," he says.

      What To Do

      The trial results favor aggressive statin treatment not only for persons with familial hypercholesterolemia but also for "several categories of patients who have a very high risk of heart disease," Stalenhoef says. "These would include persons with Type II diabetes and, last but not least, patients who already manifest cardiovascular disease."

      But statins aren't for everyone, especially pregnant women and people with liver problems, so talk to your doctor.

      To learn more about statins, try the University of California at Davis or the Heart Information Network.

    • I am a 15 year veteran of heart disease, and some of what I have learned may be useful to you.

      l) Learn all you can. One of my hospitals had a nurse educator who helped me more than any of the physicians--she was willing to answer questions, and to help me figure out what I needed to know. Find that kind of person. Some cardiologists are great at communication--most heart surgeons are surgeons--not a communicative breed--but maybe you can find a listening and talking physician. Mine has spent more time telling me his troubles than I have spent telling him mine, but he does at this point feel to me like a real friend.

      2) Get into the best hospital you can--Hopkins and Harvard cost no more than your local community hospital, and the care is far more sophisticated.

      3) He has got to consider some life changes, like finding a less stressful way to make a living and giving up smoking. You cannot make such decisions for him, but you can support him in trying to make them.

      4) Cheney is not a good model. He has tremendous responsibilities, but he jumped right back into them. Good for the country, probably, but also probably not good for him. He needs to go back to Wilson, Wyoming once in a while, and do some fishing on Fish Creek, which runs right through the town. His heart needs rest, and he needs mild, pleasant exercise.

      5) Stay tuned. There are several health professionals on this board, including some guys who install stents, and their advice is likely to be good.

      6) Take care of yourself. This is a stressful time for both of you. You need to get your rest too, and it is hard for you to do restful things when you are worried. Do them anyway, and pat yourself on the back for staying in training for the task you have to do.

    • I'm very new to using this way of communicating, but I am trying to research the new stents. My husband had a heart attack, Feb.2000 (first one, no heart disease in family), he then had a quadruple bypass, within a month, 2 of the bypasses failed, so they started bypassing the bypasses with stents. Over the past year, the third bypass graft failed, and he now has a total of 9 stents, just from Feb. 00 to Feb. 01. He was 50 when he had the heart attack, and will soon be 51 (law enforcment for a living and smoking). WHAT CAN BE DONE DIFFERENT ????
      I obviously am not a Dr., just a wife that wants to know how to help my husband. He has been in the hospital at least one time every month, going to the cath lab. I sure hope our VP isn't going to have the same problem. I need some direction from someone, anyone (Dr.) that could help. Thanks

    • THE GUVERNOR>>>twoannoyedusa

      In reply to your following statement...

      'Twobob, are you sure you don't have a more active role within Biocompatibles? You seem to take some questions a lot more personally than some ordinary casual investor. Your knowledge and connections within the industry lead me to believe otherwise.'

      I can tell you that twobobuk is most definitely only a very interested investor in Biocompatibles and nothing else. I have met him at a variety of meetings in the UK and can personally vouch for his integrity.

      Biocompatibles are most definitely aware of his presence, and have been for a while now, as he has virtually become their entire PR effort almost single handedly (and totally free of charge!). But there is absolutely no way there is any improper relationship between him and the company. Biocompatibles are infuriatingly conservative in their relations with their investors and do everything strictly by the book. In fact their excessive conservatism is a widely held criticism of the company by many UK investors.

      I first became aware of 2bobuk's interest in Biocompatibles around the time I intruded on your BSX board to start telling you about the company. The reason I personally chose the BSX board was due to the fact that Biocompatibles had a research collaboration with BSX and I also felt that Biocompatibles would be better understood in the USA where they already have a medical devices industry which is widely researched unlike the embarrassingly immature sector within the UK (I was accused by the then residents of merely 'spamming').

      Within that time, I have watched as twobob slowly developed from just an ordinary investor into the most knowledgable poster on this or any other bulletin board. He has done it through sheer effort and I think your insinuations are a little below the belt.

      Should he take your comment...'Your knowledge and connections within the industry lead me to believe otherwise.' as a grudging compliment?

      Anyway, we shall know more about Biocompatibles and the effect they will have on the US stent market soon as they will be distributed there shortly through their partnership with Abbott Labs.

      I think any fair minded observer should start to believe that there could just be something in the story as it is not every day that you get a new entrant in the US stent market from Europe, surely?

      I personally have found the exchanges on this board interesting and very informative and twobobuk has certainly played his part.

      THE GUVERNOR!

    • "A 10% restenosis rate is hardly a failure. I'm not sure what the typical rates for this uncoated device are but I believe that a statistical improvement has been delivered."

      JNJ could claim that the 10% figure you quote is a big reduction on current restenosis rates of 15-20%. But don't forget that JNJ may have used intravascular ultrasound to gain optimum stent placement. So it would make sense to compare the 10% rapamycin coated stent restenosis rate you speculate about with the 8.3% restenosis rate found in the MUSIC trial using the Palmaz-Schatz stent. Now if that sort of comparison was made then the data would suggest that rapamycin gave no benefit what so ever. Lets wait and see.


      "I'm curious, how are you so sure the coating is causing the problems?"

      This is one year follow up we are talking about. The drug elutes from the stent in a maximum 30 days. There were no reported problems at 4 months so problems now must be late stage effects. The finger of suspicion has to look at the coating on the stent because that should be the only thing left in the artery.

      "This can't be verified without removing the stent."

      Not the human ones but what about the animal ones?

      "Do you think Cordis would use a material without a biocompatibility history?"

      Looks like may be they have.

      "I'm not familiar with the Canadian market. Is the Biocompatibles stent mounted on an RX or OTW platform there?"

      Got me with that one. If I was on the inside I would know the answer.

      "Why does the healthcare system there favor your stent?"
      Small vessel stent (2.00mm) sells well and the distributor is excellent.

      "What are Biocompatible's prospects in the US with a strictly OTW platform?"

      Abbott think it worth investing in and they don't move into a new market to be last. They intend to lead.

      "Does the successful Cordis lawsuits against BSX and MDT apply to your stent?"
      No action so far because it is not on sale yet. Abbott will have done their DD. But BCTBF might have to swap a licence on PC for some patents. Who knows?

      "The only thing I heard about the PC/BSX graft was that it didn't live up to expectations. I don't know much about grafts."

      So the claim that PC did not perform is bollox. That saves me digging out a paper rebutting the claim.

      "Twobob, are you sure you don't have a more active role within Biocompatibles? "

      Private investor. Not on the payroll. Just a dog chasing a hare.

      A musical link for you:-

      http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9
      740343&dopt=Abstract


      Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study)

      de Jaegere P, Mudra H, Figulla H, Almagor Y, Doucet S, Penn I, Colombo A, Hamm C, Bartorelli A, Rothman M, Nobuyoshi M, Yamaguchi T, Voudris V, DiMario C, Makovski S, Hausmann D, Rowe S, Rabinovich S, Sunamura M, van Es G

    • Thank you for your response.

      This is good information and the specifics give it credibility. So three patents out of 30 showed signs of restenosis. A 10% restenosis rate is hardly a failure. I'm not sure what the typical rates for this uncoated device are but I believe that a statistical improvement has been delivered. I'm sure the FDA is not going to have a problem with this just because they didn't get 0%.

      I'm curious, how are you so sure the coating is causing the problems? This can't be verified without removing the stent. Do you think Cordis would use a material without a biocompatibility history?

      I'm not familiar with the Canadian market. Is the Biocompatibles stent mounted on an RX or OTW platform there? Why does the healthcare system there favor your stent? What are Biocompatible's prospects in the US with a strictly OTW platform? Does the successful Cordis lawsuits against BSX and MDT apply to your stent?


      Sorry about the foot and mouth comment. That was my weak attempt at humor. The only thing I heard about the PC/BSX graft was that it didn't live up to expectations. I don't know much about grafts.

      Twobob, are you sure you don't have a more active role within Biocompatibles? You seem to take some questions a lot more personally than some ordinary casual investor. Your knowledge and connections within the industry lead me to believe otherwise.

    • Thanks for the response twoannoyedusa

      To follow up there is no wishing required on my part just need to sit back and wait for confirmation that they found three cases of restenosis in the patients examined a couple of weeks back.

      40,000 HUMAN patients have been implanted with PC coated coronary stents over the last three years so there is plenty of live case safety data walking about. BTW Market share currently 25% in Canada for the PC coated stent.

      Not sure what to make of your hoof and mouth disease jibe about the Boston graft because hoof(foot) and mouth is so rare in the UK it has not been seen for decades but now we have an outbreak and thousands and thousands of animals are burning on pyres at this very moment. Are you saying the PC coating is so safe, practically no animals died or thousand were put to death by a Boston PC coated stent graft? Perhaps it is easier to say what you know? Are you sure the graft was any good? PC is good but it can't change base metal into gold.

      JNJ and Boston will both rue the day they didn't take the PC polymer coating when they had the chance.

    • Wishing it were true doesn't make them that way. If I were to take you at your word BSX would have been using your PC coating on their grafts by now. Speaking of which, a while back I got hit by a cold draft from the pacific northwest that said PC coated grafts were taking out more animals than hoof and mouth disease. I guess your miracle polymer is showing a few chinks in the armor as well.

    • "Since when does a "breeze from Brazil" qualify as big news"

      When it's true.

      "especially coming from the Biocompatibles rumor mill?"

      Just a humble investor seeking the truth.

      "How about a link or article"

      Sorry to disappoint but a couple of weeks after the patients have been examined is not enough time to get a peer reviewed article into print and on the web for you to read. Why would JNJ/Cordis rush that into print in a PR Newswire article? More likely to try and keep that news secret. Perhaps you could ask Cordis to deny the story?

    • Thanks for the news and views. I have a further comment to this statement:

      "BTW I think, if you recall BSX spent a lot of time on dosing so as to get it right."

      Yes they did, but the dosing trials were initially in animals weren't they. So will they be right in humans? If they have struck lucky they will find out in the phase I trial that they have the correct dose for human coronary arteries. If not it's onto phase II with an optimised dose. More time more delays.

      But what about the coating which is the most important part. It's the bit that stays in the body years after the drug has gone. How good is that?

      I'll surprise you again and not mention the "B" word. :-)) This just happens to be one of the best boards to discuss stent drug delivery.

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