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Bengster, do you know how long it takes for approval of IDEs? It appears to me that DEVAX applied in April 2007 and XTENT in Sept 2007 but till now, FDA has not even approved these two applications yet. Actually the strategy of getting XTENT to apply for IDE and get their large trial of about 2500 people going and eventually leading to FDA approval is quite good. This way, BIG does not have to burn cash.. and perhaps ride on XTENT's results to get FDA approval. Not sure if this can happen..?
Read somewhere that XTENT should expect reply from their CE application in May 2008. So hope this is +ve..
First clinical data on "healing" stents hint at reduced stent thrombosis, but also increased restenosis
Barcelona, Spain - Physicians at this year's EuroPCR meeting had the chance to glimpse some of the first randomized clinical data on so-called "active" stents that promote vessel healing while reducing the risk of antiproliferative reactions, without carrying polymers or drugs that have been blamed for an increased risk of stent thrombosis.
Whether such stents end up competing directly with blockbuster drug-eluting stents (DES) or end up as niche products in people who cannot take dual antiplatelet therapy remains to be seen, experts say.
The Genous stent is an antibody-coated bare-metal stent designed to capture a patient's own endothelial progenitor cells (EPCs) to accelerate the natural healing process after stent placement and to modulate smooth-muscle-cell growth. Stent developers believe the stent would be particularly attractive to patients who cannot take extended dual antiplatelet therapy or who may be at particularly high risk for stent thrombosis.
Investigators for the e-Healing multicenter first-in-human registry of the Genous stent (OrbusNeich) and for the TRIAS-HR randomized pilot study comparing the Genous stent with the Taxus stent presented new data here at the meeting. The e-Healing registry, led by Dr Sigmund Silber (Dr Müller Hospital, Munich, Germany) and Dr Robbert de Winter (Academic Medical Center, Amsterdam, the Netherlands) had, as of late March 2008, enrolled almost 5000 patients at 144 sites. In an interim analysis of 1640 patients who have completed 12-month follow-up, investigators report that rates of cardiac death, MI, and target lesion revascularization (TLR) are low and comparable with rates seen in the early Taxus registry studies. Importantly, a low rate of stent thrombosis was seen despite patients taking just one month of dual antiplatelet therapy.
e-Healing registry: 12-month results
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End point
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12 mo (%)
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Cardiac death
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2.1
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MI
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1.8
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TLR
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5.4
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|
MACE
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9.3
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Stent thrombosis
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1
|
|
OK, no penalty kick, chiong all the way. Cheers.
ObusNeich's Genous stent. New competitor but i think no match to BIG.
http://www.theheart.org/article/866905.do
*** Taxus DES can really write off liao. Funny thing is why is Taxus still the best selling DES? I tell you BSX is a very high hand in connections with hospitals and doctors. Doctors always want to recommend Taxus and claim "Taxus has the track record". I shot back at a Chao Bayi Cardiologist: Track record for what? Deaths???" Nar Bei! Taxus DES is selling very very expensive man. Many patients duno what and why they are paying so much for this standard of performance.
Now we can see that Cypher is a better performer than Taxus. Biomatrix will take on Cypher in LEADERS and prove to the world Biomatrix is in First Class Honours category. What Endeavor DES cannot do in Endeavor III RCT, BIG will show Medtronic how to do it: "How to kill a JNJ DES".
http://www.theheart.org/article/866143.do
yupe. anyway, the price movement is just a matter of time... I think many people are watching sideline now until the results is out next week.. even though we expected there would be loss in operation,.
jasonrxz ( Date: 16-May-2008 17:09) Posted:
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Bro JJ,
No harm trying or listen to him..... If so coincidence tat the price move according to pattern then is good.... If din move, we had nothing to lose right???? hee
But I also think that there is nothing about so call 'pattern" especially in stocks.....We shall see and monitor closely next week which is short by one day ( 4 trading day only).
Let's hope the assumption is correct... chiong ar!!!!!
jackjames ( Date: 16-May-2008 16:57) Posted:
| waaa.... like that also can ? |
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Newer-generation DES: promising two-year results vs Taxus for Xience V and Nobori
Barcelona, Spain - Longer-term results for the so-called "next-generation" drug-eluting stents (DES) are trickling in, offering the hope that newer polymers, drugs, or stent designs represent a true improvement over first-generation DES. Two-year results for the Xience V stent in the
SPIRIT III study and for the Nobori stent in the
NOBORI I and
II trials suggest that the newer stents may be superior to the Taxus stent.
Two-year follow-up for both trials was presented here at the EuroPCR 2008 meeting.
Presenting the two-year results for SPIRT III, Dr Gregg Stone (Columbia University, New York, NY) showed that the gap separating MACE and target-vessel-failure (TVF) rates in patients treated with the everolimus-eluting Xience V stent vs the paclitaxel-eluting Taxus stent has continued to widen between 12 and 24 months, favoring the Xience everolimus-eluting stent. One-year results for the study, recently published in the Journal of the American Medical Association [1], suggested that the newer device was statistically superior to the Taxus for MACE, but for TVF (any cardiac events in the treated vessel) showed only a trend in favor of the Xience V. But at two years, the difference between the groups was statistically significant, Stone reported Tuesday. MACE rates were reduced by 45%, while TVF was reduced by 32%. Rates of target lesion revascularization (TLR) and stent thrombosis were also numerically lower for the Xience V stent.Two-year clinical results for SPIRIT III
End point
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Xience V, n=669 (%)
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Taxus, n=333 (%)
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p
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MACE
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7.3
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12.8
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0.004
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TVF
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10.7
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15.4
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0.04
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TLR
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4.6
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7.5
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0.07
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Definite/probable stent thrombosis
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0.3
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1.0
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NS
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Further probing of the MACE end point showed that while death and cardiac death rates were not significantly different between the two groups, MI rates showed a strong trend in favor of the Xience V, and all-cause death/MI events combined just reached statistical significance, again favoring the Xience V. The trial was not, however, powered to demonstrate a difference in clinical events, Stone clarified.
Intriguingly, an analysis of stent-thrombosis rates for both stents, based on timing of dual antiplatelet therapy discontinuation, suggested that there were fewer stent thrombosis "episodes" after six months in Xience V-treated patients who had discontinued their meds than in Taxus-treated patients who had stopped dual antiplatelet therapy. The observation "is potentially important and deserves further study," Stone commented.
Available in Europe since early 2006, the Xience V stent received the thumbs-up from an FDA advisory panel last year but has not yet been granted marketing approval in the US.
Nobori results
Dr Bernard Chevalier (Centre Cardiologique du Nord, Saint-Denis, France) presented late results for the phase 1 and 2 NOBORI study of Terumo's stent by the same name. The Nobori stent uses the S-stent platform, a biodegradable polymer, and Biolimus A9; the device received CE Mark approval in Europe earlier this year. In the phase 1 study, the Nobori was compared with the Taxus Express stent, while in phase 2, the comparator stent was the Taxus Liberté; two-year data were available only for the 85 Nobori-treated patients/35 Taxus-treated patients in the phase 1 study.
According to Chevalier, the NOBORI I trial met its clinical end point of noninferiority in terms of in-stent late loss in both phase 1 and 2 of the study, with most angiographic results at nine months showing statistical superiority of the Nobori stent. Although the numbers of patients and events at two years were too small to be statistically meaningful, the rates of TLR and TVF were numerically lower in the Nobori-treated patients. Of note, there were no stent thromboses out to two years for the Nobori stent, despite the fact that only 25% of patients remained on dual antiplatelet therapy at this time.Two-year clinical results for NOBORI
End point
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Nobori (%)
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Taxus (%)
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MACE
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12.9
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22.9
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TVF
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5.9
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11.4
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Clinically driven TLR
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0
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0
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To download tables as slides, click on slide logo below
Discussing the results following their presentation, Dr Evelyn Regar (Erasmus Medical Center, Rotterdam, the Netherlands) suggested that the next-generation DES seem to be, albeit at an early stage, superior to their predecessors. "The new-generation DES, Nobori and Xience V, showed sustained efficacy and safety results over two-year follow-up and proved superior in their respective primary trial end points," she said. While the trend favoring reduced stent thrombosis for the newer stents in both trials is "reassuring," Regar reminded the audience that none of the trials to date have been powered to address the question of stent thrombosis.
Neck quite long alrdy, hope to be shorten next week with all the blessing. Cheers.
Bro JJ,
No harm trying or listen to him..... If so coincidence tat the price move according to pattern then is good.... If din move, we had nothing to lose right???? hee
But I also think that there is nothing about so call 'pattern" especially in stocks.....We shall see and monitor closely next week which is short by one day ( 4 trading day only).
Let's hope the assumption is correct... chiong ar!!!!!
jackjames ( Date: 16-May-2008 16:57) Posted:
| waaa.... like that also can ? |
|
waaa.... like that also can ?
Based on price pattern, the share price will surge every 6-8weeks. The next round should happen anytime next week.
Taken from Biosensor's web site...
Recording of symposium held yesterday, 15 May 2008, in Barcelona in conjunction to Euro PCR 2008.
This symposium entitled "Are drug-eluting stents using biodegradable technology safer than durable coatings?" featured presentations by several leading international cardiologists on the latest on drug-eluting stents, including a discussion on the advantages of biodegradable polymer drug-eluting stents.
http://www.europcronline.com/webcasts/2008/webcast_biosensors/
You can navigate to the different speaker's speeches by clicking on the Chapters button. I would advice those that are considering to accumulate this stock to follow talks from the first and fourth speaker... to see what BIG's technology has to offer. To those that are vested long term.... Viva La Biosensor!!
- Note that LEADERS trial results may be presented in ESC 2008, which is starting on 30th Aug 2008....slightly earlier than TCT 2008 in mid Oct .
- Also look out for OCT technology based scanning (much clearer imaging) results to show better performance of Biomatrix Stent during Leaders results release..
COMING very soon!!!!!!!!!!!!!!!!!!!
Always a calm sea before a big storm. Wait for lightning flashes. Fundamentals improve significantly but share price got even lower. This situation may last a while but not forever. Be patient.
This counter seems to be dying........Does anyone know what is happening?
It seems to me like they are not doing a good job on their branding even though their product is so great.....Sigh.........
this stock is losing steam for too long, guess BBs out of it liao, maybe time to look at other counters.
Can private message to fellow forumers leh. Go to "My Corner" on the top green colour strip. Then go the "My Message" box. Quite fun leh. Check it out!
Newer Generation DES: Promising Two Year Results vs Taxus For Xience V and Nobori
http://www.medscape.com/viewarticle/574485
May 14, 2008 (
Barcelona, Spain) - Longer-term results for the so-called "next-generation" drug-eluting stents (DES) are trickling in, offering the hope that newer polymers, drugs, or stent designs represent a true improvement over first-generation DES. Two-year results for the Xience V stent in the
SPIRIT III study and for the Nobori stent in the
NOBORI I and
II trials suggest that the newer stents may be superior to the Taxus stent.
Two-year follow-up for both trials was presented here at the
EuroPCR 2008 meeting.
Nobori Results
Dr Bernard Chevalier (Centre Cardiologique du Nord, Saint-Denis, France) presented late results for the phase 1 and 2 NOBORI study of Terumo's stent by the same name. The Nobori stent uses the S-stent platform, a biodegradable polymer, and Biolimus A9; the device received
CE Mark approval in Europe earlier this year. In the phase 1 study, the Nobori was compared with the Taxus Express stent, while in phase 2, the comparator stent was the Taxus Liberté; two-year data were available only for the 85 Nobori-treated patients/35 Taxus-treated patients in the phase 1 study.
According to Chevalier, the NOBORI I trial met its clinical end point of noninferiority in terms of in-stent late loss in both phase 1 and 2 of the study, with most angiographic results at nine months showing statistical superiority of the Nobori stent. Although the numbers of patients and events at two years were too small to be statistically meaningful, the rates of TLR and TVF were numerically lower in the Nobori-treated patients. Of note, there were no stent thromboses out to two years for the Nobori stent, despite the fact that only 25% of patients remained on dual antiplatelet therapy at this time.
Two-Year Clinical Results for NOBORI
| End Point |
Nobori (%) |
Taxus (%) |
| MACE |
12.9 |
22.9 |
| TVF |
5.9 |
11.4 |
| Clinically driven TLR |
0 |
0 |
Discussing the results following their presentation,
Dr Evelyn Regar (Erasmus Medical Center, Rotterdam, the Netherlands) suggested that the next-generation DES seem to be, albeit at an early stage, superior to their predecessors. "The new-generation DES, Nobori and Xience V, showed sustained efficacy and safety results over two-year follow-up and proved superior in their respective primary trial end points," she said. While the trend favoring reduced stent thrombosis for the newer stents in both trials is "reassuring," Regar reminded the audience that none of the trials to date have been powered to address the question of stent thrombosis.
