Pathologist Highlights Question Of Stent Sizing. Could The Stentys Self-Apposing™ Device Be The Answer?

In short

More news from ACC in Chicago this week in the form of a press release from medical technology company STENTYS S.A., as it endeavours to show us how its clever self-expanding (Self-Apposing™)  stent addresses specific challenges highlighted during a presentation by world renowned pathologist Dr. Renu Virmani (CVPath Institute, Gaithersburg, Md.).

Background 

Stenting as a treatment option in acute myocardial infarction is complicated by the existence of a clot and contraction of the vessel, both of which make assessment of appropriate stent size difficult. According to the Stentys release, when selecting a conventional stent size, cardiologists can end up either undersizing (causing malapposition) or oversizing (causing vessel wall disruption), both of which lead to increased risk of heart attack recurrence.

Indeed in a study by Dr Virmani entitled “Histomorphologic Determinants of Early Stent Thrombosis in Human Coronary Arteries” the author analysed conventional stents in patients who had died shortly after a heart attack. Microscopic assessment  comparing those where a clot re-appeared (stent thrombosis) with those that remained clot-free, the researchers concluded that malapposition and vessel wall disruption were two strong predictors of early stent re-clotting.

The Stentys solution?

The STENTYS Self-Apposing™ Stent solves this stent-sizing dilemma. It “fits snugly” into the contour of a blood vessel, and its shape and diameter adapt as the vessel dilates and the initial clot dissolves during the post-AMI phase, eliminating malapposition and its major complications seen with all other conventional stents.

Dr. Virmani’s study — “Histomorphologic Determinants of Early Stent Thrombosis in Human Coronary Arteries” — is an autopsy trial of patients who died shortly after a heart attack treated with conventional stents. It analyzed their stents under microscope, comparing those where a clot re-appeared (stent thrombosis) with those that remained clot-free. The study concluded that malapposition and vessel wall disruption were two strong predictors of early stent re-clotting.

Investigator comments 

“Early stent thrombosis in patients with acute myocardial infarction is a dreadful problem for both drug-eluting and bare-metal stents because of its catastrophic consequence, a recurrent heart attack. We need new stent designs such as self-expanding stents to reduce it and improve patient outcomes,” said Dr. Virmani.

Company comments

“Dr. Virmani found further evidence that, because the cardiologist is not empowered to properly assess vessel size, the utilization of conventional stents to treat heart attacks will inevitably lead to poorer clinical outcomes,” said Gonzague Issenmann, CEO and co-founder of STENTYS. “Fortunately, impressive clinical trial results are demonstrating that the STENTYS Self-Apposing™ technology is designed to overcome the serious limitations of conventional stents and to be the best solution for treating heart attack patients.”

A bit more about Stentys

Based in Princeton, N.J., and Paris, STENTYS has developed a new generation of stents to treat acute myocardial infarction (AMI). Founded by Jacques Séguin, M.D., Ph.D., (also founder of CoreValve, which was acquired by Medtronic) and Gonzague Issenmann, STENTYS received CE-marking for its flagship products in 2010. Its Self-Apposing™ stent adapts to the anatomic changes of the artery in the post-infarction phase and thus prevents the malapposition problem associated with conventional stents. STENTYS has commenced marketing activities in several European countries.STENTYS

Source: Stentys, Business Wire