News | May 24, 2011

Tryton Bifurcation Stent Shows Positive Data From Three European Registries

May 24, 2011 – Tryton Medical Inc. announced positive results in three “real world” European registries of the company’s Tryton Side Branch Stent System for the treatment of atherosclerotic lesions in the side branch at bifurcations.

Six-month results of the E-Tryton 150 and E-Tryton Benelux registries from 300 patients demonstrated a low (6.1 percent) rate of major adverse cardiac events (MACE) and a low (3 percent) rate of target lesion revascularization (TLR), with no occurrence of late stent thrombosis at six months. The device also demonstrated a high rate of procedural and technical success.

“The results of these two registries give us data that helps us better understand how the Tryton Side Branch Stent System performs in real-world practice,” said Pieter R. Stella, M.D., Ph.D., director of the heart catheterization laboratories and clinical cardiovascular research at the University Medical Centre in Utrecht, the Netherlands, who presented the results at EuroPCR 2011. “The stent system’s promising safety profile and very good MACE and TLR rates consistently demonstrate reliable clinical outcomes for difficult-to-treat bifurcation lesions.”

A total of 302 consecutive patients were enrolled in the E-Tryton 150 and E-Tryton Benelux studies at 15 centers in The Netherlands, Belgium, Luxemburg, Ireland, Poland, Latvia, France and Spain. The primary endpoint of the studies is the overall rate of major adverse cardiac events (MACE) at six months following the procedure. MACE is defined as cardiac death, myocardial infarction and target lesion revascularization (main and/or side branch).

In addition, on May 18 at EuroPCR, Desale Solomon Asgedom, M.D., of the Beaumont Hospital in Dublin, Ireland, reported on the third registry of clinical experience at his center with patients treated with the Tryton Side Branch Stent. With a mean follow up of 17.8 months, data from 169 patients demonstrated a TLR rate of 2.3 percent and no late stent thrombosis.

“These favorable findings, which demonstrate TLR rates in line with drug-eluting stent-like results, continue to build the growing body of clinical evidence for the Tryton Side Branch Stent System,” said Rick Anderson, board member of Tryton and managing director of PTV Sciences. “We are pleased with this positive clinical data and we look forward to additional results from the randomized pivotal trial of the device, which is currently enrolling patients in the United States.”

Also on May 18, the company hosted a “How Should I Treat” session, chaired by Thierry Lefèvre, head of the Interventional Cardiology Department and Research at the Institut Cardiovasculaire Paris Sud at Institut Hospitalier Jacques Cartier in Massy, France. The session focused on case presentations and bifurcation treatment. Participants of the session discussed an investigator-sponsored left main study of the Tryton Side Branch Stent for the treatment of left main disease. Until recently, left main disease has been treated with bypass surgery. (The Tryton Side Branch Stent System has not been studied extensively for the treatment of left main disease.)

Coronary artery disease often results in the buildup of plaque at the site of a bifurcation, where one artery branches from another. Current approaches to treating these lesions are time consuming and technically difficult. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. Bifurcation lesions account for as many as one-third of all coronary lesions.

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