August 30, 2014 12:42 AM ET

Healthcare Equipment and Supplies

Company Overview of Tryton Medical, Inc.

Company Overview

Tryton Medical, Inc. manufactures and sells stent systems for the treatment of bifurcation lesions. The company offers Side Branch Stent System, which is used to treat a range of bifurcated lesions; and products for the treatment of left main coronary artery disease. It sells its products through distributors in Austria, the Benelux countries, Czech Republic, Slovak Republic, Latvian Republic, Denmark, Germany, Hungary, Ireland, Israel, Italy, Jordan, Pakistan, Poland, Portugal, the Russian Federation, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, the United Arab Emirates, and the United Kingdom. The company was founded in 2003 and is based in Durham, North Carolina.

1000 Park Forty Plaza

Suite 325

Durham, NC 27713

United States

Founded in 2003

Phone:

919-226-1490

Fax:

919-226-1497

Key Executives for Tryton Medical, Inc.

Chief Executive Officer
Age: 45
Co-Founder and Chairman
Age: 67
Founder and Director
Chief Financial Officer
Age: 46
Chief Technical Officer
Compensation as of Fiscal Year 2014.

Tryton Medical, Inc. Key Developments

Tryton Medical, Inc. Receives CE-Mark for the Left Main Indication

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

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

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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