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.
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