Stentys announces the publication of new Self-Apposing stent in left main coronary artery study

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New data on Stentys’ Self-Apposing stent in treating the left main coronary artery has been published in the peer-reviewed journal Catheterization and Cardiovascular Interventions. The authors concluded that the Stentys drug-eluting stent offers a valid treatment alternative for this indication.

When treating  patients with left main coronary artery disease, especially in the context of a heart attack, the large diameter of the left main artery and the significant vessel tapering at that location represents serious challenges for conventional balloon-expandable stent that often result in important stent structural deformations. The Stentys stent can adapt to vessels with varying diameters and ensure optimal fit to the vessel wall along the entire stented length.

The single-centre, retrospective, two-arm, controlled study, led between February 2012 and September 2013 by a team headed by Carlo Briguori, Clinica Mediterranea, Italy, included 75 consecutive patients with tapered distal unprotected left main coronary artery lesions treated with the Stentys drug-eluting stent. A control group of 75 patients treated with second-generation balloon-expandable stents over the same period was selected from the New Tokyo Hospital, Chiba, Japan, database.

The results, assessed by intravascular ultrasound (IVUS), showed that the final minimal lumen area was larger in the Stentys group (left main: 17.45±3.45 vs. 14.84±3.45mm2; p<0.001) even though the final balloon diameter was smaller (3.62±0.49 vs 4.51±0.51mm; p<0.001), reducing the risk of vessel injury.

“In the very complex indication of left main artery disease, the Stentys stent achieved 100% procedural success rate, 9.3% MACE rate at 12 months and, most importantly, larger vessel lumen than second generation balloon-expandable drug-eluting stent without the need for aggressive over-dilation,” said Briguori. 

Gonzague Issenmann, co-founder and chief executive officer of Stentys commented: “This study shows that the Self-Apposing technology represents a compelling alternative to treat left main coronary artery disease and provides further clinical proof of the perfect adequacy for vessels of varying diameters.”