The problem with Biotronik

[Anonymous]

Spoken like a true last place performer. You keep sticking to that logic my friend. "Leverage"???? That is a completely foriegn land for BIO...however there is the illegal brand of leverage that BIO created but that's for another time and place.

google DOJ fines for Medtronic, St Jude, BSX and Biotronik. No doubt who is putting their money where their mouths are based on the volume $$$ being paid as a result of breaking the law.

 

[Anonymous]

Bio has stents, DES, peripheral, bio-degradeable, etc in its pipeline. Bio is also the perfect company to align with companies such as JNJ and Abbott. Don't write us off so soon grasshopper.

Pipeline, schmipeline Poster.... who cares what is in a company's "pipeline" ?

Sounds a lot like internal cheerleading, IMHO.
What matters is what's in the bag, Dude.
And the F.D.A. decides this.

Anything else is cheap swampland in Florida / the DOW hitting 20000 by December.
Catch my drift, Jose ?

 

[Anonymous]

Pipeline, schmipeline Poster.... who cares what is in a company's "pipeline" ?

Sounds a lot like internal cheerleading, IMHO.
What matters is what's in the bag, Dude.
And the F.D.A. decides this.

Anything else is cheap swampland in Florida / the DOW hitting 20000 by December.
Catch my drift, Jose ?

Good Lord they've been talking about, showing to US Physicians, their famous stent since 1995, without moving forward to full market release in 18 years. The company is pathetic; the Germans will never understand the American market, and moreover, disdain them. After the latest go around, spending big bucks on the cast-aways, without much market increase, there has to be a lot of unhappy owners with US results....

 

[Anonymous]

Simple analogy : if you are a hound dog chasing after a raccoon, you really want to make sure you are barking up the right tree.

The mainstream CRDM business is becoming commercialized and managed care ( truly a misnomer) is extracting more profit from the gig than the manufacturers.

Talk about a broken business model.

 

[Anonymous]

Simple analogy : if you are a hound dog chasing after a raccoon, you really want to make sure you are barking up the right tree.

The mainstream CRDM business is becoming commercialized and managed care ( truly a misnomer) is extracting more profit from the gig than the manufacturers.

Talk about a broken business model.

True

 

[Anonymous]

If you toured MDT vascular and then toured BIO in Germany, you may feel different. Ask any MD who has been to both tours.

Abbott talks big with BVS yet its well known that the sent is hard to see and rumored to be stiff so in tortuous anatomy? no chance.

Both orsiro(with sirolimus) and Bostons (synergy) will be the market leaders in the US come late 2015. BSX is being quiet but thier product will outdeliver Abbott by a wide margin

Think of it this way, even if Bio gets 25% share in this new stent market, that one product takes a 1.2 billion dollar company to 3 billion OVERNIGHT.

Wake up folks.

 

[Anonymous]

If you toured MDT vascular and then toured BIO in Germany, you may feel different. Ask any MD who has been to both tours.

Abbott talks big with BVS yet its well known that the sent is hard to see and rumored to be stiff so in tortuous anatomy? no chance.

Both orsiro(with sirolimus) and Bostons (synergy) will be the market leaders in the US come late 2015. BSX is being quiet but thier product will outdeliver Abbott by a wide margin

Think of it this way, even if Bio gets 25% share in this new stent market, that one product takes a 1.2 billion dollar company to 3 billion OVERNIGHT.

Wake up folks.

I have no basis to refute any of this, BUT the timeline. If you think we (BIO) are going to market with bioabsorbable in late 2015...when do you think we will be going to the US market with a BMS? When do the conversations about the look, size and training of the VI Field Force
start?
For example, Jake was asked during the Town Hall session of the NSM in Dallas this year whether the current CRM Field Force would be given VI, or if an entirely new business group would and his response was so unrehearsed and far-afield that it was apparent its certainly not on his radar screen.

Don't get me wrong...I love BIO, but I long ago gave up on counting my chickens before they hatch when it comes to our pipeline. The European Clinical Data you cited earlier does not carry much weight with the FDA...our MRI Safe efforts should evidence of that.

I hope, however, you are right, particularly on the Timeline...by late 2015, a breakthrough product like bioabsorbable will be the shot-in-the-arm many of us will need as the CRM industry continues is downward spiral.

 

[Anonymous]

I joined BIO in 2005. A relative maverick I guess at the time. The stent was promised as 3 years away then.

 

[Anonymous]

changed the drug from paclitaxel to Sirolimus which is one of the reasons its been delayed.

It will put BIO on the vascular map. Look at the sales market in Europe. 90% of the time, the US market follows the markets in germany, etc when it comes to vascular.

I spoke with an abbott person recently about their BVS, he had no clue as their clinicals are still not underway(Though he seemed to think it would be soon) BIO as of 3 months ago was hiring clinicals for stent trials.

Bottom line, its a real game changer given Bios current revenue

 

[Anonymous]

changed the drug from paclitaxel to Sirolimus which is one of the reasons its been delayed.

It will put BIO on the vascular map. Look at the sales market in Europe. 90% of the time, the US market follows the markets in germany, etc when it comes to vascular.

I spoke with an abbott person recently about their BVS, he had no clue as their clinicals are still not underway(Though he seemed to think it would be soon) BIO as of 3 months ago was hiring clinicals for stent trials.

Bottom line, its a real game changer given Bios current revenue

Correct me if I am wrong, but the trials you are speaking of are for BMS...not bioabsorbable. Assuming the trials go well, I could see being on the market next year with a BMS product. More support for this, as you have pointed out, is the Field Force being built up.

However, if you think we will have bioabsorbable approved and on the market in 2015, you must be anticipating 510k approval for that product based on BMS, and I think thats where the problem lies...bioabsorbable is an entirely new ballgame and will be subject to the FDA's most intense scrutiny...not a rubber stamp thats puts patients in the path of another Durata or Fidelis.

 

[Anonymous]

Google Orsiro, Its very similar to what BSX will have, THe stent won't completely absolve like the abt BVS yet its polymer is bioabsorbable, BEEV on the market in europe for 2 years. Very thin strut that will completely endotheliaze in 3 months with a rumored 3 month plavix indication.

Reason so many dismiss it? the ORIGINAL drug coating was a taxus like drug, in its first head to head with abt, abt had better outcomes. Now, Orsiro has the sirolimus drug, same drug that 90% of DES platforms have

Muchh info and excitement about this very flexible and deliverable stent. Abt BVS is getting all the press but my sources tell me "you cant see it and its not very flexible"- ouch........

Those are very important features on any stent, especailly to the pivate MD's who like to get case done quickly so they can get to the next one.

 

[Anonymous]

Orsiro: Industry's first hybrid drug eluting stent with a bioabsorbable polymer

A unique solution for treating coronary artery stenosis with a hybrid combination of passive and active components:

Passive component: PROBIO encapsulates the stent and reduces interaction between the metal stent and the surrounding tissue.


Active component: BIOlute consists of a limus drug and a bioabsorbable polymer matrix which achieves a controlled drug release.



Advanced stent design

The stent platform for Orsiro is PRO-Kinetic Energy, our sixth generation of coronary bare metal stents. The stent material is a cobolt chromium alloy which allows for thinner struts while maintaining optimal radial strength and radiopacity. The thin struts of only 60 µm also result in exceptional flexibility and deliverability of the stent in even the most challenging vessels.


Stent Delivery System: Pantera balloon technology

Thanks to our modern balloon technology deliverability of the stent is effortless and smooth. The Enhanced Force Transmission Shaft (EFT) adds pushability and trackability to this high performing device.


New DES specific crimping

An advanced crimping technique ensures a low crossing profile (0.99 mm/0.039") and secure stent retention without affecting the BIOlute coating.



Clinical publications & abstracts

Tittelbach, M; Diener, T; Orsiro – The First Hybrid Drug-eluting Stent, Opening Up a New Class of Drug-eluting Stents for Superior Patient Outcomes

Interventional Cardiology, 2011;6(2):142–4

Abstract:

The Orsiro device is a hybrid drug-eluting stent that represents a new strategy in the treatment of coronary artery stenosis. Orsiro features a hybrid coating of passive and active components: the PROBIO passive coating seals the metal surface of the stent and prevents interaction with the surrounding blood and tissue, while the BIOlute active coating contains a highly biocompatible polymer that delivers a -limus drug over 12–14 weeks and degrades gently over one to two years, thereby avoiding increased inflammation. The stent backbone is the PRO-Kinetic Energy platform, which has a double-helix stent design and thin struts, bringing flexibility and ease of deliverability.

click here





Questions regarding this product?

Please fill out the contact form with your request for additional information, and you will receive an answer within 24 hours.

Contact Information:





* Mandatory fields




Orsiro


Main product information site

 

[Anonymous]

To be honest no real problems other than the downward ASP pressure that all companies are facing. Sales continue to rise and Biotronik has become a legitimate option in the CRM market space.

 

[Anonymous]

Orsiro: Industry's first hybrid drug eluting stent with a bioabsorbable polymer

A unique solution for treating coronary artery stenosis with a hybrid combination of passive and active components:

Passive component: PROBIO encapsulates the stent and reduces interaction between the metal stent and the surrounding tissue.


Active component: BIOlute consists of a limus drug and a bioabsorbable polymer matrix which achieves a controlled drug release.



Advanced stent design

The stent platform for Orsiro is PRO-Kinetic Energy, our sixth generation of coronary bare metal stents. The stent material is a cobolt chromium alloy which allows for thinner struts while maintaining optimal radial strength and radiopacity. The thin struts of only 60 µm also result in exceptional flexibility and deliverability of the stent in even the most challenging vessels.


Stent Delivery System: Pantera balloon technology

Thanks to our modern balloon technology deliverability of the stent is effortless and smooth. The Enhanced Force Transmission Shaft (EFT) adds pushability and trackability to this high performing device.


New DES specific crimping

An advanced crimping technique ensures a low crossing profile (0.99 mm/0.039") and secure stent retention without affecting the BIOlute coating.



Clinical publications & abstracts

Tittelbach, M; Diener, T; Orsiro – The First Hybrid Drug-eluting Stent, Opening Up a New Class of Drug-eluting Stents for Superior Patient Outcomes

Interventional Cardiology, 2011;6(2):142–4

Abstract:

The Orsiro device is a hybrid drug-eluting stent that represents a new strategy in the treatment of coronary artery stenosis. Orsiro features a hybrid coating of passive and active components: the PROBIO passive coating seals the metal surface of the stent and prevents interaction with the surrounding blood and tissue, while the BIOlute active coating contains a highly biocompatible polymer that delivers a -limus drug over 12–14 weeks and degrades gently over one to two years, thereby avoiding increased inflammation. The stent backbone is the PRO-Kinetic Energy platform, which has a double-helix stent design and thin struts, bringing flexibility and ease of deliverability.

click here





Questions regarding this product?

Please fill out the contact form with your request for additional information, and you will receive an answer within 24 hours.

Contact Information:





* Mandatory fields




Orsiro


Main product information site

One abstract? From 2011?? Overwhelming evidence, or lack of interest???