Healthcare Equipment and Supplies
Company Overview of Tryton Medical, Inc.
Tryton Medical, Inc. manufactures and sells side branch stent systems for the treatment of coronary bifurcation lesions patients. It offers its products through a network of distributors internationally, as well as provides for investigational needs in the United States. The company was founded in 2003 and is based in Durham, North Carolina.
1000 Park Forty Plaza
Durham, NC 27713
Founded in 2003
Key Executives for Tryton Medical, Inc.
Chief Executive Officer, President and Director
Vice President of Regulatory and Quality
Compensation as of Fiscal Year 2014.
Tryton Medical, Inc. Key Developments
Tryton Medical, Inc. Receives CE-Mark for the Left Main Indication
Feb 13 14
Tryton Medical, Inc. announced that it has received CE Mark for the treatment of Left Main Coronary artery disease. With this approval, Tryton Medical becomes the first company to earn a CE Mark for this indication. Left main disease, an accumulation of plaque that narrows the base of the coronary tree, is a persistent challenge in interventional cardiology, as more than 75% of left main lesions are bifurcations. There are approximately 200,000 cardiac surgeries performed in left main annually.
Tryton Medical, Inc. Announces First Results from Pivotal Study of the Tryton Side Branch Stent Presented at TCT 2013 Annual Meeting in Late Breaking Clinical Trial Session
Oct 30 13
Tryton Medical, Inc. announced the first results from the Tryton Side Branch Stent Pivotal IDE trial were presented during a Late Breaking Clinical Trial session at the 25(th) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. The Tryton Pivotal IDE trial is an international, randomized study that compares a Tryton Side Branch Stent to conventional provisional treatment (balloon angioplasty) in the side branch, with both study groups receiving a standard drug eluting stent (DES) in the main vessel. The study, which is the first randomized FDA IDE pivotal clinical trial to evaluate a dedicated bifurcation stent, enrolled 704 patients at 67 centers in North America and 11 countries throughout Europe and Israel. It is larger coronary bifurcation study ever conducted and the first study to employ core lab angiographic (3D and planar) and IVUS analysis. Key findings from the study include: Both the Tryton strategy and the provisional strategy appeared to be safe, with rare clinical post procedure myocardial infarctions, low rates of stent thrombosis, and no cardiac death. Both study arms had low 9-month clinically driven target vessel revascularization, or TVR (Tryton 4.7%; Provisional 3.6%). Tryton, compared to the provisional arm of the study, did not meet the non-inferiority clinical endpoint of target vessel failure (TVF)1, driven in large part by peri-procedural CK-MB elevations (Tryton 17.4%; Provisional 12.8%). 60% of the side branch vessels treated were smaller than the intended study population of side branch vessels of 2.25 mm diameter or greater by QCA. Tryton, compared to the provisional arm of the study, demonstrated superiority in reducing percent diameter side branch stenosis (Tryton 31.6%; Provisional 38.6%; p=.002), the powered secondary endpoint. Post hoc subgroup analysis of the intended study population demonstrated Tryton out performed the provisional arm of the study in TVF (Tryton 11.3%, Provisional 15.6%) as well as reduced percent diameter stenosis (Tryton 30.4%; Provisional 40.6%; p=.004).
Tryton Medical Announces CE Mark and European Launch of Next-Generation Tryton Side Branch SHORT Stent
May 16 13
Tryton Medical, Inc. announced that the company received the CE Mark for the Tryton Side Branch SHORT Stent, a novel coronary stent system that broadens the treatment options in bifurcations in large vessels with a short main branch landing zone. The Tryton Side Branch SHORT Stent length is 15 mm, or 3mm shorter in the main branch zone than the standard Tryton Side Branch Stent. The company is launching the product immediately in CE Mark countries. This innovation leverages the company's proprietary, first-in-class Tri-ZONE(R) technology and adds to the Tryton family of stents. The company will launch the Tryton Side Branch SHORT Stent during EuroPCR 2013 in Paris at their exhibitor booth #M27. The Tryton Side Branch SHORT Stent is supported by the robust clinical evidence of the Tryton Side Branch Stent. Published data from more than 1,000 patients treated with the Tryton Side Branch Stent in more than 8 European post-marketing registries demonstrated low target lesion revascularization rates of 2.9% at six months and 4.0% at one year, and a low 0.5% thrombosis rate at one year. More than 7,500 patients have been treated with the Tryton Side Branch Stent and it is commercially available throughout Europe, Russia and the Middle East. The Tryton Side Branch Stent is an investigational device in the United States. Tryton has completed enrollment in the first and only randomized controlled U.S. IDE pivotal clinical trial evaluating a dedicated bifurcation stent and anticipates study outcomes will be presented at TCT 2013 in San Francisco.
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September 3, 2014