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Although the Nobori DES and the Biomatrix DES is not designed for bifurcation lesions, both of them are often used for bifurcation lesions, due to the fact that there is NO APPROVED bifurcation DES in the mkt, ( the Devax was CE approved only recently and not yet launched commercially).
In fact, both the Nobori an Biomatrix showed good results for bifurcatio lesions, as their design is open-cell and physicians can often treat the side branch lesions when needed as compared to other DES.
For info.
chim....how come u guys know so much abt these medical terms? u all in this industry?
Thankyou, I got confused by their website's mention of bifurcation lesions see below quotes. Any word on why stock trending up?
" Treating Bifurcation lesions – technical challenges
- Side branch access
- Side branch occlusion
- Optimal carina scaffolding
- Stent thrombosis
- Restenosis
Nobori® stent: technical solutions for treatment of bifurcation lesions"
The Bifurcation stent is known as the Devax DES, and Terumo does not have a license agreement to mkt it. It is also not authorised for sale in Japan, as a separate approval is needed, just like the Nobori DES.
For info.
could this announcement be referring to the Nobori bifurification stent i.e. the BIG stent purchased recently?
Note the trail date will begin in May 2011 - and based on NOBORI's stent. There will be 3200 enrolled. The assumptuion is that approval will be obtained before May.
The Kyoto University statement on the trial speaks of the Nobori DES as " the newly-approved biolimus-eluting stent" and also as " which is going to be approved in 2011..."
My " guess" is that Nobori has been approved by the PMDA team examining it. Members of the Kyoto University planning the coming trial has link with Japan's PMDA experts deciding Nobori's approval.
However there is always some delay from time decision to approved and the anouncement of the approval. PMDA has to infom the Ministry of Health Labour and Welfare, MHLW. The relevant person at MHLW will then notify the applicant, Terumo, regarding the approval. Then it is up to the applicant to announce their having receives the approval. In the case of Nobori, I believe Terumo will first inform Biosensors and they both will co-ordinate the time of announcing of the approval.
Question is will they want to announce the approval this financial year - ending 31March 2011. Or wait till the new financial year beginning Apr 2011.
NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial Will You Be First? retweet The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice... Date First Received: February 24, 2011 Last Updated: February 24, 2011 Verified by: Kyoto University, Graduate School of Medicine, February 2011 Clinical Trial Phase: Phase 4 | Start Date: May 2011 Overall Status: Not yet recruiting Estimated Enrollment: 3200 Brief Summary Official Title: “NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial” Condition Keyword(s): •Coronary Artery Disease Additional Keyword(s) Provided by Sponsor: •Coronary stent Intervention(s): •Device: Biolimus-eluting stent •Device: Everolimus-eluting stent ADVERTISEMENT BY GOOGLE Condition MeSH Term(s), Assigned with an Experimental Algorithm: •Coronary Artery Disease •Coronary Disease Intervention MeSH Term(s), Assigned with an Experimental Algorithm: •Everolimus The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. Study Type: Interventional Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment Study Primary Completion Date: June 2015 Detailed Clinical Trial Description Everolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Biolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in 2011 by the Japanese Ministry of Health, Labor and Welfare. It has been reported that biolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 9 months as compared with paclitaxel-eluting stent. However, trial results comparing biolimus-eluting stent with everolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.
any news about approvals, Japan or China???
Medtronics reported their Q3 2011 results : Short extract from www.cardiovascularbusiness.com
" Finally, its cardiovascular revenue of $774 million grew 7 percent as reported. Revenue growth was driven by “solid performance in all businesses and particularly in emerging markets, where revenue growth was 30 percent compared to the same period in the prior year,” the company said.
The coronary and peripheral, structural heart and endovascular businesses grew worldwide revenue of 4 percent, 13 percent, and 12 percent, respectively, on a constant currency basis.
“While the stent market continues to experience year-over-year declines, Medtronic gained share with its highly deliverable Integrity platform,” said the company, adding that its U.S. market share in bare-metal stents was up nearly 9 percentage points compared with the same period in the prior year.
For info.
Moved back to 1.10. TP of 1.30 should be coming. 
CRTONLINE will be hosting their annual cardiology conference this Sunday, from 27th Feb to 01St Mar.
One of the seesions will be " Japan-USA Regulatory Synergies in Device Innovation" .
And in this session, one of the topics to be discussed is " Bioabsorbable Polymers in DES: From “Japan Last” to “Japan First”?
In other words, this topic is suggesting that between Japan and USA, Japan will most likely overtake USA in the area of Bioabsorbable Polymers in DES.
This scenario is most likely, as no company has instituted any such 'bioabsorbable polymer DES' program in the US mkt yet, while Japan is awaiting the approval of the Nobori DES from Terumo/Biosensors.
Again, another quotation from Nomura's analyst dated 17th Feb 2011.
Quote "
In our view, another uncertainty surrounding the stock is Nobori’s impending approval in Japan. While it is not possible to predict regulatory actions, we believe Nobori’s approval is not a question of if, but when.
In its recent 4Q10 results, Boston Scientific warned of a potential DES market share loss in Japan on the back of the launch of a new product by a “Japanese competitor” in early 2011 (presumably Terumo, in our view)." Unquote.
For Info. Not a call to buy/sell/hold or short.
Losing patience on Nobori’s approval in Japan?
Bio has the makings of a busted descending triangle where it peaked @ 1.26, support @ 1.10. The rebound from 0.96 will hit a wall at the now Resistance 1.10 (previous support of desc triangle) before retreating. However, if mkt approvals come from north asia, this would be a very strong busted pattern.
Let us wish each other well, whether we are buying or shorting. Stock prices goes up and down, depending on fundamentals as well as sentiment.
In fairness, I would say that the technical breach of 1.10 on 10 th Feb was a technical sell signal, and if you are looking at a shorter term perspective, it was a calculated move, and on hindsight, the right one, provided that the short has been covered.
Again, not a call to buy/sell/hold or short.
He smart to short, hoh? When it reaches $1.10, he might even wet his pants. Hahaha.
Madnezz ( Date: 23-Feb-2011 18:41) Posted:
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OK Ipunter - you seem to have inside trak. What next? how long till back to $1.26 or above?
He might have bought back at 0.96 liao
hope he did not burn, we are all here to earn money
infancybird ( Date: 23-Feb-2011 11:58) Posted:
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Wah, metaphoricsymbol very " zhun"
iPunter ( Date: 20-Feb-2011 15:19) Posted:
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powerr sioll.. being bought up by the millions by institutions which arent likely to take small profit in the short term so dont expect it to be coming down anytime soon!
Happen to remember our forum contributing member abkxpres referring to some of us as roast ducks and can make money out of us, hopefully he has all his short position covered before last week end lest he will be roasted and eaten by those he had make fun of. BIG rise in heavy volume of about> 10% and this augur well for its future.
abkxpres ( Date: 11-Feb-2011 14:09) Posted:
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