Tryton Medical announced on 25 May 2010 results from the company’s Tryton Side Branch Stent System presented during a Tryton-sponsored symposium in conjunction with the EuroPCR 2010 conference in Paris.
Robert-Jan Van Geuns, senior cardiologist at Erasmus Medical Center, Rotterdam, The Netherlands, presented data from the Rotterdam-Poznan Series, a two-centre consecutive series that included 100 lesions from 96 patients followed for six months. Results from the Rotterdam-Poznan Series demonstrated a procedural success rate of 94% and a rate of target vessel revascularisation of 4% at six months. The stented artery was a left main coronary artery in 8% of the cases examined in the series.
Maciej Lesiak, University Hospital in Poznan, Poland, presented acute data from the E-Tryton 150 study, a multicentre consecutive registry performed at eight leading European centres. The study enrolled 150 consecutive patients who received the Tryton Side Branch Stent. Results from the E-Tryton registry show a procedural success rate of 98.5% from treatment of bifurcation lesions with a wide distribution of angles and anatomic locations, including the left main coronary artery.
“Data presented at the Symposium contributes to the growing body of evidence demonstrating impressive acute procedural outcomes using the Tryton strategy,” said Martin B Leon, New York-Presbyterian Hospital/Columbia University Medical Center, who chaired the event. “The clinical data from Rotterdam-Poznan shows the durability of these results at six months which is consistent with the positive data from the first-in-man study.”
Current approaches to treating bifurcation lesions have significant limitations, including higher rates of thrombosis – potentially fatal blood clots – and restenosis, the re-narrowing of the stented vessel following implantation. Tryton’s innovative solution to the persistent problem presented by bifurcation lesions is the Tryton Side Branch Stent System, which offers a dedicated strategy for bifurcation stenting across a broad range of anatomic angles and locations.
Widespread adoption of stenting for left main disease has been hampered by the lack of a robust strategy for bifurcations lesions, which represent more than 75% of left main lesions. A Tryton strategy for left main disease has the potential to provide an important tool as stenting becomes established as a standard treatment for left main disease.
About the Tryton Side Branch Stent System
The Tryton Side Branch Stent System is designed to offer a dedicated strategy for treating atherosclerotic lesions in the side branch at the site of a bifurcation. Tryton’s highly deliverable cobalt chromium stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel.
The Tryton Side Branch Stent System demonstrated excellent six-month clinical results in a first-in-man study of the system in 30 patients, with no restenosis occurring in the side branch artery. The stent system has received CE mark approval in Europe and is commercially available in Austria, Belgium, Denmark, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, and the United Kingdom. It has been used to treat more than 1,250 patients with bifurcation disease.
The Tryton Side Branch Stent System is not approved in the United States.