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French coronary stent maker aims to take on U.S. rivals with flexible bare metal stent

January 11, 2013 11:59 am by | 5 Comments

Conventional coronary stents are made of steel, while some are made of advanced alloys like chromium.

But no matter what they are made of, they are all rigid and are hamstrung by that very fact, believes Gonzague Issenmann, CEO of French stent maker STENTYS. That’s because they tend to have an imperfect fit inside the artery and these so-called malapposed stents have significant risks including the chance of re-clotting leading to a repeat heart attack.

Issenmann and chief financial officer Stanislas Piot were at the J.P. Morgan Healthcare Conference earlier this week in San Francisco to pitch investors about the company’s products including a flexible stent made of titanium alloy that fits and adapts to the size of the artery. The STENTYS Bare Metal Stent prevents gaps from forming between the stent and artery walls, explained Issenmann in an interview Tuesday.

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Because of its flexible nature, the stent does not require the use of a balloon catheter needed by conventional stents to be delivered inside the artery to remove the blood clot formed that results in a heart attack.

The STENTYS Bare Metal Stent has been cleared by European regulators and Issenmann explained that a pivotal, randomized trial of 880   patients is expected to begin in April in the U.S.. The data from that trial is intended to support a premarket approval for the product, which is expected in late 2015, early 2016, Issenmann said.

If approved, the STENTYS BMS will be the only other cardiac stent — aside from one made by Abbott — to have an indication for acute myocardial infarction and specifically ST elevation myocardial infarction. Boston Scientific previously had a stent bearing the AMI indication, but it is being replaced, Issenmann said. Medtronic has no competing product.

The coronary stent market for acute myocardial infarction was $2 billion in 2011 and is expected to grow to $3 billion in 2017, according to an investor presentation prepared by the company. Before launching in the U.S., Issenmann wants to expand the product’s use in Europe as well as introduce it in the Middle East and in South America. Next year, he intends to launch the product in Asia.

STENTYS, which trades on the Paris Stock Exchange, currently has 36 employees and about $60 million in the bank. Projected revenue for 2012 is about $3 million. Issenmann expects that the R&D team in Princeton, New Jersey would expand once the clinical trial launches in the U.S. in April.

The video below shows the properties of the self-expanding STENTYS stent

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Arundhati Parmar

By Arundhati Parmar

Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.
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5 comments
rachelr
rachelr

"Because of its flexible nature, the stent does not require the use of a balloon catheter needed by conventional stents to be delivered inside the artery to remove the blood clot formed that results in a heart attack."  I thought catheters were necessary to expand the stent within the vessel, rather than to remove blockage?

Arundhati Parmar
Arundhati Parmar

 @rachelr Yes you are right. I was explaining how a stent functions to remove a clot and not the catheter, although I see how the sentence can be taken that way. Sorry ...

rachelr
rachelr

 @Arundhati Parmar  @rachelr   The reason I was asking was mainly do you know what benefit the flexibility is supposed to give? Stents tackle vessel narrowing rather than clots - they compact enlarged areas of the vessel wall to widen the space available for blood flow.  The balloon doesn't only feed the stent to the target site, it also helps it to expand and push onto the vessel wall, so flexibility seems counterintuitive if it is self-expanding?

rachelr
rachelr

 @Arundhati Parmar Ok, so it expands to variable diameters in more complex vessels?  Ok, that makes sense.  Thanks!

Arundhati Parmar
Arundhati Parmar

 @rachelr Like the story mentions the flexibility allows the stent to expand on its own and provide better fit while more rigid, conventional stents leave gaps leading to malapposition that has significant risks from what I understand.